Author: "Bockstal, Viki" - Searchworks@Jio Institute Digital Library Search Results

Your search keyword '"Bockstal, Viki"' showing total 49 results

Start Over Author "Bockstal, Viki"

49 results on '"Bockstal, Viki"'

1. Prediction of long-term humoral response induced by the two-dose heterologous Ad26.ZEBOV, MVA-BN-Filo vaccine against Ebola

Author: Alexandre, Marie, Prague, Mélanie, McLean, Chelsea, Bockstal, Viki, Douoguih, Macaya, and Thiébaut, Rodolphe
Published: 2023
Full Text: View/download PDF

2. Non-human primate to human immunobridging demonstrates a protective effect of Ad26.ZEBOV, MVA-BN-Filo vaccine against Ebola

Author: Bockstal, Viki, Leyssen, Maarten, Heerwegh, Dirk, Spiessens, Bart, Robinson, Cynthia, Stoop, Jeroen N., Roozendaal, Ramon, Van Effelterre, Thierry, Gaddah, Auguste, Van Roey, Griet A., Solforosi, Laura, Zahn, Roland, Callendret, Benoit, Hendriks, Jenny, Luhn, Kerstin, Douoguih, Macaya, Schuitemaker, Hanneke, and Van Hoof, Johan
Published: 2022
Full Text: View/download PDF

3. Safety and immunogenicity of the two-dose heterologous Ad26.ZEBOV and MVA-BN-Filo Ebola vaccine regimen in children in Sierra Leone: a randomised, double-blind, controlled trial

Author: Kargbo, M, Bockarie, E, James, N L, Kabbah, A, Kamara, A, Koroma, K H, Langley, S O, William, N, Kessebeh, R, Mooney, T, Conteh, L, Smout, E, Allieu, K, Bangura, K, Bangura, M S, Bangura, M A, Jalloh, H, Jalloh, A B, Kamara, I, Kamara, M, Konteh, A, Koroma, S, Marrah, C, Sesay, M, Sesay, M T, Deen, A T, Jalloh, A, Kaimbay, R M, Kain, D, Kamara, E L, Kamara, M P, Kamara, O J, Kamara, S L M, Kanneh, M, Koroma, A H, Lahai, D, Mansaray, I S, Marah, W S, Massaquoi, M J, Nabie, A, Saidu, N S, Samai, I, Tengheh, J N, Turay, A S, Fornah, A, Sesay, F, Sow, A, Swaray, E, Mansaray, F, Ade-Cole, T, Bangura, L M, Conteh, M L, Koroma, A M, Koroma, M, Sam, A, Scott, T, Sessie, T, Sunders, J-H C, Turay, S I-S, Weekes, J, Sheku, M, Gibson, L, Kowuor, D, Ahamed, I, Allieu, W, Kabba, D U, Kamara, F J, Kebbie, M S, Pessima, M, Wurie, A, Bah, F, Bangura, A I, Bangura, R A S, Blango, L, Boima, S, Conteh, M, Conteh, Y, Daramy, M L, Fofanah, O, George, E, Hanson, T F, Jalloh, M I, Kalawa, M, Kamara, A M, Kamara, F E, Kamara, G M, Kamara, H M, Kamara, P B D, Kamara, R T, Kamara, R, Kanneh, D P, Komeh, I, Kuyateh, M, Mansaray, F F, Mansaray, M M, Sillah, A B, Tarawally, M A, Turya, O S, Yawmah, J B, Leigh, B, Watson-Jones, D, Greenwood, B, Samai, M H, Deen, G F, Marke, D, Sesay, T, Piot, P, Smith, P, Edmunds, J, Lees, S, Larson, H, Weiss, H, Wilson, P, Phillips, R, Maxwell, C, Ishola, D, Afolabi, M, Baiden, F, Akoo, P, Owusu-Kyei, K, Tindanbil, D, Bower, H, Stuart, J, Bah, O M, Rogers, B T, Serry-Bangura, A, Swaray, I B, Bangura, A, David, I J, Davies, D G M, Kallon, J A, Kamara, A B, Kamara, I F, Kamara, M M, Morovia, F E, Suma, F B, Thompson, F, Murray, M, Kakay, O, Suma, F, Sesay, I, Foster, J, Manno, D, Gallagher, K, Cox, S, Howard, N, Cesay, M, Torrani, P, Sharma, S, Snowden, E, Banks, T, Harber, T, Brown, J, Howard, K, Melton, N, Malcolm, S, Welsh, S, Eggo, R, Jendrossek, M, Pearson, C, Offergeld, K, Ferrault, C, Van Alst, M, Mahajan, N, Van Looveren, M, Van Ballaert, S, De Cnodder, T, Grobler, N, Roza, L, Liberi, T, Armishaw, L, Verkleij, C, Henrick, T, Banaszkiewicz, A, Lowe, B, Awuondo, K, Hafezi, H, Hancox, E, Kohn, B, Tuda, G O, Bangura, G, Kroma, M T, Fofanah, L, Pessima, A, Rogers, M, Sheriff, O, Ajala, T W, Fangawa, J, Foday Jr, S, Koroma, I S F, Mansaray, B, Mansaray, H A, Sesay, K, Charles, M K, Heroe, P C, Lamin Karbo, M, Yansaneh, I S, Gogo Egoeh, S, Trye, A, Amponsah, M, Donelson, L, Sylvester, T, Owira, V, Onyuka, G, Nambuchi, L, Oburu, A, Apollo, D, Vandi, L, Alghali, N D, Bah, A, Bangura, I J, Cole, A C, Fofanah, S, Jalloh, H U, Jalloh, K F N, Jalloh, N, Kabba, H U, Kabba, J N, Kabba, M, Kamara, J S, Kanjie, F, Kanu, A P, Kargbo, I, Kassa-Koroma, G, Koroma, S B, Sankoh, A, Sankoh, T, Sesay, O D, Wilhem, H, Williams, C T, Bangura, I, Ben-Rogers, Y, Jamboria, F J, Kamara, N, Kanawah, I, Kargbo, A T, Swaray, I, Amara, L, Bundu, I, Jakema, H B, Kamara, K, Sheku, M F, Adeleye, Q, Akhigbe, I, Bakalemwa, R, Chami, N P, Altmann, L, Kamara, B, van Roey, K, Conteh, P, Samura, M, Gandie, V, Marrah, M, Moinina, E, Kalokoh, J, Bosompem, S, Hilton, T, Jusu, M O, Borboh, P, Brima, A S, Caulker, A F Y, Kallon, A, Koroma, B, Macauley, R C, Saquee, T M D, Williams, H I, Bangura, A R, Fornah, J, Idriss, B, Sillah, M, Mackay, W, Aleghen, B, Murray, T, Edem-Hotah, J, Fatorma, T, Amara, F, Bangura, S, Bonnie, E, Sannoh, M, Donaldson, A, Ndingi, S, Nyaberi, D, Pereira, M, Rothwell, A, Vy, V, Nyallay, L, Fombah, A, Saidu, S, Dambo, T P, Fakaba, P J, Fatorma, M M E, Freeman, R H, Johnson, C L, Kogba, D B, Lahai, A, Vincent, W, Yambasu, N, Bangura, M, Tengbeh, A, Kabia, R, Nyakoi, A M, Callaghan, M, Enria, L, Lee, S, Afolabi, Muhammed O, Ishola, David, Manno, Daniela, Keshinro, Babajide, Bockstal, Viki, Rogers, Baimba, Owusu-Kyei, Kwabena, Serry-Bangura, Alimamy, Swaray, Ibrahim, Lowe, Brett, Kowuor, Dickens, Baiden, Frank, Mooney, Thomas, Smout, Elizabeth, Köhn, Brian, Otieno, Godfrey T, Jusu, Morrison, Foster, Julie, Samai, Mohamed, Deen, Gibrilla Fadlu, Larson, Heidi, Lees, Shelley, Goldstein, Neil, Gallagher, Katherine E, Gaddah, Auguste, Heerwegh, Dirk, Callendret, Benoit, Luhn, Kerstin, Robinson, Cynthia, Greenwood, Brian, Leyssen, Maarten, Douoguih, Macaya, Leigh, Bailah, and Watson-Jones, Deborah
Published: 2022
Full Text: View/download PDF

4. Safety and long-term immunogenicity of the two-dose heterologous Ad26.ZEBOV and MVA-BN-Filo Ebola vaccine regimen in adults in Sierra Leone: a combined open-label, non-randomised stage 1, and a randomised, double-blind, controlled stage 2 trial

Author: Kargbo, M, Bockarie, E, James, N L, Kabbah, A, Kamara, A, Koroma, K H, Langley, S O, William, N, Kessebeh, R, Mooney, T, Conteh, L, Smout, E, Allieu, K, Bangura, K, Bangura, M S, Bangura, M A, Jalloh, H, Jalloh, A B, Kamara, I, Kamara, M, Konteh, A, Koroma, S, Marrah, C, Sesay, M, Sesay, M T, Deen, A T, Jalloh, A, Kaimbay, R M, Kain, D, Kamara, E L, Kamara, M P, Kamara, O J, Kamara, S L M, Kanneh, M, Koroma, A H, Lahai, D, Mansaray, I S, Marah, W S, Massaquoi, M J, Nabie, A, Saidu, N S, Samai, I, Tengheh, J N, Turay, A S, Fornah, A, Sesay, F, Sow, A, Swaray, E, Mansaray, F, Ade-Cole, T, Bangura, L M, Conteh, M L, Koroma, A M, Koroma, M, Sam, A, Scott, T, Sessie, T, Sunders, J-H C, Turay, S I-S, Weekes, J, Sheku, M, Gibson, L, Kowuor, D, Ahamed, I, Allieu, W, Kabba, D U, Kamara, F J, Kebbie, M S, Pessima, M, Wurie, A, Bah, F, Bangura, A I, Bangura, R A S, Blango, L, Boima, S, Conteh, M, Conteh, Y, Daramy, M L, Fofanah, O, George, E, Hanson, T F, Jalloh, M I, Kalawa, M, Kamara, A M, Kamara, F E, Kamara, G M, Kamara, H M, Kamara, P B D, Kamara, R T, Kamara, R, Kanneh, D P, Komeh, I, Kuyateh, M, Mansaray, F F, Mansaray, M M, Sillah, A B, Tarawally, M A, Turya, O S, Yawmah, J B, Leigh, B, Watson-Jones, D, Greenwood, B, Samai, M H, Deen, G F, Marke, D, Piot, P, Smith, P, Edmunds, J, Lees, S, Larson, H, Weiss, H, Wilson, P, Maxwell, C, Ishola, D, Afolabi, M, Baiden, F, Akoo, P, Owusu-Kyei, K, Tindanbil, D, Bower, H, Stuart, J, Bah, O M, Rogers, B T, Serry-Bangura, A, Swaray, I B, Bangura, A, David, I J, Davies, D G M, Kallon, J A, Kamara, A B, Kamara, I F, Kamara, M M, Morovia, F E, Suma, F B, Thompson, F, Murray, M, Sesay, I, Kakay, O, Suma, F, Foster, J, Philips, R, Manno, D, Gallager, K, Cox, S, Howard, N, Cesay, M, Torrani, P, Sharma, S, Snowden, E, Banks, T, Harber, T, Brown, J, Howard, K, Melton, N, Malcolm, S, Welsh, S, Eggo, R, Jendrossek, M, Pearson, C, Van Hoof, J, Douoguih, M, Offergelt, K, Robinson, C, Keshinro, B, Van Alst, M, Mahajan, N, Bockstal, V, Goldstein, N, Gaddah, A, Heerwegh, D, Luhn, K, Leyssen, M, Lowe, B, Awuondo, K, Hafezi, H, Hancox, E, Kohn, B, Tuda, G O, Koroma, F, Bangura, G, Kroma, M T, Fofanah, L, Pessima, A, Rogers, M, Sheriff, O, Ajala, T W, Fangawa, J, Foday Jr, S, Jabbie, I, Mansaray, B, Mansaray, H A, Sesay, K, Charles, M K, Heroe, P C, Karbo, M L, Yansaneh, IS, Egoeh, S G, Trye, A, Amponsah, M, Alghali, N D, Bah, A, Bangura, IJ, Cole, A C, Fofanah, K, Fofanah, S, Jalloh, H U, Jalloh, K F N, Jalloh, N, Kabba, H U, Kabba, J N, Kabba, M, Kamara, J S, Kanjie, F, Kanu, A P, Kargbo, I, Kassa-Koroma, G, Koroma, S B, Sankoh, A, Sankoh, T, Sesay, O D, Wilhem, H, Williams, C T, Bangura, I, Ben-Rogers, Y, Jamboria, F J, Kamara, N, Kanawah, I, Kargbo, A T, Swaray, I, Amara, L, Bundu, I, Jakema, H B, Kamara, K, Sheku, M F, Adeleye, Q, Akhigbe, I, Bakalemwa, R, Chami, N P, Sylvester, T, Altmann, L, Kamara, B, van Roey, K, Conteh, P, Samura, M, Gandie, V, Marrah, M, Moinina, E, Kalokoh, J, Bangura, M I, Bosompem, S, Hilton, T, Jusu, M O, Borboh, P, Brima, A S, Caulker, A F Y, Kallon, A, Koroma, B, Macauley, RC, Saquee, T M D, Williams, H I, Bangura, A R, Fornah, J, Idriss, B, Sillah, M, Mackay, W, Aleghen, B, Murray, T, Edem-Hotah, J, Fatorma, T, Amara, F, Bangura, S, Bonnie, E, Sannoh, M, Donaldson, A, Ndingi, S, Nyaberi, D, Pereira, M, Rothwell, A, Vy, V, Nyallay, L, Fombah, A, Saidu, S, Connor, N, Dambo, T P, Fakaba, P J, Fatorma, M M E, Johnson, C L, Kogba, D B, Lahai, A, Vincent, W, Yambasu, N, Bangura, M, Tengbeh, A, Kabia, R, Nyakoi, AM, Callaghan, M, Enria, L, Lee, S, Ishola, David, Manno, Daniela, Afolabi, Muhammed O, Keshinro, Babajide, Bockstal, Viki, Rogers, Baimba, Owusu-Kyei, Kwabena, Serry-Bangura, Alimamy, Swaray, Ibrahim, Lowe, Brett, Kowuor, Dickens, Baiden, Frank, Mooney, Thomas, Smout, Elizabeth, Köhn, Brian, Otieno, Godfrey T, Jusu, Morrison, Foster, Julie, Samai, Mohamed, Deen, Gibrilla Fadlu, Larson, Heidi, Lees, Shelley, Goldstein, Neil, Gallagher, Katherine E, Gaddah, Auguste, Heerwegh, Dirk, Callendret, Benoit, Luhn, Kerstin, Robinson, Cynthia, Leyssen, Maarten, Greenwood, Brian, Douoguih, Macaya, Leigh, Bailah, and Watson-Jones, Deborah
Published: 2022
Full Text: View/download PDF

