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1. MR1-Independent Activation of Human Mucosal-Associated Invariant T Cells by Mycobacteria

Author

Suliman, Sara, Murphy, Melissa, Musvosvi, Munyaradzi, Gela, Anele, Meermeier, Erin W, Geldenhuys, Hennie, Hopley, Christiaan, Toefy, Asma, Bilek, Nicole, Veldsman, Ashley, Hanekom, Willem A, Johnson, John L, Boom, W Henry, Obermoser, Gerlinde, Huang, Huang, Hatherill, Mark, Lewinsohn, David M, Nemes, Elisa, and Scriba, Thomas J

Subjects
Biomedical and Clinical Sciences, Immunology, Rare Diseases, Vaccine Related, Immunization, HIV/AIDS, Prevention, Infectious Diseases, Clinical Research, Tuberculosis, Tuberculosis Vaccine, Aetiology, 2.1 Biological and endogenous factors, Infection, Good Health and Well Being, Adolescent, Child, Cohort Studies, Cytokines, Histocompatibility Antigens Class I, Humans, Minor Histocompatibility Antigens, Mucosal-Associated Invariant T Cells, Mycobacterium tuberculosis, Receptors, Antigen, T-Cell, Biochemistry and cell biology
Abstract

Tuberculosis (TB) is the leading cause of mortality from a single infectious agent, Mycobacterium tuberculosis Relevant immune targets of the partially efficacious TB vaccine bacille Calmette-Guérin (BCG) remain poorly defined. Mucosal-associated invariant T (MAIT) cells are MHC-related protein 1 (MR1)-restricted T cells, which are reactive against M. tuberculosis, and underexplored as potential TB vaccine targets. We sought to determine whether BCG vaccination activated mycobacteria-specific MAIT cell responses in humans. We analyzed whole blood samples from M. tuberculosis-infected South African adults who were revaccinated with BCG after a six-month course of isoniazid preventative therapy. In vitro BCG stimulation potently induced IFN-γ expression by phenotypic (CD8+CD26+CD161+) MAIT cells, which constituted the majority (75%) of BCG-reactive IFN-γ-producing CD8+ T cells. BCG revaccination transiently expanded peripheral blood frequencies of BCG-reactive IFN-γ+ MAIT cells, which returned to baseline frequencies a year following vaccination. In another cohort of healthy adults who received BCG at birth, 53% of mycobacteria-reactive-activated CD8 T cells expressed CDR3α TCRs, previously reported as MAIT TCRs, expressing the canonical TRAV1-2-TRAJ33 MAIT TCRα rearrangement. CD26 and CD161 coexpression correlated with TRAV1-2+CD161+ phenotype more accurately in CD8+ than CD4-CD8- MAIT cells. Interestingly, BCG-induced IFN-γ expression by MAIT cells in vitro was mediated by the innate cytokines IL-12 and IL-18 more than MR1-induced TCR signaling, suggesting TCR-independent activation. Collectively, the data suggest that activation of blood MAIT cells by innate inflammatory cytokines is a major mechanism of responsiveness to vaccination with whole cell vaccines against TB or in vitro stimulation with mycobacteria (Clinical trial registration: NCT01119521).