5. Helminth exposure and immune response to the two-dose heterologous Ad26.ZEBOV, MVA-BN-Filo Ebola vaccine regimen

Author: Barry, Houreratou, primary, Lhomme, Edouard, additional, Surénaud, Mathieu, additional, Nouctara, Moumini, additional, Robinson, Cynthia, additional, Bockstal, Viki, additional, Valea, Innocent, additional, Somda, Serge, additional, Tinto, Halidou, additional, Meda, Nicolas, additional, Greenwood, Brian, additional, Thiébaut, Rodolphe, additional, and Lacabaratz, Christine, additional
Published: 2024
Full Text: View/download PDF

6. Safety and immunogenicity of a two-dose heterologous Ad26.ZEBOV and MVA-BN-Filo Ebola vaccine regimen in adults in Europe (EBOVAC2): a randomised, observer-blind, participant-blind, placebo-controlled, phase 2 trial

Author: McShane, Christopher, Callendret, Benoit, Dincq, Stephanie, Ferrault, Camille, Chai, Siew Pin, Gyselen, Maire Paule, van Looveren, Marleen, van Ballert, Sylvia, de Cnodder, Tinne, Roza, Len, Forcheh, Chiara, Stevens, Kate, Mastrandrea, Carmela, de Ridder, Sanne, Gundluru, Rachana, Swales, Nathalie, Errijegers, Vanessa, Willems, Wouter, Roorda, Veronika, Orzabal, Nicola, Assenberg, Magdalena, Vialatte, Karine, Remblier, Frédéric, Porcar, Elodie, Ottavi, Anton, Destandau, Eugénie, Schwimmer, Christine, Moinot, Laetitia, Wallet, Cédrick, Allais, Florence, Savel, Hélène, Nedjaai, Naouel, Maugard, Anaïs, Lenzi, Nehza, Loulergue, Pierre, Bahuaud, Mathilde, Lainé, Fabrice, Laviolle, Bruno, Boissel, Nolwenn, Thébault, Elise, Vallée, David, Nicolas, Jean-François, Gilbert, Sophie, Dahel, Karima, Sagorny, Karen, Lucht, Frédéric, Paul, Stéphane, Haccourt Chanavat, Alice, Charra, Florent, Mutter, Catherine, Lambour, Monique, Muller, Caroline, Hutt-Clauss, Anne, Aranda, Olivia, Bernard, Louis, Gissot, Valérie, Hallouin-Bernard, Marie-Charlotte, Goudeau, Alain, Suzzoni, Steve, Auostin, Eva, Brick, Lysiane, Lopez-Zaragoza, Jose-Luis, Melic, Giovanna, Carvalho, Murial, Chesnel, Chrystel, Hocini, Hakim, Wiedemann, Aurélie, Hanot, Laurent, Rieux, Véronique, Puri, Adeep, Adeloye, Temitope, Boyce, Malcolm, Dennison, Jeremy, Loewenstein, Inge, Sahgal, Omar, van den Berg, Frans, Calvert, Wendy, Faldon, Mary, McClain, Bruce, Newell, Marie-Lousie, Molenberghs, Geert, Pollard, Andrew J, Launay, Odile, Lelievre, Jean-Daniel, Lacabaratz, Christine, Grande, Sophie, Goldstein, Neil, Robinson, Cynthia, Gaddah, Auguste, Bockstal, Viki, Wiedemann, Aurelie, Leyssen, Maarten, Luhn, Kerstin, Richert, Laura, Bétard, Christine, Gibani, Malick M, Clutterbuck, Elizabeth A, Snape, Matthew D, Levy, Yves, Douoguih, Macaya, and Thiebaut, Rodolphe
Published: 2021
Full Text: View/download PDF

7. Assessments of different batches and dose levels of a two-dose Ad26.ZEBOV and MVA-BN-Filo vaccine regimen

Author: Bockstal, Viki, Gaddah, Auguste, Goldstein, Neil, Shukarev, Georgi, Bart, Stephan, Luhn, Kerstin, Robinson, Cynthia, Anumendem, Dickson, Leyssen, Maarten, and Douoguih, Macaya
Published: 2021
Full Text: View/download PDF

8. Durable natural killer cell responses after heterologous two-dose Ebola vaccination

Author: Wagstaffe, Helen R., Susannini, Giada, Thiébaut, Rodolphe, Richert, Laura, Lévy, Yves, Bockstal, Viki, Stoop, Jeroen N., Luhn, Kerstin, Douoguih, Macaya, Riley, Eleanor M., Lacabaratz, Christine, and Goodier, Martin R.
Published: 2021
Full Text: View/download PDF

9. Ebola virus glycoprotein stimulates IL-18-dependent natural killer cell responses

Author: Wagstaffe, Helen R., Clutterbuck, Elizabeth A., Bockstal, Viki, Stoop, Jeroen N., Luhn, Kerstin, Douoguih, Macaya, Shukarev, Georgi, Snape, Matthew D., Pollard, Andrew J., Riley, Eleanor M., and Goodier, Martin R.
Subjects: United Kingdom. National Institute for Health Research -- Analysis, Becton, Dickinson and Co., Medical research -- Analysis -- Health aspects, Adenoviruses -- Health aspects -- Analysis, Vaccines -- Health aspects -- Analysis, Killer cells -- Analysis -- Health aspects, Cytokines -- Health aspects -- Analysis, Marburg virus disease -- Prevention, Ebola virus -- Health aspects -- Analysis, Medical equipment industry -- Health aspects -- Analysis, Virus diseases -- Prevention, Infection -- Prevention, Vaccination -- Health aspects -- Analysis, Antibodies -- Analysis -- Health aspects, Immune response -- Health aspects -- Analysis, T cells -- Health aspects -- Analysis, Health care industry
Abstract: BACKGROUND. NK cells are activated by innate cytokines and viral ligands to kill virus-infected cells. These functions are enhanced during secondary immune responses and after vaccination by synergy with effector T cells and virus-specific antibodies. In human Ebola virus infection, clinical outcome is strongly associated with the initial innate cytokine response, but the role of NK cells has not been thoroughly examined. METHODS. The novel 2-dose heterologous Adenovirus type 26.ZEBOV (Ad26.ZEBOV) and modified vaccinia Ankara-BN-Filo (MVA-BN-Filo) vaccine regimen is safe and provides specific immunity against Ebola glycoprotein, and is currently in phase 2 and 3 studies. Here, we analyzed NK cell phenotype and function in response to Ad26.ZEBOV, MVA-BN-Filo vaccination regimen and in response to in vitro Ebola glycoprotein stimulation of PBMCs isolated before and after vaccination. RESULTS. We show enhanced NK cell proliferation and activation after vaccination compared with baseline. Ebola glycoprotein-induced activation of NK cells was dependent on accessory cells and TLR-4-dependent innate cytokine secretion (predominantly from [CD14.sup.+] monocytes) and enriched within less differentiated NK cell subsets. Optimal NK cell responses were dependent on IL-18 and IL-12, whereas IFN-[gamma] secretion was restricted by high concentrations of IL-10. CONCLUSION. This study demonstrates the induction of NK cell effector functions early after Ad26.ZEBOV, MVA-BN-Filo vaccination and provides a mechanism for the activation and regulation of NK cells by Ebola glycoprotein. TRIAL REGISTRATION. ClinicalTrials.gov NCT02313077. FUNDING. United Kingdom Medical Research Council Studentship in Vaccine Research, Innovative Medicines Initiative 2 Joint Undertaking, EBOVAC (grant 115861) and Crucell Holland (now Janssen Vaccines and Prevention B.V.), European Union's Horizon 2020 research and innovation programme and European Federation of Pharmaceutical Industries and Associations (EFPIA)., Introduction Ebola virus infection causes a rapid-onset severe acute hemorrhagic fever (Ebola virus disease, EVD) with mortality ranging from 25% to 90% depending on the outbreak (1). Clinical development of [...]
Published: 2020
Full Text: View/download PDF

10. Safety and immunogenicity of 2-dose heterologous Ad26.ZEBOV, MVA-BN-Filo Ebola vaccination in children and adolescents in Africa: A randomised, placebo-controlled, multicentre Phase II clinical trial

Author: Anywaine, Zacchaeus, Barry, Houreratou, Anzala, Omu, Mutua, Gaudensia, Sirima, Sodiomon B., Eholie, Serge, Kibuuka, Hannah, Bétard, Christine, Richert, Laura, Lacabaratz, Christine, McElrath, M. Juliana, De Rosa, Stephen C., Cohen, Kristen W., Shukarev, Georgi, Katwere, Michael, Robinson, Cynthia, Gaddah, Auguste, Heerwegh, Dirk, Bockstal, Viki, Luhn, Kerstin, Leyssen, Maarten, Thiébaut, Rodolphe, and Douoguih, Macaya
Subjects: Immunogenetics -- Methods, Ebola virus infections -- Risk factors -- Diagnosis -- Care and treatment, Immune response -- Analysis, Ebola virus -- Identification and classification -- Control -- Prevention, Biological sciences
Abstract: Background Reoccurring Ebola outbreaks in West and Central Africa have led to serious illness and death in thousands of adults and children. The objective of this study was to assess safety, tolerability, and immunogenicity of the heterologous 2-dose Ad26.ZEBOV, MVA-BN-Filo vaccination regimen in adolescents and children in Africa. Methods and findings In this multicentre, randomised, observer-blind, placebo-controlled Phase II study, 131 adolescents (12 to 17 years old) and 132 children (4 to 11 years old) were enrolled from Eastern and Western Africa and randomised 5:1 to receive study vaccines or placebo. Vaccine groups received intramuscular injections of Ad26.ZEBOV (5 x 10.sup.10 viral particles) and MVA-BN-Filo (1 x 10.sup.8 infectious units) 28 or 56 days apart; placebo recipients received saline. Primary outcomes were safety and tolerability. Solicited adverse events (AEs) were recorded until 7 days after each vaccination and serious AEs (SAEs) throughout the study. Secondary and exploratory outcomes were humoral immune responses (binding and neutralising Ebola virus [EBOV] glycoprotein [GP]-specific antibodies), up to 1 year after the first dose. Enrolment began on February 26, 2016, and the date of last participant last visit was November 28, 2018. Of the 263 participants enrolled, 217 (109 adolescents, 108 children) received the 2-dose regimen, and 43 (20 adolescents, 23 children) received 2 placebo doses. Median age was 14.0 (range 11 to 17) and 7.0 (range 4 to 11) years for adolescents and children, respectively. Fifty-four percent of the adolescents and 51% of the children were male. All participants were Africans, and, although there was a slight male preponderance overall, the groups were well balanced. No vaccine-related SAEs were reported; solicited AEs were mostly mild/moderate. Twenty-one days post-MVA-BN-Filo vaccination, binding antibody responses against EBOV GP were observed in 100% of vaccinees (106 adolescents, 104 children). Geometric mean concentrations tended to be higher after the 56-day interval (adolescents 13,532 ELISA units [EU]/mL, children 17,388 EU/mL) than the 28-day interval (adolescents 6,993 EU/mL, children 8,007 EU/mL). Humoral responses persisted at least up to Day 365. A limitation of the study is that the follow-up period was limited to 365 days for the majority of the participants, and so it was not possible to determine whether immune responses persisted beyond this time period. Additionally, formal statistical comparisons were not preplanned but were only performed post hoc. Conclusions The heterologous 2-dose vaccination was well tolerated in African adolescents and children with no vaccine-related SAEs. All vaccinees displayed anti-EBOV GP antibodies after the 2-dose regimen, with higher responses in the 56-day interval groups. The frequency of pyrexia after vaccine or placebo was higher in children than in adolescents. These data supported the prophylactic indication against EBOV disease in a paediatric population, as licenced in the EU. Trial registration ClinicalTrials.gov NCT02564523., Author(s): Zacchaeus Anywaine 1, Houreratou Barry 2, Omu Anzala 3, Gaudensia Mutua 3, Sodiomon B. Sirima 4, Serge Eholie 5, Hannah Kibuuka 6, Christine Bétard 7, Laura Richert 7,8, Christine [...]
Published: 2022
Full Text: View/download PDF

11. Nonhuman primate to human immunobridging to infer the protective effect of an Ebola virus vaccine candidate

Author: Roozendaal, Ramon, Hendriks, Jenny, van Effelterre, Thierry, Spiessens, Bart, Dekking, Liesbeth, Solforosi, Laura, Czapska-Casey, Dominika, Bockstal, Viki, Stoop, Jeroen, Splinter, Daniel, Janssen, Sarah, Baelen, Ben van, Verbruggen, Nadia, Serroyen, Jan, Dekeyster, Eline, Volkmann, Ariane, Wollmann, Yvonne, Carrion, Jr., Ricardo, Giavedoni, Luis D., Robinson, Cynthia, Leyssen, Maarten, Douoguih, Macaya, Luhn, Kerstin, Pau, Maria Grazia, Sadoff, Jerry, Vandebosch, An, Schuitemaker, Hanneke, Zahn, Roland, and Callendret, Benoit
Published: 2020
Full Text: View/download PDF

12. Safety and immunogenicity of 2-dose heterologous Ad26.ZEBOV, MVA-BN-Filo Ebola vaccination in healthy and HIV-infected adults: A randomised, placebo-controlled Phase II clinical trial in Africa

Author: Barry, Houreratou, Mutua, Gaudensia, Kibuuka, Hannah, Anywaine, Zacchaeus, Sirima, Sodiomon B., Meda, Nicolas, Anzala, Omu, Eholie, Serge, Bétard, Christine, Richert, Laura, Lacabaratz, Christine, McElrath, M. Juliana, De Rosa, Stephen, Cohen, Kristen W., Shukarev, Georgi, Robinson, Cynthia, Gaddah, Auguste, Heerwegh, Dirk, Bockstal, Viki, Luhn, Kerstin, Leyssen, Maarten, Douoguih, Macaya, and Thiébaut, Rodolphe
Subjects: HIV patients -- Patient outcomes, Biological sciences
Abstract: Background We investigated safety, tolerability, and immunogenicity of the heterologous 2-dose Ebola vaccination regimen in healthy and HIV-infected adults with different intervals between Ebola vaccinations. Methods and findings In this randomised, observer-blind, placebo-controlled Phase II trial, 668 healthy 18- to 70-year-olds and 142 HIV-infected 18- to 50-year-olds were enrolled from 1 site in Kenya and 2 sites each in Burkina Faso, Cote d'Ivoire, and Uganda. Participants received intramuscular Ad26.ZEBOV followed by MVA-BN-Filo at 28-, 56-, or 84-day intervals, or saline. Females represented 31.4% of the healthy adult cohort in contrast to 69.7% of the HIV-infected cohort. A subset of healthy adults received booster vaccination with Ad26.ZEBOV or saline at Day 365. Following vaccinations, adverse events (AEs) were collected until 42 days post last vaccination and serious AEs (SAEs) were recorded from signing of the ICF until the end of the study. The primary endpoint was safety, and the secondary endpoint was immunogenicity. Anti-Ebola virus glycoprotein (EBOV GP) binding and neutralising antibodies were measured at baseline and at predefined time points throughout the study. The first participant was enrolled on 9 November 2015, and the date of last participant's last visit was 12 February 2019. No vaccine-related SAEs and mainly mild-to-moderate AEs were observed among the participants. The most frequent solicited AEs were injection-site pain (local), and fatigue, headache, and myalgia (systemic), respectively. Twenty-one days post-MVA-BN-Filo vaccination, geometric mean concentrations (GMCs) with 95% confidence intervals (CIs) of EBOV GP binding antibodies in healthy adults in 28-, 56-, and 84-day interval groups were 3,085 EU/mL (2,648 to 3,594), 7,518 EU/mL (6,468 to 8,740), and 7,300 EU/mL (5,116 to 10,417), respectively. In HIV-infected adults in 28- and 56-day interval groups, GMCs were 4,207 EU/mL (3,233 to 5,474) and 5,283 EU/mL (4,094 to 6,817), respectively. Antibody responses were observed until Day 365. Ad26.ZEBOV booster vaccination after 1 year induced an anamnestic response. Study limitations include that some healthy adult participants either did not receive dose 2 or received dose 2 outside of their protocol-defined interval and that the follow-up period was limited to 365 days for most participants. Conclusions Ad26.ZEBOV, MVA-BN-Filo vaccination was well tolerated and immunogenic in healthy and HIV-infected African adults. Increasing the interval between vaccinations from 28 to 56 days improved the magnitude of humoral immune responses. Antibody levels persisted to at least 1 year, and Ad26.ZEBOV booster vaccination demonstrated the presence of vaccination-induced immune memory. These data supported the approval by the European Union for prophylaxis against EBOV disease in adults and children [greater than or equal to]1 year of age. Trial registration ClinicalTrials.gov NCT02564523, Author(s): Houreratou Barry 1, Gaudensia Mutua 2, Hannah Kibuuka 3, Zacchaeus Anywaine 4, Sodiomon B. Sirima 5, Nicolas Meda 1, Omu Anzala 2, Serge Eholie 6, Christine Bétard 7, Laura [...]
Published: 2021
Full Text: View/download PDF

13. Ultrapotent SARS coronavirus-neutralizing single-domain antibodies that bind a conserved membrane proximal epitope of the spike

Author: De Cae, Sieglinde, primary, Van Molle, Inge, additional, van Schie, Loes, additional, Shoemaker, Sophie R, additional, Deckers, Julie, additional, Debeuf, Nincy, additional, Lameire, Sahine, additional, Nerinckx, Wim, additional, Roose, Kenny, additional, Fijalkowska, Daria, additional, Devos, Simon, additional, Desmet, Anne-Sophie, additional, Zavala Marchan, Jackeline Cecilia, additional, Venneman, Toon, additional, Ghassabeh, Gholamreza Hassanzadeh, additional, Sedeyn, Koen, additional, Ballegeer, Marlies, additional, Vanheerswynghels, Manon, additional, De Wolf, Caroline, additional, Demol, Hans, additional, Vanhaverbeke, Pieter, additional, Lonigro, Chiara, additional, Bockstal, Viki, additional, Rinaldi, Manuela, additional, Abdelnabi, Rana, additional, Neyts, Johan, additional, Marqusee, Susan, additional, Lambrecht, Bart N, additional, Callewaert, Nico, additional, Remaut, Han, additional, Saelens, Xavier, additional, and Schepens, Bert, additional
Published: 2023
Full Text: View/download PDF

14. First-in-human study to evaluate safety, tolerability, and immunogenicity of heterologous regimens using the multivalent filovirus vaccines Ad26.Filo and MVA-BN-Filo administered in different sequences and schedules: A randomized, controlled study

Author: Bockstal, Viki, primary, Shukarev, Georgi, additional, McLean, Chelsea, additional, Goldstein, Neil, additional, Bart, Stephan, additional, Gaddah, Auguste, additional, Anumenden, Dickson, additional, Stoop, Jeroen N., additional, Marit de Groot, Anne, additional, Pau, Maria G., additional, Hendriks, Jenny, additional, De Rosa, Stephen C., additional, Cohen, Kristen W., additional, McElrath, M. Juliana, additional, Callendret, Benoit, additional, Luhn, Kerstin, additional, Douoguih, Macaya, additional, and Robinson, Cynthia, additional
Published: 2022
Full Text: View/download PDF

15. NK Cell Subset Redistribution and Antibody Dependent Activation after Ebola Vaccination in Africans

Author: Wagstaffe, Helen R., primary, Anzala, Omu, additional, Kibuuka, Hannah, additional, Anywaine, Zacchaeus, additional, Sirima, Sodiomon B., additional, Thiébaut, Rodolphe, additional, Richert, Laura, additional, Levy, Yves, additional, Lacabaratz, Christine, additional, Bockstal, Viki, additional, Luhn, Kerstin, additional, Douoguih, Macaya, additional, and Goodier, Martin R., additional
Published: 2022
Full Text: View/download PDF

16. Safety and long-term immunogenicity of the two-dose heterologous Ad26.ZEBOV and MVA-BN-Filo Ebola vaccine regimen in adults in Sierra Leone: a combined open-label, non-randomised stage 1, and a randomised, double-blind, controlled stage 2 trial

Author: Ishola, David, primary, Manno, Daniela, additional, Afolabi, Muhammed O, additional, Keshinro, Babajide, additional, Bockstal, Viki, additional, Rogers, Baimba, additional, Owusu-Kyei, Kwabena, additional, Serry-Bangura, Alimamy, additional, Swaray, Ibrahim, additional, Lowe, Brett, additional, Kowuor, Dickens, additional, Baiden, Frank, additional, Mooney, Thomas, additional, Smout, Elizabeth, additional, Köhn, Brian, additional, Otieno, Godfrey T, additional, Jusu, Morrison, additional, Foster, Julie, additional, Samai, Mohamed, additional, Deen, Gibrilla Fadlu, additional, Larson, Heidi, additional, Lees, Shelley, additional, Goldstein, Neil, additional, Gallagher, Katherine E, additional, Gaddah, Auguste, additional, Heerwegh, Dirk, additional, Callendret, Benoit, additional, Luhn, Kerstin, additional, Robinson, Cynthia, additional, Leyssen, Maarten, additional, Greenwood, Brian, additional, Douoguih, Macaya, additional, Leigh, Bailah, additional, Watson-Jones, Deborah, additional, Kargbo, M, additional, Bockarie, E, additional, James, N L, additional, Kabbah, A, additional, Kamara, A, additional, Koroma, K H, additional, Langley, S O, additional, William, N, additional, Kessebeh, R, additional, Mooney, T, additional, Conteh, L, additional, Smout, E, additional, Allieu, K, additional, Bangura, K, additional, Bangura, M S, additional, Bangura, M A, additional, Jalloh, H, additional, Jalloh, A B, additional, Kamara, I, additional, Kamara, M, additional, Konteh, A, additional, Koroma, S, additional, Marrah, C, additional, Sesay, M, additional, Sesay, M T, additional, Deen, A T, additional, Jalloh, A, additional, Kaimbay, R M, additional, Kain, D, additional, Kamara, E L, additional, Kamara, M P, additional, Kamara, O J, additional, Kamara, S L M, additional, Kanneh, M, additional, Koroma, A H, additional, Lahai, D, additional, Mansaray, I S, additional, Marah, W S, additional, Massaquoi, M J, additional, Nabie, A, additional, Saidu, N S, additional, Samai, I, additional, Tengheh, J N, additional, Turay, A S, additional, Fornah, A, additional, Sesay, F, additional, Sow, A, additional, Swaray, E, additional, Mansaray, F, additional, Ade-Cole, T, additional, Bangura, L M, additional, Conteh, M L, additional, Koroma, A M, additional, Koroma, M, additional, Sam, A, additional, Scott, T, additional, Sessie, T, additional, Sunders, J-H C, additional, Turay, S I-S, additional, Weekes, J, additional, Sheku, M, additional, Gibson, L, additional, Kowuor, D, additional, Ahamed, I, additional, Allieu, W, additional, Kabba, D U, additional, Kamara, F J, additional, Kebbie, M S, additional, Pessima, M, additional, Wurie, A, additional, Bah, F, additional, Bangura, A I, additional, Bangura, R A S, additional, Blango, L, additional, Boima, S, additional, Conteh, M, additional, Conteh, Y, additional, Daramy, M L, additional, Fofanah, O, additional, George, E, additional, Hanson, T F, additional, Jalloh, M I, additional, Kalawa, M, additional, Kamara, A M, additional, Kamara, F E, additional, Kamara, G M, additional, Kamara, H M, additional, Kamara, P B D, additional, Kamara, R T, additional, Kamara, R, additional, Kanneh, D P, additional, Komeh, I, additional, Kuyateh, M, additional, Mansaray, F F, additional, Mansaray, M M, additional, Sillah, A B, additional, Tarawally, M A, additional, Turya, O S, additional, Yawmah, J B, additional, Leigh, B, additional, Watson-Jones, D, additional, Greenwood, B, additional, Samai, M H, additional, Deen, G F, additional, Marke, D, additional, Piot, P, additional, Smith, P, additional, Edmunds, J, additional, Lees, S, additional, Larson, H, additional, Weiss, H, additional, Wilson, P, additional, Maxwell, C, additional, Ishola, D, additional, Afolabi, M, additional, Baiden, F, additional, Akoo, P, additional, Owusu-Kyei, K, additional, Tindanbil, D, additional, Bower, H, additional, Stuart, J, additional, Bah, O M, additional, Rogers, B T, additional, Serry-Bangura, A, additional, Swaray, I B, additional, Bangura, A, additional, David, I J, additional, Davies, D G M, additional, Kallon, J A, additional, Kamara, A B, additional, Kamara, I F, additional, Kamara, M M, additional, Morovia, F E, additional, Suma, F B, additional, Thompson, F, additional, Murray, M, additional, Sesay, I, additional, Kakay, O, additional, Suma, F, additional, Foster, J, additional, Philips, R, additional, Manno, D, additional, Gallager, K, additional, Cox, S, additional, Howard, N, additional, Cesay, M, additional, Torrani, P, additional, Sharma, S, additional, Snowden, E, additional, Banks, T, additional, Harber, T, additional, Brown, J, additional, Howard, K, additional, Melton, N, additional, Malcolm, S, additional, Welsh, S, additional, Eggo, R, additional, Jendrossek, M, additional, Pearson, C, additional, Van Hoof, J, additional, Douoguih, M, additional, Offergelt, K, additional, Robinson, C, additional, Keshinro, B, additional, Van Alst, M, additional, Mahajan, N, additional, Bockstal, V, additional, Goldstein, N, additional, Gaddah, A, additional, Heerwegh, D, additional, Luhn, K, additional, Leyssen, M, additional, Lowe, B, additional, Awuondo, K, additional, Hafezi, H, additional, Hancox, E, additional, Kohn, B, additional, Tuda, G O, additional, Koroma, F, additional, Bangura, G, additional, Kroma, M T, additional, Fofanah, L, additional, Pessima, A, additional, Rogers, M, additional, Sheriff, O, additional, Ajala, T W, additional, Fangawa, J, additional, Foday Jr, S, additional, Jabbie, I, additional, Mansaray, B, additional, Mansaray, H A, additional, Sesay, K, additional, Charles, M K, additional, Heroe, P C, additional, Karbo, M L, additional, Yansaneh, IS, additional, Egoeh, S G, additional, Trye, A, additional, Amponsah, M, additional, Alghali, N D, additional, Bah, A, additional, Bangura, IJ, additional, Cole, A C, additional, Fofanah, K, additional, Fofanah, S, additional, Jalloh, H U, additional, Jalloh, K F N, additional, Jalloh, N, additional, Kabba, H U, additional, Kabba, J N, additional, Kabba, M, additional, Kamara, J S, additional, Kanjie, F, additional, Kanu, A P, additional, Kargbo, I, additional, Kassa-Koroma, G, additional, Koroma, S B, additional, Sankoh, A, additional, Sankoh, T, additional, Sesay, O D, additional, Wilhem, H, additional, Williams, C T, additional, Bangura, I, additional, Ben-Rogers, Y, additional, Jamboria, F J, additional, Kamara, N, additional, Kanawah, I, additional, Kargbo, A T, additional, Swaray, I, additional, Amara, L, additional, Bundu, I, additional, Jakema, H B, additional, Kamara, K, additional, Sheku, M F, additional, Adeleye, Q, additional, Akhigbe, I, additional, Bakalemwa, R, additional, Chami, N P, additional, Sylvester, T, additional, Altmann, L, additional, Kamara, B, additional, van Roey, K, additional, Conteh, P, additional, Samura, M, additional, Gandie, V, additional, Marrah, M, additional, Moinina, E, additional, Kalokoh, J, additional, Bangura, M I, additional, Bosompem, S, additional, Hilton, T, additional, Jusu, M O, additional, Borboh, P, additional, Brima, A S, additional, Caulker, A F Y, additional, Kallon, A, additional, Koroma, B, additional, Macauley, RC, additional, Saquee, T M D, additional, Williams, H I, additional, Bangura, A R, additional, Fornah, J, additional, Idriss, B, additional, Sillah, M, additional, Mackay, W, additional, Aleghen, B, additional, Murray, T, additional, Edem-Hotah, J, additional, Fatorma, T, additional, Amara, F, additional, Bangura, S, additional, Bonnie, E, additional, Sannoh, M, additional, Donaldson, A, additional, Ndingi, S, additional, Nyaberi, D, additional, Pereira, M, additional, Rothwell, A, additional, Vy, V, additional, Nyallay, L, additional, Fombah, A, additional, Saidu, S, additional, Connor, N, additional, Dambo, T P, additional, Fakaba, P J, additional, Fatorma, M M E, additional, Johnson, C L, additional, Kogba, D B, additional, Lahai, A, additional, Vincent, W, additional, Yambasu, N, additional, Bangura, M, additional, Tengbeh, A, additional, Kabia, R, additional, Nyakoi, AM, additional, Callaghan, M, additional, Enria, L, additional, and Lee, S, additional
Published: 2022
Full Text: View/download PDF

17. Safety and immunogenicity of the two-dose heterologous Ad26.ZEBOV and MVA-BN-Filo Ebola vaccine regimen in children in Sierra Leone: a randomised, double-blind, controlled trial