Published
2019

2. Four-Gene Pan-African Blood Signature Predicts Progression to Tuberculosis

Author

Suliman, Sara, Thompson, Ethan G, Sutherland, Jayne, Weiner, January, Ota, Martin OC, Shankar, Smitha, Penn-Nicholson, Adam, Thiel, Bonnie, Erasmus, Mzwandile, Maertzdorf, Jeroen, Duffy, Fergal J, Hill, Philip C, Hughes, E Jane, Stanley, Kim, Downing, Katrina, Fisher, Michelle L, Valvo, Joe, Parida, Shreemanta K, van der Spuy, Gian, Tromp, Gerard, Adetifa, Ifedayo MO, Donkor, Simon, Howe, Rawleigh, Mayanja-Kizza, Harriet, Boom, W Henry, Dockrell, Hazel M, Ottenhoff, Tom HM, Hatherill, Mark, Aderem, Alan, Hanekom, Willem A, Scriba, Thomas J, Kaufmann, Stefan HE, Zak, Daniel E, Walzl, Gerhard, Black, Gillian F, Kriel, Magdalena, Du Plessis, Nelita, Nene, Nonhlanhla, Roberts, Teri, Kleynhans, Leanie, Gutschmidt, Andrea, Smith, Bronwyn, Loxton, Andre G, Chegou, Novel N, Tromp, Gerhardus, Tabb, David, Klein, Michel R, Haks, Marielle C, Franken, Kees LMC, Geluk, Annemieke, van Meijgaarden, Krista E, Joosten, Simone A, Joloba, Moses, Zalwango, Sarah, Nsereko, Mary, Okwera, Brenda, Kisingo, Hussein, Golinski, Robert, Jacobson, Marc, Dockrell, Hazel, Smith, Steven, Gorak-Stolinska, Patricia, Hur, Yun-Gyoung, Lalor, Maeve, Lee, Ji-Sook, Crampin, Amelia C, French, Neil, Ngwira, Bagrey, Ben-Smith, Anne, Watkins, Kate, Ambrose, Lyn, Simukonda, Felanji, Mvula, Hazzie, Chilongo, Femia, Saul, Jacky, Branson, Keith, Mahomed, Hassan, Bilek, Nicole, Xasa, Onke, Veldsman, Ashley, Fisher, Michelle, and Mulenga, Humphrey

Subjects
HIV/AIDS, Rare Diseases, Infectious Diseases, Tuberculosis, Clinical Research, Emerging Infectious Diseases, Prevention, Genetics, 2.1 Biological and endogenous factors, 4.2 Evaluation of markers and technologies, 4.1 Discovery and preclinical testing of markers and technologies, Aetiology, Detection, screening and diagnosis, Infection, Good Health and Well Being, GC6-74 cohort study team, The ACS cohort study team, biomarkers, gene expression, tuberculosis, Medical and Health Sciences, Respiratory System
Abstract

Rationale: Contacts of patients with tuberculosis (TB) constitute an important target population for preventive measures because they are at high risk of infection with Mycobacterium tuberculosis and progression to disease.Objectives: We investigated biosignatures with predictive ability for incident TB.Methods: In a case-control study nested within the Grand Challenges 6-74 longitudinal HIV-negative African cohort of exposed household contacts, we employed RNA sequencing, PCR, and the pair ratio algorithm in a training/test set approach. Overall, 79 progressors who developed TB between 3 and 24 months after diagnosis of index case and 328 matched nonprogressors who remained healthy during 24 months of follow-up were investigated.Measurements and Main Results: A four-transcript signature derived from samples in a South African and Gambian training set predicted progression up to two years before onset of disease in blinded test set samples from South Africa, the Gambia, and Ethiopia with little population-associated variability, and it was also validated in an external cohort of South African adolescents with latent M. tuberculosis infection. By contrast, published diagnostic or prognostic TB signatures were predicted in samples from some but not all three countries, indicating site-specific variability. Post hoc meta-analysis identified a single gene pair, C1QC/TRAV27 (complement C1q C-chain / T-cell receptor-α variable gene 27) that would consistently predict TB progression in household contacts from multiple African sites but not in infected adolescents without known recent exposure events.Conclusions: Collectively, we developed a simple whole blood-based PCR test to predict TB in recently exposed household contacts from diverse African populations. This test has potential for implementation in national TB contact investigation programs.