Author: Afolabi, Muhammed O, primary, Ishola, David, additional, Manno, Daniela, additional, Keshinro, Babajide, additional, Bockstal, Viki, additional, Rogers, Baimba, additional, Owusu-Kyei, Kwabena, additional, Serry-Bangura, Alimamy, additional, Swaray, Ibrahim, additional, Lowe, Brett, additional, Kowuor, Dickens, additional, Baiden, Frank, additional, Mooney, Thomas, additional, Smout, Elizabeth, additional, Köhn, Brian, additional, Otieno, Godfrey T, additional, Jusu, Morrison, additional, Foster, Julie, additional, Samai, Mohamed, additional, Deen, Gibrilla Fadlu, additional, Larson, Heidi, additional, Lees, Shelley, additional, Goldstein, Neil, additional, Gallagher, Katherine E, additional, Gaddah, Auguste, additional, Heerwegh, Dirk, additional, Callendret, Benoit, additional, Luhn, Kerstin, additional, Robinson, Cynthia, additional, Greenwood, Brian, additional, Leyssen, Maarten, additional, Douoguih, Macaya, additional, Leigh, Bailah, additional, Watson-Jones, Deborah, additional, Kargbo, M, additional, Bockarie, E, additional, James, N L, additional, Kabbah, A, additional, Kamara, A, additional, Koroma, K H, additional, Langley, S O, additional, William, N, additional, Kessebeh, R, additional, Mooney, T, additional, Conteh, L, additional, Smout, E, additional, Allieu, K, additional, Bangura, K, additional, Bangura, M S, additional, Bangura, M A, additional, Jalloh, H, additional, Jalloh, A B, additional, Kamara, I, additional, Kamara, M, additional, Konteh, A, additional, Koroma, S, additional, Marrah, C, additional, Sesay, M, additional, Sesay, M T, additional, Deen, A T, additional, Jalloh, A, additional, Kaimbay, R M, additional, Kain, D, additional, Kamara, E L, additional, Kamara, M P, additional, Kamara, O J, additional, Kamara, S L M, additional, Kanneh, M, additional, Koroma, A H, additional, Lahai, D, additional, Mansaray, I S, additional, Marah, W S, additional, Massaquoi, M J, additional, Nabie, A, additional, Saidu, N S, additional, Samai, I, additional, Tengheh, J N, additional, Turay, A S, additional, Fornah, A, additional, Sesay, F, additional, Sow, A, additional, Swaray, E, additional, Mansaray, F, additional, Ade-Cole, T, additional, Bangura, L M, additional, Conteh, M L, additional, Koroma, A M, additional, Koroma, M, additional, Sam, A, additional, Scott, T, additional, Sessie, T, additional, Sunders, J-H C, additional, Turay, S I-S, additional, Weekes, J, additional, Sheku, M, additional, Gibson, L, additional, Kowuor, D, additional, Ahamed, I, additional, Allieu, W, additional, Kabba, D U, additional, Kamara, F J, additional, Kebbie, M S, additional, Pessima, M, additional, Wurie, A, additional, Bah, F, additional, Bangura, A I, additional, Bangura, R A S, additional, Blango, L, additional, Boima, S, additional, Conteh, M, additional, Conteh, Y, additional, Daramy, M L, additional, Fofanah, O, additional, George, E, additional, Hanson, T F, additional, Jalloh, M I, additional, Kalawa, M, additional, Kamara, A M, additional, Kamara, F E, additional, Kamara, G M, additional, Kamara, H M, additional, Kamara, P B D, additional, Kamara, R T, additional, Kamara, R, additional, Kanneh, D P, additional, Komeh, I, additional, Kuyateh, M, additional, Mansaray, F F, additional, Mansaray, M M, additional, Sillah, A B, additional, Tarawally, M A, additional, Turya, O S, additional, Yawmah, J B, additional, Leigh, B, additional, Watson-Jones, D, additional, Greenwood, B, additional, Samai, M H, additional, Deen, G F, additional, Marke, D, additional, Sesay, T, additional, Piot, P, additional, Smith, P, additional, Edmunds, J, additional, Lees, S, additional, Larson, H, additional, Weiss, H, additional, Wilson, P, additional, Phillips, R, additional, Maxwell, C, additional, Ishola, D, additional, Afolabi, M, additional, Baiden, F, additional, Akoo, P, additional, Owusu-Kyei, K, additional, Tindanbil, D, additional, Bower, H, additional, Stuart, J, additional, Bah, O M, additional, Rogers, B T, additional, Serry-Bangura, A, additional, Swaray, I B, additional, Bangura, A, additional, David, I J, additional, Davies, D G M, additional, Kallon, J A, additional, Kamara, A B, additional, Kamara, I F, additional, Kamara, M M, additional, Morovia, F E, additional, Suma, F B, additional, Thompson, F, additional, Murray, M, additional, Kakay, O, additional, Suma, F, additional, Sesay, I, additional, Foster, J, additional, Manno, D, additional, Gallagher, K, additional, Cox, S, additional, Howard, N, additional, Cesay, M, additional, Torrani, P, additional, Sharma, S, additional, Snowden, E, additional, Banks, T, additional, Harber, T, additional, Brown, J, additional, Howard, K, additional, Melton, N, additional, Malcolm, S, additional, Welsh, S, additional, Eggo, R, additional, Jendrossek, M, additional, Pearson, C, additional, Offergeld, K, additional, Ferrault, C, additional, Van Alst, M, additional, Mahajan, N, additional, Van Looveren, M, additional, Van Ballaert, S, additional, De Cnodder, T, additional, Grobler, N, additional, Roza, L, additional, Liberi, T, additional, Armishaw, L, additional, Verkleij, C, additional, Henrick, T, additional, Banaszkiewicz, A, additional, Lowe, B, additional, Awuondo, K, additional, Hafezi, H, additional, Hancox, E, additional, Kohn, B, additional, Tuda, G O, additional, Bangura, G, additional, Kroma, M T, additional, Fofanah, L, additional, Pessima, A, additional, Rogers, M, additional, Sheriff, O, additional, Ajala, T W, additional, Fangawa, J, additional, Foday Jr, S, additional, Koroma, I S F, additional, Mansaray, B, additional, Mansaray, H A, additional, Sesay, K, additional, Charles, M K, additional, Heroe, P C, additional, Lamin Karbo, M, additional, Yansaneh, I S, additional, Gogo Egoeh, S, additional, Trye, A, additional, Amponsah, M, additional, Donelson, L, additional, Sylvester, T, additional, Owira, V, additional, Onyuka, G, additional, Nambuchi, L, additional, Oburu, A, additional, Apollo, D, additional, Vandi, L, additional, Alghali, N D, additional, Bah, A, additional, Bangura, I J, additional, Cole, A C, additional, Fofanah, S, additional, Jalloh, H U, additional, Jalloh, K F N, additional, Jalloh, N, additional, Kabba, H U, additional, Kabba, J N, additional, Kabba, M, additional, Kamara, J S, additional, Kanjie, F, additional, Kanu, A P, additional, Kargbo, I, additional, Kassa-Koroma, G, additional, Koroma, S B, additional, Sankoh, A, additional, Sankoh, T, additional, Sesay, O D, additional, Wilhem, H, additional, Williams, C T, additional, Bangura, I, additional, Ben-Rogers, Y, additional, Jamboria, F J, additional, Kamara, N, additional, Kanawah, I, additional, Kargbo, A T, additional, Swaray, I, additional, Amara, L, additional, Bundu, I, additional, Jakema, H B, additional, Kamara, K, additional, Sheku, M F, additional, Adeleye, Q, additional, Akhigbe, I, additional, Bakalemwa, R, additional, Chami, N P, additional, Altmann, L, additional, Kamara, B, additional, van Roey, K, additional, Conteh, P, additional, Samura, M, additional, Gandie, V, additional, Marrah, M, additional, Moinina, E, additional, Kalokoh, J, additional, Bosompem, S, additional, Hilton, T, additional, Jusu, M O, additional, Borboh, P, additional, Brima, A S, additional, Caulker, A F Y, additional, Kallon, A, additional, Koroma, B, additional, Macauley, R C, additional, Saquee, T M D, additional, Williams, H I, additional, Bangura, A R, additional, Fornah, J, additional, Idriss, B, additional, Sillah, M, additional, Mackay, W, additional, Aleghen, B, additional, Murray, T, additional, Edem-Hotah, J, additional, Fatorma, T, additional, Amara, F, additional, Bangura, S, additional, Bonnie, E, additional, Sannoh, M, additional, Donaldson, A, additional, Ndingi, S, additional, Nyaberi, D, additional, Pereira, M, additional, Rothwell, A, additional, Vy, V, additional, Nyallay, L, additional, Fombah, A, additional, Saidu, S, additional, Dambo, T P, additional, Fakaba, P J, additional, Fatorma, M M E, additional, Freeman, R H, additional, Johnson, C L, additional, Kogba, D B, additional, Lahai, A, additional, Vincent, W, additional, Yambasu, N, additional, Bangura, M, additional, Tengbeh, A, additional, Kabia, R, additional, Nyakoi, A M, additional, Callaghan, M, additional, Enria, L, additional, and Lee, S, additional
Published: 2022
Full Text: View/download PDF

18. Safety and long-term immunogenicity of the two-dose heterologous Ad26.ZEBOV and MVA-BN-Filo Ebola vaccine regimen in adults in Sierra Leone: a combined open-label, non-randomised stage 1, and a randomised, double-blind, controlled stage 2 trial

Author: Ishola, David, Manno, Daniela, Afolabi, Muhammed O, Keshinro, Babajide, Bockstal, Viki, Rogers, Baimba, Owusu-Kyei, Kwabena, Serry-Bangura, Alimamy, Swaray, Ibrahim, Lowe, Brett, Kowuor, Dickens, Baiden, Frank, Mooney, Thomas, Smout, Elizabeth, Kohn, Brian, Otieno, Godfrey T, Jusu, Morrison, Foster, Julie, Samai, Mohamed, Deen, Gibrilla Fadlu, Larson, Heidi, Lees, Shelley, Goldstein, Neil, Gallagher, Katherine E, Gaddah, Auguste, Heerwegh, Dirk, Callendret, Benoit, Luhn, Kerstin, Robinson, Cynthia, Leyssen, Maarten, Greenwood, Brian, Douoguih, Macaya, Leigh, Bailah, and Watson-Jones, Deborah
Abstract: Background: The Ebola epidemics in west Africa and the Democratic Republic of the Congo highlight an urgent need for safe and effective vaccines to prevent Ebola virus disease. We aimed to assess the safety and long-term immunogenicity of a two-dose heterologous vaccine regimen, comprising the adenovirus type 26 vector-based vaccine encoding the Ebola virus glycoprotein (Ad26.ZEBOV) and the modified vaccinia Ankara vector-based vaccine, encoding glycoproteins from Ebola virus, Sudan virus, and Marburg virus, and the nucleoprotein from the Tai Forest virus (MVA-BN-Filo), in Sierra Leone, a country previously affected by Ebola. Methods: The trial comprised two stages: an open-label, non-randomised stage 1, and a randomised, double-blind, controlled stage 2. The study was done at three clinics in Kambia district, Sierra Leone. In stage 1, healthy adults (aged ≥18 years) residing in or near Kambia district, received an intramuscular injection of Ad26.ZEBOV (5 × 1010 viral particles) on day 1 (first dose) followed by an intramuscular injection of MVA-BN-Filo (1 × 108 infectious units) on day 57 (second dose). An Ad26.ZEBOV booster vaccination was offered at 2 years after the first dose to stage 1 participants. The eligibility criteria for adult participants in stage 2 were consistent with stage 1 eligibility criteria. Stage 2 participants were randomly assigned (3:1), by computer-generated block randomisation (block size of eight) via an interactive web-response system, to receive either the Ebola vaccine regimen (Ad26.ZEBOV followed by MVA-BN-Filo) or an intramuscular injection of a single dose of meningococcal quadrivalent (serogroups A, C, W135, and Y) conjugate vaccine (MenACWY; first dose) followed by placebo on day 57 (second dose; control group). Study team personnel, except those with primary responsibility for study vaccine preparation, and participants were masked to study vaccine allocation. The primary outcome was the safety of the Ad26.ZEBOV and MVA-BN-Filo vaccine regimen, which was assessed in all participants who had received at least one dose of study vaccine. Safety was assessed as solicited local and systemic adverse events occurring in the first 7 days after each vaccination, unsolicited adverse events occurring in the first 28 days after each vaccination, and serious adverse events or immediate reportable events occurring up to each participant's last study visit. Secondary outcomes were to assess Ebola virus glycoprotein-specific binding antibody responses at 21 days after the second vaccine in a per-protocol set of participants (ie, those who had received both vaccinations within the protocol-defined time window, had at least one evaluable post-vaccination sample, and had no major protocol deviations that could have influenced the immune response) and to assess the safety and tolerability of the Ad26.ZEBOV booster vaccination in stage 1 participants who had received the booster dose. This study is registered at ClinicalTrials.gov, NCT02509494. Findings: Between Sept 30, 2015, and Oct 19, 2016, 443 participants (43 in stage 1 and 400 in stage 2) were enrolled; 341 participants assigned to receive the Ad26.ZEBOV and MVA-BN-Filo regimen and 102 participants assigned to receive the MenACWY and placebo regimen received at least one dose of study vaccine. Both regimens were well tolerated with no safety concerns. In stage 1, solicited local adverse events (mostly mild or moderate injection-site pain) were reported in 12 (28%) of 43 participants after Ad26.ZEBOV vaccination and in six (14%) participants after MVA-BN-Filo vaccination. In stage 2, solicited local adverse events were reported in 51 (17%) of 298 participants after Ad26.ZEBOV vaccination, in 58 (24%) of 246 after MVA-BN-Filo vaccination, in 17 (17%) of 102 after MenACWY vaccination, and in eight (9%) of 86 after placebo injection. In stage 1, solicited systemic adverse events were reported in 18 (42%) of 43 participants after Ad26.ZEBOV vaccination and in 17 (40%) after MVA-BN-Filo vaccination. In stage 2, solicited systemic adverse events were reported in 161 (54%) of 298 participants after Ad26.ZEBOV vaccination, in 107 (43%) of 246 after MVA-BN-Filo vaccination, in 51 (50%) of 102 after MenACWY vaccination, and in 39 (45%) of 86 after placebo injection. Solicited systemic adverse events in both stage 1 and 2 participants included mostly mild or moderate headache, myalgia, fatigue, and arthralgia. The most frequent unsolicited adverse event after the first dose was headache in stage 1 and malaria in stage 2. Malaria was the most frequent unsolicited adverse event after the second dose in both stage 1 and 2. No serious adverse event was considered related to the study vaccine, and no immediate reportable events were observed. In stage 1, the safety profile after the booster vaccination was not notably different to that observed after the first dose. Vaccine-induced humoral immune responses were observed in 41 (98%) of 42 stage 1 participants (geometric mean binding antibody concentration 4784 ELISA units [EU]/mL [95% CI 3736–6125]) and in 176 (98%) of 179 stage 2 participants (3810 EU/mL [3312–4383]) at 21 days after the second vaccination. Interpretation: The Ad26.ZEBOV and MVA-BN-Filo vaccine regimen was well tolerated and immunogenic, with persistent humoral immune responses. These data support the use of this vaccine regimen for Ebola virus disease prophylaxis in adults. Funding: Innovative Medicines Initiative 2 Joint Undertaking and Janssen Vaccines & Prevention BV.
Published: 2021

19. NPJ Vaccines

Author: Wagstaffe, Helen R., Susannini, Giada, Thiébaut, Rodolphe, Richert, Laura, Lévy, Yves, Lévy, Yves, Bockstal, Viki, Stoop, Jeroen N., Luhn, Kerstin, Douoguih, Macaya, Riley, Eleanor M, Lacabaratz, Christine, Goodier, Martin R, London School of Hygiene and Tropical Medicine (LSHTM), Statistics In System biology and Translational Medicine (SISTM), Inria Bordeaux - Sud-Ouest, Institut National de Recherche en Informatique et en Automatique (Inria)-Institut National de Recherche en Informatique et en Automatique (Inria)- Bordeaux population health (BPH), Université de Bordeaux (UB)-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Bordeaux (UB)-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Institut National de la Santé et de la Recherche Médicale (INSERM), Bordeaux population health (BPH), Université de Bordeaux (UB)-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Institut National de la Santé et de la Recherche Médicale (INSERM), Vaccine Research Institute (VRI), Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), and Janssen Vaccines & Prevention [Leiden]
Subjects: viruses, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie
Abstract: International audience; Natural killer (NK) cells are implicated among immune effectors after vaccination against viral pathogens, including Ebola virus. The two-dose heterologous Ebola virus vaccine regimen, adenovirus type 26.ZEBOV followed by modified vaccinia Ankara-BN-Filo (EBOVAC2 consortium, EU Innovative Medicines Initiative), induces NK cell activation and anti-Ebola glycoprotein (GP) antibody-dependent NK cell activation post-dose 1, which is further elevated post-dose 2. Here, in a multicentre, phase 2 clinical trial (EBL2001), we demonstrate durable ex vivo NK cell activation 180 days after dose 2, with responses enriched in CD56(bright) NK cells. In vitro antibody-dependent responses to immobilised Ebola GP increased after dose 1, and remained elevated compared to pre-vaccination levels in serum collected 180 days later. Peak NK cell responses were observed post-dose 2 and NK cell IFN-γ responses remained significantly elevated at 180 days post-dose 2. Individual variation in NK cell responses were influenced by both anti-Ebola GP antibody concentrations and intrinsic interindividual differences in NK cell functional capacity. In summary, this study demonstrates durable NK cell responses after Ad26.ZEBOV, MVA-BN-Filo Ebola virus vaccination and could inform the immunological evaluation of future iterations of the vaccine regimen and vaccination schedules.
Published: 2021

20. Safety and Immunogenicity of Heterologous and Homologous 2-Dose Regimens of Adenovirus Serotype 26- and Modified Vaccinia Ankara-Vectored Ebola Vaccines: A Randomized, Controlled Phase 1 Study.

Author: Goldstein, Neil, Bockstal, Viki, Bart, Stephan, Luhn, Kerstin, Robinson, Cynthia, Gaddah, Auguste, Callendret, Benoit, and Douoguih, Macaya
Subjects: *RESEARCH, *VIRAL vaccines, *EBOLA virus disease, *VIRUSES, *CLINICAL trials, *RESEARCH methodology, *EVALUATION research, *EBOLA virus, *SEROTYPES, *COMPARATIVE studies, *RANDOMIZED controlled trials, *POXVIRUS diseases, *VIRAL antibodies
Abstract: Background: This phase 1 placebo-controlled study assessed the safety and immunogenicity of 2-dose regimens of Ad26.ZEBOV (adenovirus serotype 26 [Ad26]) and MVA-BN-Filo (modified vaccinia Ankara [MVA]) vaccines with booster vaccination at day 360.Methods: Healthy US adults (N = 164) randomized into 10 groups received saline placebo or standard or high doses of Ad26 or MVA in 2-dose regimens at 7-, 14-, 28-, or 56-day intervals; 8 groups received booster Ad26 or MVA vaccinations on day 360. Participants reported solicited and unsolicited reactogenicity; we measured immunoglobulin G binding, neutralizing antibodies and cellular immune responses to Ebola virus glycoprotein.Results: All regimens were well tolerated with no serious vaccine-related adverse events. Heterologous (Ad26,MVA [dose 1, dose 2] or MVA,Ad26) and homologous (Ad26,Ad26) regimens induced humoral and cellular immune responses 21 days after dose 2; responses were higher after heterologous regimens. Booster vaccination elicited anamnestic responses in all participants.Conclusions: Both heterologous and homologous Ad26,MVA Ebola vaccine regimens are well tolerated in healthy adults, regardless of interval or dose level. Heterologous 2-dose Ad26,MVA regimens containing an Ebola virus insert induce strong, durable humoral and cellular immune responses. Immunological memory was rapidly recalled by booster vaccination, suggesting that Ad26 booster doses could be considered for individuals at risk of Ebola infection, who previously received the 2-dose regimen. [ABSTRACT FROM AUTHOR]
Published: 2022
Full Text: View/download PDF

21. Safety and immunogenicity of a two-dose heterologous Ad26.ZEBOV and MVA-BN-Filo Ebola vaccine regimen in adults in Europe (EBOVAC2): a randomised, observer-blind, participant-blind, placebo-controlled, phase 2 trial

Author: Pollard, Andrew J, primary, Launay, Odile, additional, Lelievre, Jean-Daniel, additional, Lacabaratz, Christine, additional, Grande, Sophie, additional, Goldstein, Neil, additional, Robinson, Cynthia, additional, Gaddah, Auguste, additional, Bockstal, Viki, additional, Wiedemann, Aurelie, additional, Leyssen, Maarten, additional, Luhn, Kerstin, additional, Richert, Laura, additional, Bétard, Christine, additional, Gibani, Malick M, additional, Clutterbuck, Elizabeth A, additional, Snape, Matthew D, additional, Levy, Yves, additional, Douoguih, Macaya, additional, Thiebaut, Rodolphe, additional, McShane, Christopher, additional, Callendret, Benoit, additional, Dincq, Stephanie, additional, Ferrault, Camille, additional, Chai, Siew Pin, additional, Gyselen, Maire Paule, additional, van Looveren, Marleen, additional, van Ballert, Sylvia, additional, de Cnodder, Tinne, additional, Roza, Len, additional, Forcheh, Chiara, additional, Stevens, Kate, additional, Mastrandrea, Carmela, additional, de Ridder, Sanne, additional, Gundluru, Rachana, additional, Swales, Nathalie, additional, Errijegers, Vanessa, additional, Willems, Wouter, additional, Roorda, Veronika, additional, Orzabal, Nicola, additional, Assenberg, Magdalena, additional, Vialatte, Karine, additional, Remblier, Frédéric, additional, Porcar, Elodie, additional, Ottavi, Anton, additional, Destandau, Eugénie, additional, Schwimmer, Christine, additional, Moinot, Laetitia, additional, Wallet, Cédrick, additional, Allais, Florence, additional, Savel, Hélène, additional, Nedjaai, Naouel, additional, Maugard, Anaïs, additional, Lenzi, Nehza, additional, Loulergue, Pierre, additional, Bahuaud, Mathilde, additional, Lainé, Fabrice, additional, Laviolle, Bruno, additional, Boissel, Nolwenn, additional, Thébault, Elise, additional, Vallée, David, additional, Nicolas, Jean-François, additional, Gilbert, Sophie, additional, Dahel, Karima, additional, Sagorny, Karen, additional, Lucht, Frédéric, additional, Paul, Stéphane, additional, Haccourt Chanavat, Alice, additional, Charra, Florent, additional, Mutter, Catherine, additional, Lambour, Monique, additional, Muller, Caroline, additional, Hutt-Clauss, Anne, additional, Aranda, Olivia, additional, Bernard, Louis, additional, Gissot, Valérie, additional, Hallouin-Bernard, Marie-Charlotte, additional, Goudeau, Alain, additional, Suzzoni, Steve, additional, Auostin, Eva, additional, Brick, Lysiane, additional, Lopez-Zaragoza, Jose-Luis, additional, Melic, Giovanna, additional, Carvalho, Murial, additional, Chesnel, Chrystel, additional, Hocini, Hakim, additional, Wiedemann, Aurélie, additional, Hanot, Laurent, additional, Rieux, Véronique, additional, Puri, Adeep, additional, Adeloye, Temitope, additional, Boyce, Malcolm, additional, Dennison, Jeremy, additional, Loewenstein, Inge, additional, Sahgal, Omar, additional, van den Berg, Frans, additional, Calvert, Wendy, additional, Faldon, Mary, additional, McClain, Bruce, additional, Newell, Marie-Lousie, additional, and Molenberghs, Geert, additional
Published: 2021
Full Text: View/download PDF

22. A model for establishment, maintenance and reactivation of the immune response after vaccination against Ebola virus

Author: Balelli, Irene, Pasin, Chloé, Prague, Mélanie, Crauste, Fabien, Effelterre, Thierry Van, Bockstal, Viki, Solforosi, Laura, Thiébaut, Rodolphe, Statistics In System biology and Translational Medicine (SISTM), Inria Bordeaux - Sud-Ouest, Institut National de Recherche en Informatique et en Automatique (Inria)-Institut National de Recherche en Informatique et en Automatique (Inria)-Epidémiologie et Biostatistique [Bordeaux], Université Bordeaux Segalen - Bordeaux 2-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Bordeaux Segalen - Bordeaux 2-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Institut National de la Santé et de la Recherche Médicale (INSERM), Vaccine Research Institute (VRI), Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), Bordeaux population health (BPH), Université de Bordeaux (UB)-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Institut National de la Santé et de la Recherche Médicale (INSERM), Columbia University Medical Center (CUMC), Columbia University [New York], Institut de Mathématiques de Bordeaux (IMB), Université Bordeaux Segalen - Bordeaux 2-Université Sciences et Technologies - Bordeaux 1-Université de Bordeaux (UB)-Institut Polytechnique de Bordeaux (Bordeaux INP)-Centre National de la Recherche Scientifique (CNRS), Janssen Pharmaceutica [Beerse], Janssen Vaccines & Prevention [Leiden], This work has received funding from the Innovative Medicines Initiative2 Joint Undertaking under Grant Agreement EBOVAC1 (No. 115854). This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA. This work was also supported by the Investissements d’Avenir program managed by the ANR under reference ANR-10-LABX-77., Institut National de Recherche en Informatique et en Automatique (Inria)-Institut National de Recherche en Informatique et en Automatique (Inria)- Bordeaux population health (BPH), Université de Bordeaux (UB)-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Bordeaux (UB)-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Institut National de la Santé et de la Recherche Médicale (INSERM), Epidémiologie et Biostatistique [Bordeaux], Université Bordeaux Segalen - Bordeaux 2-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Bordeaux Segalen - Bordeaux 2-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Inria Bordeaux - Sud-Ouest, Institut National de Recherche en Informatique et en Automatique (Inria)-Institut National de Recherche en Informatique et en Automatique (Inria), This work has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under Grant Agreement EBOVAC1 (N° 115854). This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA. The funder of the study had no role in the study design, data collection, data analysis, data interpretation, or writing the report. The corresponding author had full access to all the data in the study and had final responsibility for the decision to submit for publication. This work was also supported by the Investissements d’Avenir program managed by the ANR under reference ANR-10-LABX-77., Université Bordeaux Segalen - Bordeaux 2-Université Sciences et Technologies - Bordeaux 1 (UB)-Université de Bordeaux (UB)-Institut Polytechnique de Bordeaux (Bordeaux INP)-Centre National de la Recherche Scientifique (CNRS), and Balelli, Irene
Subjects: Mechanistic modeling, Vaccination, [MATH] Mathematics [math], Immunological memory, SISTM, [SDV.IMM.VAC] Life Sciences [q-bio]/Immunology/Vaccinology, Heterologous vaccination, Calibration, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, [SDV.IMM.VAC]Life Sciences [q-bio]/Immunology/Vaccinology, [MATH]Mathematics [math], Sensitivity analysis, Ebola Virus, Identifiability analysis
Abstract: International audience; The 2014-2016 Ebola outbreak in West Africa has triggered accelerated development of several preventive vaccines against Ebola virus. Under the EBOVAC1 consortium, three phase I studies were carried out to assess safety and immunogenicity of a two-dose heterologous vaccination regimen developed by Janssen Vaccines and Prevention in collaboration with Bavarian Nordic. To describe the immune responses induced by the two-dose heterologous vaccine regimen, we propose a mechanistic ODE based model, which takes into account the role of immunological memory. We perform identifiability and sensitivity analysis of the proposed model to establish which kind of biological data are ideally needed in order to accurately estimate parameters, and additionally, which of those are non-identifiable based on the available data. Antibody concentrations data from phase I studies have been used to calibrate the model and show its ability in reproducing the observed antibody dynamics. Together with other factors, the establishment of an effective and reactive immunological memory is of pivotal importance for several prophylactic vaccines. We show that introducing a memory compartment in our calibrated model allows to evaluate the magnitude of the immune response induced by a booster dose and its long-term persistence afterwards.
Published: 2020

23. A Critical Blimp-1-Dependent IL-10 Regulatory Pathway in T Cells Protects From a Lethal Pro-inflammatory Cytokine Storm During Acute Experimental Trypanosoma brucei Infection

Author: De Trez, Carl, Stijlemans, Benoît, Bockstal, Viki, Cnops, Jennifer, Korf, Hannelie, Van Snick, Jacques, Caljon, Guy, Muraille, Eric, Humphreys, Ian R., Boon, Louis, Van Ginderachter, Jo A, Magez, Stefan, De Trez, Carl, Stijlemans, Benoît, Bockstal, Viki, Cnops, Jennifer, Korf, Hannelie, Van Snick, Jacques, Caljon, Guy, Muraille, Eric, Humphreys, Ian R., Boon, Louis, Van Ginderachter, Jo A, and Magez, Stefan
Abstract: info:eu-repo/semantics/published
Published: 2020

24. Safety and Immunogenicity of an Accelerated Ebola Vaccination Schedule in People With and Without Human Immunodeficiency Virus: A Randomized Clinical Trial

Author: Ake, Julie A., primary, Paolino, Kristopher, additional, Hutter, Jack N., additional, Biggs Cicatelli, Susan, additional, Eller, Leigh Anne, additional, Eller, Michael A., additional, Costanzo, Margaret C., additional, Paquin-Proulx, Dominic, additional, Robb, Merlin L., additional, Tran, Chi L., additional, Anova, Lalaine, additional, Jagodzinski, Linda L., additional, Ward, Lucy A., additional, Kilgore, Nicole, additional, Rusnak, Janice, additional, Bounds, Callie, additional, Badorrek, Christopher S., additional, Hooper, Jay W., additional, Kwilas, Steve, additional, Ilsbroux, Ine, additional, Nkafu Anumendem, Dickson, additional, Gaddah, Auguste, additional, Shukarev, Georgi, additional, Bockstal, Viki, additional, Luhn, Kerstin, additional, Douoguih, Macaya, additional, and Robinson, Cynthia, additional
Published: 2021
Full Text: View/download PDF