Published
2018

3. Validation of a host blood transcriptomic biomarker for pulmonary tuberculosis in people living with HIV: a prospective diagnostic and prognostic accuracy study

Author

Abrahams, Charmaine, Africa, Hadn, Ahlers, Petri, Arendsen, Denis, Badimo, Tebogo, Baepanye, Kagiso, Baepanye, Kesenogile Edna, Bande, Bianca, Batyi, Nomfuneko Cynthia, Beukes, Roslyn, Bontsi, Laudicia Tshenolo, Booi, Obakeng Peter, Botha, Mari Cathrin, Braaf, Samentra, Buhlungu, Sivuyile, Carstens, Alida, Chauke, Kgomotso Violet, Chinappa, Thilagavathy, Chung, Eva, Chung, Michelle, Clarke, Ken, Cloete, Yolundi, Coetzee, Lorraine, Collignon, Marelize, Companie, Alessandro, Corris, Cara-mia, Cwaile, Mooketsi Theophillius, Cwele, Thobelani, Davids, Ilse, Davies, Isabella Johanna, De Klerk, Emilia, de Kock, Marwou, Dhlamini, Audrey Lebohang, Diamond, Bongani, Didloff, Maria, Dlamini, Celaphiwe, Dolo, Palesa, Eyre, Candice, Feni, Tebogo, Ferreira, Juanita, Ferus, Christal, Fisher, Michelle, Flinn, Marika, Fransman, Bernadine, Galane, Welseh Phindile, Geldenhuys, Hennie, Gempies, Diann, Goliath, Thelma, Govender, Dhineshree, Gregg, Yolande, Gumede, Goodness, Gwamada, Zanele, Halti, Senzo, Hassiem, Rieyaat, Herling, Roxane, Herselman, Yulandi, Hughes, Ellis, Issel, Henry, Iyemosolo, Blanchard Mbay, Jali, Zandile, Janse Van Rensburg, Bonita, Jansen, Ruwiyda, Jeleni, James Michael, Jonkane, Olebogeng, Julies, Fabio, Kafaar, Fazlin, Kasongo, Christian Mabika, Keffers, Sophie, Kekana, Boitumelo Sophy, Kekana, Sebaetseng Jeanette, Kelepu, Xoliswa, Khanyile, Lungile, Khobedi, Gomotsegang Virginia, Khomba, Gloria, Khoza, Lucky Sipho, King, Marietjie, Kolobe, Gloria Keitumetse, Kruger, Sandra, Kruger, Jaftha, Kunene, Ndlela Israel, Lakay, Sunelza, Lakhi, Aneesa, Langa, Nondumiso, Ledwaba, Hildah, Lekagane, Lerato Julia, Lekotloane, Sheiley Christina, Leopeng, Thelma, Louw, Ilze Jeanette, Luabeya, Angelique Kany Kany, Lusale, Sarah Teboso, Maatjie, Perfect Tiisetso, Mabasa, Immaculate, Mabe, Tshegofatso Dorah, Mabena, Kamogelo Fortunate, Mabuza, Nkosinathi Charles, Mabwe, Simbarashe, Madikwe, Johanna Thapelo, Madikwe, Octavia Mahkosazana, Maebana, Rapontwana Letlhogonolo, Magwasha, Malobisa Sylvester, Majola, Molly, Makhetha, Mantai, Makhethe, Lebohang, Malay, Vernon, Manzini, Vutlhari-I-Vunhenha Fairlord, Maphanga, Jabu, Maphanga, Nonhle, Market, Juanita, Maroele, Isholedi Samuel, Masibi, Omphile Petunia, Mathabanzini, July Rocky, Mathode, Tendamudzimu Ivan, Matsane, Ellen Ditaba, Mbata, Lungile, Meyer, Faheema, Mhandire, Nyasha Karen, Miga, Thembisiwe, Mkhize, Nosisa Charity Thandeka, Mkhokho, Caroline, Mkwalase, Neo Hilda, Mnqonywa, Nondzakazi, Moche, Karabo, Modisaotsile, Brenda Matshidiso, Mokgetsengoane, Patricia Pakiso, Mokone, Selemeng Matseliso