25. Safety and Immunogenicity of Heterologous and Homologous 2-Dose Regimens of Adenovirus Serotype 26– and Modified Vaccinia Ankara–Vectored Ebola Vaccines: A Randomized, Controlled Phase 1 Study

Author: Goldstein, Neil, primary, Bockstal, Viki, additional, Bart, Stephan, additional, Luhn, Kerstin, additional, Robinson, Cynthia, additional, Gaddah, Auguste, additional, Callendret, Benoit, additional, and Douoguih, Macaya, additional
Published: 2020
Full Text: View/download PDF

26. A Critical Blimp-1-Dependent IL-10 Regulatory Pathway in T Cells Protects From a Lethal Pro-inflammatory Cytokine Storm During Acute Experimental Trypanosoma brucei Infection

Author: De Trez, Carl, primary, Stijlemans, Benoit, additional, Bockstal, Viki, additional, Cnops, Jennifer, additional, Korf, Hannelie, additional, Van Snick, Jacques, additional, Caljon, Guy, additional, Muraille, Eric, additional, Humphreys, Ian R., additional, Boon, Louis, additional, Van Ginderachter, Jo A., additional, and Magez, Stefan, additional
Published: 2020
Full Text: View/download PDF

27. Antibody-Dependent Natural Killer Cell Activation After Ebola Vaccination

Author: Wagstaffe, Helen R, primary, Clutterbuck, Elizabeth A, additional, Bockstal, Viki, additional, Stoop, Jeroen N, additional, Luhn, Kerstin, additional, Douoguih, Macaya, additional, Shukarev, Georgi, additional, Snape, Matthew D, additional, Pollard, Andrew J, additional, Riley, Eleanor M, additional, and Goodier, Martin R, additional
Published: 2019
Full Text: View/download PDF

28. Dynamics of the Humoral Immune Response to a Prime-Boost Ebola Vaccine: Quantification and Sources of Variation

Author: Pasin, Chloé, Balelli, Irene, van Effelterre, Thierry, Bockstal, Viki, Solforosi, Laura, Prague, Melanie, Douoguih, Macaya, Thiébaut, Rodolphe, Statistics In System biology and Translational Medicine (SISTM), Inria Bordeaux - Sud-Ouest, Institut National de Recherche en Informatique et en Automatique (Inria)-Institut National de Recherche en Informatique et en Automatique (Inria)- Bordeaux population health (BPH), Université de Bordeaux (UB)-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Bordeaux (UB)-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Institut National de la Santé et de la Recherche Médicale (INSERM), Janssen Pharmaceutica [Beerse], Janssen Vaccines & Prevention [Leiden], This work has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement EBOVAC1 (no. 115854). This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation program and EFPIA. This work was also supported by the Investissements d’Avenir program managed by the ANR under reference ANR-10-LABX-77., Bordeaux population health (BPH), Université de Bordeaux (UB)-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Institut National de la Santé et de la Recherche Médicale (INSERM), Institut National de Recherche en Informatique et en Automatique (Inria)-Institut National de Recherche en Informatique et en Automatique (Inria)-Epidémiologie et Biostatistique [Bordeaux], Université Bordeaux Segalen - Bordeaux 2-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Bordeaux Segalen - Bordeaux 2-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Institut National de la Santé et de la Recherche Médicale (INSERM), Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Université de Bordeaux (UB), and Admin, Oskar
Subjects: Male, Immunization, Secondary, Enzyme-Linked Immunosorbent Assay, Antibodies, Viral, Tanzania, [SDV.IMM.VAC] Life Sciences [q-bio]/Immunology/Vaccinology, vaccine, Vaccines and Antiviral Agents, Humans, Uganda, Ebola Vaccines, Immunity, Cellular, [STAT.AP]Statistics [stat]/Applications [stat.AP], Clinical Trials, Phase I as Topic, Vaccination, antibody response, Hemorrhagic Fever, Ebola, Models, Theoretical, Ebolavirus, Kenya, mechanistic modeling, United Kingdom, Immunity, Humoral, Antibody Formation, Ebola, Female, [SDV.IMM.VAC]Life Sciences [q-bio]/Immunology/Vaccinology
Abstract: With no available licensed vaccines or therapies, the West African Ebola virus disease epidemic of 2014 to 2016 caused 11,310 deaths. Following this outbreak, the development of vaccines has been accelerated. Combining different vector-based vaccines as heterologous regimens could induce a durable immune response, assessed through antibody concentrations. Based on data from phase 1 trials in East Africa and Europe, the dynamics of the humoral immune response from 7 days after the boost immunization onwards were modeled to estimate the durability of the response and understand its variability. Antibody production is maintained by a population of long-lived cells. Estimation suggests that half of these cells can persist for at least 5 years in humans. Differences in prime-boost vaccine regimens affect only the short-term immune response. Geographical differences in long-lived cell dynamics were inferred, with higher long-term antibody concentrations induced in European participants., The Ebola vaccine based on Ad26.ZEBOV/MVA-BN-Filo prime-boost regimens is being evaluated in multiple clinical trials. The long-term immune response to the vaccine is unknown, including factors associated with the response and variability around the response. We analyzed data from three phase 1 trials performed by the EBOVAC1 Consortium in four countries: the United Kingdom, Kenya, Tanzania, and Uganda. Participants were randomized into four groups based on the interval between prime and boost immunizations (28 or 56 days) and the sequence in which Ad26.ZEBOV and MVA-BN-Filo were administered. Consecutive enzyme-linked immunosorbent assay (ELISA) measurements of the IgG binding antibody concentrations against the Kikwit glycoprotein (GP) were available for 177 participants to assess the humoral immune response up to 1 year postprime. Using a mathematical model for the dynamics of the humoral response, from 7 days after the boost immunization up to 1 year after the prime immunization, we estimated the durability of the antibody response and the influence of different factors on the dynamics of the humoral response. Ordinary differential equations (ODEs) described the dynamics of antibody response and two populations of antibody-secreting cells (ASCs), short-lived (SL) and long-lived (LL). Parameters of the ODEs were estimated using a population approach. We estimated that half of the LL ASCs could persist for at least 5 years. The vaccine regimen significantly affected the SL ASCs and the antibody peak but not the long-term response. The LL ASC compartment dynamics differed significantly by geographic regions analyzed, with a higher long-term antibody persistence in European subjects. These differences could not be explained by the observed differences in cellular immune response. IMPORTANCE With no available licensed vaccines or therapies, the West African Ebola virus disease epidemic of 2014 to 2016 caused 11,310 deaths. Following this outbreak, the development of vaccines has been accelerated. Combining different vector-based vaccines as heterologous regimens could induce a durable immune response, assessed through antibody concentrations. Based on data from phase 1 trials in East Africa and Europe, the dynamics of the humoral immune response from 7 days after the boost immunization onwards were modeled to estimate the durability of the response and understand its variability. Antibody production is maintained by a population of long-lived cells. Estimation suggests that half of these cells can persist for at least 5 years in humans. Differences in prime-boost vaccine regimens affect only the short-term immune response. Geographical differences in long-lived cell dynamics were inferred, with higher long-term antibody concentrations induced in European participants.
Published: 2019

29. A comparative study between outbred and inbred rat strains for the use in in vivo IPV potency testing

Author: Bockstal, Viki, Sanders, Barbara, Achterberg, Rogier, Tiemessen, Machteld, Bogaert, Lies, Van der Meer, Marjolein, Schuitemaker, Hanneke, and Zahn, Roland
Published: 2018
Full Text: View/download PDF

30. An inactivated poliovirus vaccine using Sabin strains produced on the serum-free PER.C6® cell culture platform is immunogenic and safe in a non-human primate model

Author: Bockstal, Viki, Tiemessen, Machteld M., Achterberg, Rogier, van Wordragen, Carlo, Knaapen, Ad M., Serroyen, Jan, Marissen, Wilfred E., Schuitemaker, Hanneke, Zahn, Roland, and Academic Medical Center
Subjects: complex mixtures
Abstract: Background: The World Health Organization recommends the development of affordable next-generation inactivated poliovirus vaccines (IPV) using attenuated poliovirus Sabin strains. Previously, we introduced a novel PER.C6® cell culture platform, which allows for high yield production of an affordable trivalent Sabin IPV vaccine. Methods: Immunogenicity and safety of this novel PER.C6®-based Sabin-IPV (sIPV) was assessed in rats and non-human primates (NHPs). NHPs received one of four different dose dilutions vaccine according to current human schedule (three prime-immunizations and one boost immunization). For comparison, NHPs received commercially available reference Salk IPV or sIPV. Results: Dose-dependent immunogenicity and good tolerability was observed for the PER.C6®-based sIPV formulations in rats and NHPs. In NHPs, the lowest tested dose that induced anti-Sabin virus-neutralizing antibody titers that were non-inferior to commercial sIPV after three immunizations was 5-7.5-25 D-antigen units for type 1, 2 and 3 respectively. Discussion: PER.C6®-based sIPV induced comparable immunogenicity to commercial Salk IPV and sIPV vaccines in NHPs. Together with the absence of any preclinical safety signals, these data warrant further testing in clinical trials. sIPV produced on the PER.C6® cell platform could be one solution to the need for an affordable and immunogenic IPV to achieve and maintain global polio eradication.
Published: 2018

31. Safety and Immunogenicity of a 2-Dose Heterologous Vaccination Regimen With Ad26.ZEBOV and MVA-BN-Filo Ebola Vaccines: 12-Month Data From a Phase 1 Randomized Clinical Trial in Uganda and Tanzania

Author: Anywaine, Zacchaeus, primary, Whitworth, Hilary, additional, Kaleebu, Pontiano, additional, Praygod, George, additional, Shukarev, Georgi, additional, Manno, Daniela, additional, Kapiga, Saidi, additional, Grosskurth, Heiner, additional, Kalluvya, Samuel, additional, Bockstal, Viki, additional, Anumendem, Dickson, additional, Luhn, Kerstin, additional, Robinson, Cynthia, additional, Douoguih, Macaya, additional, and Watson-Jones, Deborah, additional
Published: 2019
Full Text: View/download PDF

32. Safety and Immunogenicity of a 2-Dose Heterologous Vaccine Regimen With Ad26.ZEBOV and MVA-BN-Filo Ebola Vaccines: 12-Month Data From a Phase 1 Randomized Clinical Trial in Nairobi, Kenya

Author: Mutua, Gaudensia, primary, Anzala, Omu, additional, Luhn, Kerstin, additional, Robinson, Cynthia, additional, Bockstal, Viki, additional, Anumendem, Dickson, additional, and Douoguih, Macaya, additional
Published: 2019
Full Text: View/download PDF

33. Antibody-Dependent Natural Killer Cell Activation After Ebola Vaccination.

Author: Wagstaffe, Helen R, Clutterbuck, Elizabeth A, Bockstal, Viki, Stoop, Jeroen N, Luhn, Kerstin, Douoguih, Macaya, Shukarev, Georgi, Snape, Matthew D, Pollard, Andrew J, Riley, Eleanor M, and Goodier, Martin R
Subjects: KILLER cells, ANTIBODY-dependent cell cytotoxicity, EBOLA virus disease, VACCINATION, EBOLA virus, CONTACT tracing, EBOLA virus disease prevention, PROTEINS, RESEARCH, VIRAL vaccines, IMMUNIZATION, RESEARCH methodology, EVALUATION research, COMPARATIVE studies, IMMUNITY, GLYCOPROTEINS, RESEARCH funding, VIRAL antibodies
Abstract: Background: Antibody Fc-mediated functions, such as antibody-dependent cellular cytotoxicity, contribute to vaccine-induced protection against viral infections. Fc-mediated function of anti-Ebola glycoprotein (GP) antibodies suggest that Fc-dependent activation of effector cells, including natural killer (NK) cells, could play a role in vaccination against Ebola virus disease.Methods: We analyzed the effect on primary human NK cell activation of anti-Ebola GP antibody in the serum of United Kingdom-based volunteers vaccinated with the novel 2-dose heterologous adenovirus type 26.ZEBOV, modified vaccinia Ankara-BN-Filo vaccine regimen.Results: We demonstrate primary human NK cell CD107a and interferon γ expression, combined with down-regulation of CD16, in response to recombinant Ebola virus GP and post-vaccine dose 1 and dose 2 serum samples. These responses varied significantly with vaccine regimen, and NK cell activation was found to correlate with anti-GP antibody concentration. We also reveal an impact of NK cell differentiation phenotype on antibody-dependent NK cell activation, with highly differentiated CD56dimCD57+ NK cells being the most responsive.Conclusions: These findings highlight the dual importance of vaccine-induced antibody concentration and NK cell differentiation status in promoting Fc-mediated activation of NK cells after vaccination, raising a potential role for antibody-mediated NK cell activation in vaccine-induced immune responses. [ABSTRACT FROM AUTHOR]
Published: 2021
Full Text: View/download PDF

34. Trypanosoma brucei Co-opts NK Cells to Kill Splenic B2 B Cells

Author: Frenkel, Deborah, primary, Zhang, Fengqiu, additional, Guirnalda, Patrick, additional, Haynes, Carole, additional, Bockstal, Viki, additional, Radwanska, Magdalena, additional, Magez, Stefan, additional, and Black, Samuel J., additional
Published: 2016
Full Text: View/download PDF

35. Cold-Adapted Viral Attenuation (CAVA): Highly Temperature Sensitive Polioviruses as Novel Vaccine Strains for a Next Generation Inactivated Poliovirus Vaccine

Author: Sanders, Barbara P., primary, de los Rios Oakes, Isabel, additional, van Hoek, Vladimir, additional, Bockstal, Viki, additional, Kamphuis, Tobias, additional, Uil, Taco G., additional, Song, Yutong, additional, Cooper, Gillian, additional, Crawt, Laura E., additional, Martín, Javier, additional, Zahn, Roland, additional, Lewis, John, additional, Wimmer, Eckard, additional, Custers, Jerome H. H. V., additional, Schuitemaker, Hanneke, additional, Cello, Jeronimo, additional, and Edo-Matas, Diana, additional
Published: 2016
Full Text: View/download PDF

36. Development of a pHrodo-Based Assay for the Assessment of In Vitro and In Vivo Erythrophagocytosis during Experimental Trypanosomosis

Author: Stijlemans, Benoit, primary, Cnops, Jennifer, additional, Naniima, Peter, additional, Vaast, Axel, additional, Bockstal, Viki, additional, De Baetselier, Patrick, additional, and Magez, Stefan, additional
Published: 2015
Full Text: View/download PDF

37. Induction and regulation of Trypanosoma brucei VSG-specific antibody response

Author: Black, Samuel, Guirnalda, Patrick, Frenkel, Deborah, Haynes, Carole, Bockstal, Viki, and Department of Bio-engineering Sciences
Subjects: T. brucei, antibody clearance, B cell activation, B cell deletion
Abstract: The review addresses how infection with Trypanosoma brucei affects the development, survival and functions of B lymphocytes in mice. It discusses (1) the contributions of antibodies to trypanosome clearance from the bloodstream, (2) how B lymphocytes, the precursors of antibody producing plasma cells, interact with membrane form variable surface glycoprotein (VSG), i.e. with monovalent antigen that is free to diffuse within the lipid bilayer of the trypanosome plasma membrane and consequently can cross-link B cell antigen specific receptors by indirect processes only and (3) the extent and underlying causes of dysregulation of humoral immune responses in infected mice, focusing on the impact of wild type and GPI-PLC?/? trypanosomes on bone marrow and extramedullary B lymphopoiesis, B cell maturation and survival.
Published: 2010

38. The central role of macrophages in trypanosomiasis-associated anemia: rationale for therapeutical approaches.

Author: Stijlemans, Benoît, Vankrunkelsven, Ann, Caljon, Guy, Bockstal, Viki, Guilliams, Martin, Bosschaerts, Tom, Beschin, Alain, Raes, Geert, Magez, Stefan, De Baetselier, Patrick, Stijlemans, Benoît, Vankrunkelsven, Ann, Caljon, Guy, Bockstal, Viki, Guilliams, Martin, Bosschaerts, Tom, Beschin, Alain, Raes, Geert, Magez, Stefan, and De Baetselier, Patrick
Abstract: Bovine African trypanosomiasis causes severe economical problems on the African continent and one of the most prominent immunopathological parameters associated with this parasitic infection is anemia. In this report we review the current knowledge of the mechanisms underlying trypanosomiasis-associated anemia. In first instance, the central role of macrophages and particularly their activation state in determining the outcome of the disease (i.e. trypanosusceptibility versus trypanotolerance) will be discussed. In essence, while persistence of classically activated macrophages (M1) contributes to anemia development, switching towards alternatively activated macrophages (M2) alleviates pathology including anemia. Secondly, while parasite-derived glycolipids such as the glycosylphosphatidylinositol (GPI) induce M1, host-derived IL-10 blocks M1-mediated inflammation, promotes M2 development and prevents anemia development. In this context, strategies aimed at inducing the M1 to M2 switch, such as GPI-based treatment, adenoviral delivery of IL-10 and induction of IL-10 producing regulatory T cells will be discussed. Finally, the crucial role of iron-homeostasis in trypanosomiasis-associated anemia development will be documented to stress the analogy with anemia of chronic disease (ACD), hereby providing new insight that might contribute to the treatment of ACD., Journal Article, Research Support, Non-U.S. Gov't, Review, info:eu-repo/semantics/published
Published: 2010

39. T. brucei Infection Reduces B Lymphopoiesis in Bone Marrow and Truncates Compensatory Splenic Lymphopoiesis through Transitional B-Cell Apoptosis

Author: Bockstal, Viki, primary, Guirnalda, Patrick, additional, Caljon, Guy, additional, Goenka, Radhika, additional, Telfer, Janice C., additional, Frenkel, Deborah, additional, Radwanska, Magdalena, additional, Magez, Stefan, additional, and Black, Samuel J., additional
Published: 2011
Full Text: View/download PDF

40. Acute Disruption of Bone Marrow B Lymphopoiesis and Apoptosis of Transitional and Marginal Zone B Cells in the Spleen following a Blood-StagePlasmodium chabaudiInfection in Mice

Author: Bockstal, Viki, primary, Geurts, Nathalie, additional, and Magez, Stefan, additional
Published: 2011
Full Text: View/download PDF

41. The Central Role of Macrophages in Trypanosomiasis-Associated Anemia:Rationale for Therapeutical Approaches

Author: Stijlemans, Benoit, primary, Vankrunkelsven, Ann, additional, Caljon, Guy, additional, Bockstal, Viki, additional, Guilliams, Martin, additional, Bosschaerts, Tom, additional, Beschin, Alain, additional, Raes, Geert, additional, Magez, Stefan, additional, and Baetselier, Patrick, additional
Published: 2010
Full Text: View/download PDF

42. Acute Disruption of Bone Marrow B Lymphopoiesis and Apoptosis of Transitional and Marginal Zone B Cells in the Spleen following a Blood-Stage Plasmodium chabaudi Infection in Mice.

Author: Bockstal, Viki, Geurts, Nathalie, and Magez, Stefan
Subjects: *PARASITOLOGY, *PLASMODIUM, *BONE marrow diseases, *APOPTOSIS, *SPLEEN, *LABORATORY mice, *CHEMOKINES
Abstract: B cells and antibodies are essential for the protective immune response against a blood-stage Plasmodium infection. Although extensive research has focused on memory as well as plasma B-cell responses during infection, little is known about how malaria affects B-cell development and splenic maturation into marginal zone B (MZB) and follicular B (FoB) cells. In this study, we show that acute Plasmodium chabaudi AS infection in C57Bl/6 mice causes severe disruption of B lymphopoiesis in the bone marrow, affecting in particular pro-, pre-, and immature B cells as well as the expression of the bone marrow B-cell retention chemokine CXCL12. In addition, elevated apoptosis of transitional T2 and marginal zone (MZ) B cells was observed during and subsequent to the control of the first wave of parasitemia. In contrast, Folllicular (Fo) B cells levels were retained in the spleen throughout the infection, suggesting that these are essential for parasite clearance and proper infection control. [ABSTRACT FROM AUTHOR]
Published: 2011
Full Text: View/download PDF

43. Partnership for Research on Ebola VACcination (PREVAC): protocol of a randomized, double-blind, placebo-controlled phase 2 clinical trial evaluating three vaccine strategies against Ebola in healthy volunteers in four West African countries

Author: Badio, Moses, Lhomme, Edouard, Kieh, Mark, Beavogui, Abdoul Habib, Kennedy, Stephen B., Doumbia, Seydou, Leigh, Bailah, Sow, Samba O., Diallo, Alpha, Fusco, Daniela, Kirchoff, Matthew, Termote, Monique, Vatrinet, Renaud, Wentworth, Deborah, Esperou, Helène, Lane, H. Clifford, Pierson, Jerome, Watson-Jones, Deborah, Roy, Céline, D’Ortenzio, Eric, Greenwood, Brian, Chêne, Genevieve, Richert, Laura, Neaton, James D., Yazdanpanah, Yazdan, Abdoulaye, Coulibaly, Aboulhab, Jamilia, Akoo, Pauline, Akpa, Esther, Akpata, Robert, Albert, Sara, Ale, Boni Maxime, C. Andrews, Benetta, Anoma, Stephane, Assiandi, Saw-San, Augier, Augustin, Awuondo, Ken, Bagayoko, Aminata, Bakare, Nyasha, Balde, Abby, Bangura, Lamin Molecule, Barrington, Kesha, Barte de Saint Fare, Eric, Baseler, Beth, Bauder, Ali, Bauduin, Claire, Bawo, Luke, Habib Beavogui, Abdoul, Belson, Michael, Bererd, Marion, Beyslow, Teedoh, Binachon, Blandine, Blie, Julie, Bockstal, Viki, Boire, Youba, Boison, Patricia, Bolay, Fatorma, Boly, Aliou, Gael Borg, Anne, Bowers, Donna, Browne, Sarah, Cagniard, Barbara, Cahill, Kelly, Abdoulaye Camara, Aissata, Camara, Keira, Camara, Modet, Campion, Cécilia, Cash, Jennifer, Pin Chai, Siew, Chambelin, Francois, Chieck, Keita, Chêne, Geneviève, Ciancia, Séverine, Ndiaga Cisse, Papa, Clide, Elfrida, Colin, Céline, Coller, Beth-Ann, Siaka Conde, Djélikan, Cone, Katherine, Connor, Laurie, Connor, Nicholas, Boye Cooper, Joseph, Couffin-Cardiergues, Sandrine, Coulibaly, Fatoumata, Coulibaly, Mariam, Dabakuyo-Yonli, Sandrine, Dabitao, Djeneba, Damerval, Thierry, Davis, Bionca, Fadlu Deen, Gibrilla, Dekeyster, Eline, Delfraissy, Jean-François, Delmas, Christelle, Dembele, Rokia, Diakite, Mahamadou, Saliou Diallo, Mamadou, Diarra, Ayouba, Diawara, Oualy, Dighero-kemp, Bonnie, Diop, Samba, Diouf, Waly, Doepel, Laurie, Moise Doumbia, Moussa, Douoguih, Macaya, DuChêne, Alain, Duvenhage, Michael, Eckes, Risa Eckes, Egan, Avril, Enria, Luisa, Espérou, Hélène, Etienne, Cécile, Eyler, Allison, Faye, Sylvain, Fernandez, José, Fleck, Suzanne, Fofana, Vemy, Franklin, Kokulo, Gaddah, Auguste, Gaignet, Marylène, Gallagher, Katherine, Garcia Gozalbes, Julia, Grandits, Greg, Gray, Maima, Greijer, Astrid, Grue, Louis, Grund, Birgit, Guindo, Oumar, Gupta, Swati, Haidara, Fadima, Hamze, Benjamin, Hancox, Emma, Hart, Gavin, Hébert, Jean-Christophe, Heijnen, Esther, Hensley, Patricia, Hensley, Lisa, Higgs, Elisabeth, Hilton, Trudi, Holley, Preston, Hoover, Marie, Howard, Natasha, Hughes, Melissa, Ilo, Dicko, Imes, Jen, Irvine, Skip, Ishola, David, Jacob, Will, Jato, Yvonne, Johnson, Melvin, Jusu, Morrison, Sidiki Kaba, Aboubacar, Kante, Myriam, Katoudi, Judith, Keita, Sakoba, Kennedy, Stephen, Jide Keshinro, Babajide, Khon, Brian, Kiawu, Hassan, Kirchoff, Matt, Kodio, Mamoudou, Koivogui, Lamine, Kombi, Tania, Kopka, Stacy, Kowuors, Dickens, Lacabaratz, Christine, Lacarra, Boris, Lambert, Laurie, Lane, Cliff, Lee, Shona, Lees, Shelley, Lefevre, Annabelle, Lemarcis, Frederic, Lévy, Yves, Levy-Marchal, Claire, Lewally, Jemilla, Leyssen, Maarten, Liu, Ken, Lowe, Brett, Lysander, Julia, Madelaine, Claire, Mahamadou, Ibrah, Manno, Daniela, Marchand, Johnathan, Marynissen, Siegfried, Massaquoi, Moses B.F., Masson, Laure, Matard, Charly, Matthew, Onorato, McCullough, John, Mercier, Noemie, Michavila, Pauline, Miller, Tracey, Miranda, Alejandra, Mohamed, Soumaya, Mooney, Tom, Morsch, Hans, Muamba, Dally, Lukoo Ndamenyaa, Rita, Neaton, James, Neboua, Désiré, Nelson, Micki, Newell, Kevin, Nguyen, Vinh-kim, Nielsen, Leslie, Niouma, Millimouno, Offergeld, Kim, Onorato, Matthew, Onwuchekwa, Uma, Orsega, Susan, Ortega-Perez, Inmaculada, Osborne, Cynthia, Otieno, Tuda, Patel, Sushma, Peiffer-Smadj, Nathan, Phillips, Robert, Piot, Peter, Piziali, Micheal, Pong, Stephany, Proffitt, Calvin, Quach, Alexandre, Ramers-verhoeven, Corina, Randunu, Nadeeka, Rivière, Priscille, Robinson, Cynthia, Van Roey, Griet, Falk Russell, Amy, Samai, Sibiry Samake, Mohamed, Sangare, Ballan, Sanogo, Ibrahim, Sadio Sarro, Yeya, Sarro, Sadio, Saville, Mélanie, Sawadogo, Serge, Schvartz, Maxime, Schwimmer, Christine, Secka, Fatou, Seraphin, Jacques, Shelley, Denise, Siddiqui, Sophia, Simon, Jakub, Simpson, Shelly, Muyisa Sivahera, Billy, Skip, Irvine, Slater, Karen, Smolskis, Mary, Smout, Elizabeth, Snowden, Emily, Soutthiphong, Anne-Aygline, Sow, Samba, Sow, Ydrissa, Splinter, Daniel, Spreng, Simone, Stapleton, Helen, Stoop, Jeroen, Sweeney, Mary, Tamba, Sienneh, Tapia, Mili, Tegli, Jemee, Thiebaut, Rodolphe, Thompson, Greg, Tierney, John, Touré, Abdoulaye, Traina, Stacey, Traore, Awa, Traore, Moussa, Tyee, Tijili, Vallée, David, Van Der Donck, Katrien V, Verbruggen, Nadia, Vincent, Corine, Vogel, Susan, Wallet, Cedrick, Wesseh, Cecelia, Whitworth, Jimmy, Wiedemann, Aurelie, Willems, Wouter, Williams, Julian, Wilson, Barthalomew, Wissedi, Njoh, Wolf, Jayanthi, Woods, Ian, Wurie, Alie, Yamadjako, Delphine, Yaradouno, Marcel, Zeggani, Zara, Statistics In System biology and Translational Medicine (SISTM), Inria Bordeaux - Sud-Ouest, Institut National de Recherche en Informatique et en Automatique (Inria)-Institut National de Recherche en Informatique et en Automatique (Inria)- Bordeaux population health (BPH), Université de Bordeaux (UB)-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Bordeaux (UB)-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Institut National de la Santé et de la Recherche Médicale (INSERM), PREVAIL, Centre National de Formation et de Recherche en Santé Rurale [Maférinyah, Guinée] (CNFRSR), Malaria Research and Training Center [Bamako, Mali], Université de Bamako, University of Sierra Leone (USL), Institut National de Santé Publique [Bamako] = National Institute of Research on Public Health (INSP), ANRS - Maladies infectieuses émergentes (ANRS - MIE), Institut National de la Santé et de la Recherche Médicale (INSERM), Bordeaux population health (BPH), Université de Bordeaux (UB)-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Institut National de la Santé et de la Recherche Médicale (INSERM), University of Minnesota [Twin Cities] (UMN), University of Minnesota System, Pôle de Recherche Clinique [Paris] (PRC), National Institute of Allergy and Infectious Diseases [Bethesda] (NIAID-NIH), National Institutes of Health [Bethesda] (NIH), and London School of Hygiene and Tropical Medicine (LSHTM)
Subjects: [SDV]Life Sciences [q-bio]
Abstract: International audience; Abstract Introduction The Ebola virus disease (EVD) outbreak in 2014–2016 in West Africa was the largest on record and provided an opportunity for large clinical trials and accelerated efforts to develop an effective and safe preventative vaccine. Multiple questions regarding the safety, immunogenicity, and efficacy of EVD vaccines remain unanswered. To address these gaps in the evidence base, the Partnership for Research on Ebola Vaccines (PREVAC) trial was designed. This paper describes the design, methods, and baseline results of the PREVAC trial and discusses challenges that led to different protocol amendments. Methods This is a randomized, double-blind, placebo-controlled phase 2 clinical trial of three vaccine strategies against the Ebola virus in healthy volunteers 1 year of age and above. The three vaccine strategies being studied are the rVSVΔG-ZEBOV-GP vaccine, with and without a booster dose at 56 days, and the Ad26.ZEBOV,MVA-FN-Filo vaccine regimen with Ad26.ZEBOV given as the first dose and the MVA-FN-Filo vaccination given 56 days later. There have been 4 versions of the protocol with those enrolled in Version 4.0 comprising the primary analysis cohort. The primary endpoint is based on the antibody titer against the Ebola virus surface glycoprotein measured 12 months following the final injection. Results From April 2017 to December 2018, a total of 5002 volunteers were screened and 4789 enrolled. Participants were enrolled at 6 sites in four countries (Guinea, Liberia, Sierra Leone, and Mali). Of the 4789 participants, 2560 (53%) were adults and 2229 (47%) were children. Those
Full Text: View/download PDF

44. Innate and cellular immune response to the Ebola vaccine Ad26.ZEBOV, MVA-BN-Filo: an ancillary study of the EBL2001 phase II trial.

Author: Lacabaratz C, Durand M, Wiedemann A, Foucat E, Surénaud M, Krief C, Guillaumat L, Robinson C, Luhn K, Bockstal V, Thiébaut R, Richert L, and Lévy Y
Abstract: Background: The EBL2001 phase 2 trial tested the two-dose Ad26.ZEBOV, MVA-BN-Filo Ebola vaccine in Europe. Safety and humoral immunogenicity assessments led to EU market authorization in 2020. Complementary analyses of immune responses are warranted to better characterize vaccine effects., Methods: We conducted an ancillary study to analyze changes in the serum and cellular responses. Serum biomarkers of activation/inflammation were evaluated using a Luminex assay. Vaccine-elicited T cell responses and functions were evaluated assessing their phenotype, cytokine production, proliferation and cytotoxic potential. Integrated data analysis was performed through correlation and principal component analysis of serum biomarkers and cellular immune responses., Results: Forty-eight volunteers were included. The Ad26.ZEBOV, MVA-BN-Filo vaccine elicited: i) serum increase of inflammatory/activation markers mainly at 1 day after the Ad26.ZEBOV vaccine; ii) durable EBOV-specific T cell proliferation and CD8+ T cells exhibiting a cytotoxic phenotype after Ad26.ZEBOV prime, after MVA-BN-Filo boost and 6 months post vaccination. Integrated analysis revealed correlations between: i) EBOV-specific CD8+ T cell proliferation and cytotoxic phenotype; ii) high EBOV-specific CD8+ T cell cytotoxic phenotype and low inflammatory marker IL-8 at day 1 post vaccination., Discussion: This study provides unique insights into the in vivo contribution of proliferation/cytotoxic CD8+ T cells and inflammation to the Ad26.ZEBOV, MVA-BN-Filo vaccine-induced potency., (© The Author(s) 2024. Published by Oxford University Press on behalf of Infectious Diseases Society of America. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.)
Published: 2024
Full Text: View/download PDF

45. Safety and Immunogenicity of an Accelerated Ebola Vaccination Schedule in People with and without Human Immunodeficiency Virus: A Randomized Clinical Trial.

Author: Ake JA, Paolino K, Hutter JN, Cicatelli SB, Eller LA, Eller MA, Costanzo MC, Paquin-Proulx D, Robb ML, Tran CL, Anova L, Jagodzinski LL, Ward LA, Kilgore N, Rusnak J, Bounds C, Badorrek CS, Hooper JW, Kwilas SA, Ilsbroux I, Anumendem DN, Gaddah A, Shukarev G, Bockstal V, Luhn K, Douoguih M, and Robinson C
Abstract: The safety and immunogenicity of the two-dose Ebola vaccine regimen MVA-BN-Filo, Ad26.ZEBOV, 14 days apart, was evaluated in people without HIV (PWOH) and living with HIV (PLWH). In this observer-blind, placebo-controlled, phase 2 trial, healthy adults were randomized (4:1) to receive MVA-BN-Filo (dose 1) and Ad26.ZEBOV (dose 2), or two doses of saline/placebo, administered intramuscularly 14 days apart. The primary endpoints were safety (adverse events (AEs)) and immunogenicity (Ebola virus (EBOV) glycoprotein-specific binding antibody responses). Among 75 participants (n = 50 PWOH; n = 25 PLWH), 37% were female, the mean age was 44 years, and 56% were Black/African American. AEs were generally mild/moderate, with no vaccine-related serious AEs. At 21 days post-dose 2, EBOV glycoprotein-specific binding antibody responder rates were 100% among PWOH and 95% among PLWH; geometric mean antibody concentrations were 6286 EU/mL (n = 36) and 2005 EU/mL (n = 19), respectively. A total of 45 neutralizing and other functional antibody responses were frequently observed. Ebola-specific CD4+ and CD8+ T-cell responses were polyfunctional and durable to at least 12 months post-dose 2. The regimen was well tolerated and generated robust, durable immune responses in PWOH and PLWH. Findings support continued evaluation of accelerated vaccine schedules for rapid deployment in populations at immediate risk. Trial registration: NCT02598388 (submitted 14 November 2015).
Published: 2024
Full Text: View/download PDF

46. A model for establishment, maintenance and reactivation of the immune response after vaccination against Ebola virus.

Author: Balelli I, Pasin C, Prague M, Crauste F, Effelterre TV, Bockstal V, Solforosi L, and Thiébaut R
Subjects: Africa, Western, Hemorrhagic Fever, Ebola immunology, Hemorrhagic Fever, Ebola prevention & control, Humans, Vaccination, Ebola Vaccines immunology, Ebolavirus immunology, Immunity immunology, Models, Biological
Abstract: The 2014-2016 Ebola outbreak in West Africa has triggered accelerated development of several preventive vaccines against Ebola virus. Under the EBOVAC1 consortium, three phase I studies were carried out to assess safety and immunogenicity of a two-dose heterologous vaccination regimen developed by Janssen Vaccines and Prevention in collaboration with Bavarian Nordic. To describe the immune response induced by the two-dose heterologous vaccine regimen, we propose a mechanistic ODE based model, which takes into account the role of immunological memory. We perform identifiability and sensitivity analysis of the proposed model to establish which kind of biological data are ideally needed in order to accurately estimate parameters, and additionally, which of those are non-identifiable based on the available data. Antibody concentrations data from phase I studies have been used to calibrate the model and show its ability in reproducing the observed antibody dynamics. Together with other factors, the establishment of an effective and reactive immunological memory is of pivotal importance for several prophylactic vaccines. We show that introducing a memory compartment in our calibrated model allows to evaluate the magnitude of the immune response induced by a booster dose and its long-term persistence afterwards., (Copyright © 2020 The Author(s). Published by Elsevier Ltd.. All rights reserved.)
Published: 2020
Full Text: View/download PDF

47. Dynamics of the Humoral Immune Response to a Prime-Boost Ebola Vaccine: Quantification and Sources of Variation.

Author: Pasin C, Balelli I, Van Effelterre T, Bockstal V, Solforosi L, Prague M, Douoguih M, and Thiébaut R
Subjects: Antibodies, Viral immunology, Antibody Formation immunology, Clinical Trials, Phase I as Topic methods, Ebola Vaccines pharmacology, Ebolavirus immunology, Enzyme-Linked Immunosorbent Assay, Female, Hemorrhagic Fever, Ebola metabolism, Hemorrhagic Fever, Ebola virology, Humans, Immunity, Cellular drug effects, Immunization, Secondary methods, Kenya, Male, Models, Theoretical, Tanzania, Uganda, United Kingdom, Vaccination, Ebola Vaccines immunology, Immunity, Humoral drug effects
Abstract: The Ebola vaccine based on Ad26.ZEBOV/MVA-BN-Filo prime-boost regimens is being evaluated in multiple clinical trials. The long-term immune response to the vaccine is unknown, including factors associated with the response and variability around the response. We analyzed data from three phase 1 trials performed by the EBOVAC1 Consortium in four countries: the United Kingdom, Kenya, Tanzania, and Uganda. Participants were randomized into four groups based on the interval between prime and boost immunizations (28 or 56 days) and the sequence in which Ad26.ZEBOV and MVA-BN-Filo were administered. Consecutive enzyme-linked immunosorbent assay (ELISA) measurements of the IgG binding antibody concentrations against the Kikwit glycoprotein (GP) were available for 177 participants to assess the humoral immune response up to 1 year postprime. Using a mathematical model for the dynamics of the humoral response, from 7 days after the boost immunization up to 1 year after the prime immunization, we estimated the durability of the antibody response and the influence of different factors on the dynamics of the humoral response. Ordinary differential equations (ODEs) described the dynamics of antibody response and two populations of antibody-secreting cells (ASCs), short-lived (SL) and long-lived (LL). Parameters of the ODEs were estimated using a population approach. We estimated that half of the LL ASCs could persist for at least 5 years. The vaccine regimen significantly affected the SL ASCs and the antibody peak but not the long-term response. The LL ASC compartment dynamics differed significantly by geographic regions analyzed, with a higher long-term antibody persistence in European subjects. These differences could not be explained by the observed differences in cellular immune response. IMPORTANCE With no available licensed vaccines or therapies, the West African Ebola virus disease epidemic of 2014 to 2016 caused 11,310 deaths. Following this outbreak, the development of vaccines has been accelerated. Combining different vector-based vaccines as heterologous regimens could induce a durable immune response, assessed through antibody concentrations. Based on data from phase 1 trials in East Africa and Europe, the dynamics of the humoral immune response from 7 days after the boost immunization onwards were modeled to estimate the durability of the response and understand its variability. Antibody production is maintained by a population of long-lived cells. Estimation suggests that half of these cells can persist for at least 5 years in humans. Differences in prime-boost vaccine regimens affect only the short-term immune response. Geographical differences in long-lived cell dynamics were inferred, with higher long-term antibody concentrations induced in European participants., (Copyright © 2019 Pasin et al.)
Published: 2019
Full Text: View/download PDF

48. An inactivated poliovirus vaccine using Sabin strains produced on the serum-free PER.C6® cell culture platform is immunogenic and safe in a non-human primate model.

Author: Bockstal V, Tiemessen MM, Achterberg R, Van Wordragen C, Knaapen AM, Serroyen J, Marissen WE, Schuitemaker H, and Zahn R
Subjects: Animals, Antibodies, Neutralizing blood, Antibodies, Viral blood, Cell Culture Techniques, Culture Media, Serum-Free, Female, Immunization Schedule, Macaca fascicularis, Poliovirus growth & development, Poliovirus Vaccine, Inactivated administration & dosage, Poliovirus immunology, Poliovirus Vaccine, Inactivated adverse effects, Poliovirus Vaccine, Inactivated immunology
Abstract: Background: The World Health Organization recommends the development of affordable next-generation inactivated poliovirus vaccines (IPV) using attenuated poliovirus Sabin strains. Previously, we introduced a novel PER.C6® cell culture platform, which allows for high yield production of an affordable trivalent Sabin IPV vaccine., Methods: Immunogenicity and safety of this novel PER.C6®-based Sabin-IPV (sIPV) was assessed in rats and non-human primates (NHPs). NHPs received one of four different dose dilutions vaccine according to current human schedule (three prime-immunizations and one boost immunization). For comparison, NHPs received commercially available reference Salk IPV or sIPV., Results: Dose-dependent immunogenicity and good tolerability was observed for the PER.C6®-based sIPV formulations in rats and NHPs. In NHPs, the lowest tested dose that induced anti-Sabin virus-neutralizing antibody titers that were non-inferior to commercial sIPV after three immunizations was 5-7.5-25 D-antigen units for type 1, 2 and 3 respectively., Discussion: PER.C6®-based sIPV induced comparable immunogenicity to commercial Salk IPV and sIPV vaccines in NHPs. Together with the absence of any preclinical safety signals, these data warrant further testing in clinical trials. sIPV produced on the PER.C6® cell platform could be one solution to the need for an affordable and immunogenic IPV to achieve and maintain global polio eradication., (Copyright © 2018 The Author(s). Published by Elsevier Ltd.. All rights reserved.)
Published: 2018
Full Text: View/download PDF

49. The central role of macrophages in trypanosomiasis-associated anemia: rationale for therapeutical approaches.

Author: Stijlemans B, Vankrunkelsven A, Caljon G, Bockstal V, Guilliams M, Bosschaerts T, Beschin A, Raes G, Magez S, and De Baetselier P
Subjects: Anemia etiology, Animals, Glycosylphosphatidylinositols therapeutic use, Homeostasis, Humans, Interleukin-10 therapeutic use, Iron metabolism, Macrophage Activation, T-Lymphocytes, Regulatory physiology, Trypanosoma immunology, Trypanosoma physiology, Trypanosomiasis, African complications, Trypanosomiasis, African metabolism, Trypanosomiasis, African parasitology, Anemia therapy, Macrophages physiology, Trypanosomiasis, African immunology, Trypanosomiasis, African therapy
Abstract: Bovine African trypanosomiasis causes severe economical problems on the African continent and one of the most prominent immunopathological parameters associated with this parasitic infection is anemia. In this report we review the current knowledge of the mechanisms underlying trypanosomiasis-associated anemia. In first instance, the central role of macrophages and particularly their activation state in determining the outcome of the disease (i.e. trypanosusceptibility versus trypanotolerance) will be discussed. In essence, while persistence of classically activated macrophages (M1) contributes to anemia development, switching towards alternatively activated macrophages (M2) alleviates pathology including anemia. Secondly, while parasite-derived glycolipids such as the glycosylphosphatidylinositol (GPI) induce M1, host-derived IL-10 blocks M1-mediated inflammation, promotes M2 development and prevents anemia development. In this context, strategies aimed at inducing the M1 to M2 switch, such as GPI-based treatment, adenoviral delivery of IL-10 and induction of IL-10 producing regulatory T cells will be discussed. Finally, the crucial role of iron-homeostasis in trypanosomiasis-associated anemia development will be documented to stress the analogy with anemia of chronic disease (ACD), hereby providing new insight that might contribute to the treatment of ACD.
Published: 2010
Full Text: View/download PDF

Catalog

Books, media, physical & digital resources

See catalog results

Searchworks

Select search scope, currently: Articles Catalog books, media & more in Jio Institute collections Articles journal articles & other e-resources

Search

Search Constraints

Refine your results

Search Limiters

Topic

Publication Year Range

Language

Publication Type

Journal

Region

Database

Publisher

49 results on '"Bockstal, Viki"'

Search Results

Catalog

Select search scope, currently: Articles

Catalog

books, media & more in Jio Institute collections

Articles

journal articles & other e-resources