Carol, Molatlhegi, Kegomoditswe Magdeline, Molefe, Thuso Andrew, Moloko, Joseph Panie, Molosi, Kabelo, Molotsi, Motlatsi Evelyn, Montwedi, Tebogo Edwin, Monyemangene, Boikanyo Dinah, Mooketsi, Hellen Mokopi, Moses, Miriam, Mosito, Boitumelo, Mosito, Tshplpfelo Mapula, Mosweu, Ireen Lesebang, Mothaga, Primrose, Motlagomang, Banyana Olga, Mouton, Angelique, Mpofu, Onesisa, Mthembu, Funeka Nomvula, Mtlali, Mpho, Ndlovu, Nhlamulo, Ngcobo, Nompumelelo, Noble, Julia, Ntamo, Bantubonke Bertrum, Ntanjana, Gloria, Ntshauba, Tedrius, Opperman, Fajwa, Padayatchi, Nesri, Papalagae, Thandiwe, Petersen, Christel, Phakathi, Themba, Phatshwane, Mapule Ozma, Plaatjie, Patiswa, Pretorius, Abe, Rameetse, Victor Kgothatso, Ramjit, Dirhona, Ratangee, Frances, Ratangee, Maigan, Sanyaka, Pearl Nomsa, Sato, Alicia, Schoeman, Elisma, Schreuder, Constance, Seabela, Letlhogonolo, Segaetsho, Kelebogile Magdeline, Sein, Ni Ni, Selepe, Raesibe Agnes Pearl, Senne, Melissa Neo, September, Alison, September, Cashwin, Serake, Moeti, Shenje, Justin, Shezi, Thandiwe, Shezi, Sifiso Cornelius, Sing, Phindile, Singh, Chandrapharbha, Sithetho, Zona, Solomons, Dorothy, Stanley, Kim, Steyn, Marcia, Stofile, Bongiwe, Stryers, Sonia, Swanepoel, Liticia, Swarts, Anne, Thaba, Mando Mmakhora, Theko, Lethabo Collen, Thembela, Philile, Thompo, Mugwena, Toefy, Asma, Toto, Khayalethu, Tsagae, Dimakatso Sylvia, Tsamane, Ayanda, Tshikovhi, Vincent, Tswaile, Lebogang Isaac, Tyambetyu, Petrus, Tönsing, Susanne, Valley, Habibullah, van der Merwe, Linda, van Rooyen, Elma, Veldsman, Ashley, Veldtsman, Helen, Vollenhoven, Kelvin, Zaca, Londiwe, Zimri, Elaine, Zulu, Mbali, Mendelsohn, Simon C, Fiore-Gartland, Andrew, Penn-Nicholson, Adam, Mulenga, Humphrey, Mbandi, Stanley Kimbung, Borate, Bhavesh, Hadley, Katie, Hikuam, Chris, Musvosvi, Munyaradzi, Bilek, Nicole, Erasmus, Mzwandile, Jaxa, Lungisa, Raphela, Rodney, Nombida, Onke, Kaskar, Masooda, Sumner, Tom, White, Richard G, Innes, Craig, Brumskine, William, Hiemstra, Andriëtte, Malherbe, Stephanus T, Hassan-Moosa, Razia, Tameris, Michèle, Walzl, Gerhard, Naidoo, Kogieleum, Churchyard, Gavin, Scriba, Thomas J, and Hatherill, Mark

Published
2021
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4. Safety and immunogenicity of the adjunct therapeutic vaccine ID93 + GLA-SE in adults who have completed treatment for tuberculosis: a randomised, double-blind, placebo-controlled, phase 2a trial

Author

Beckmann, Anna Marie, Hsu, Fan-Chi, Albertson, Sarah, Veldsman, Ashley, Schreuder, Constance, Smit, Erica, Cloete, Yolundi, Ontong, Cynthia, Filander, Elisabeth, Jacobs, Gail, Keyser, Alana, Africa, Hadn, Mulenga, Humphrey, Noble, Julia, Makhethe, Lebohang, Steyn, Marcia, de Kock, Marwou, Quaqua, Nambitha, Lu, Yiwen, Gutschmidt, Andrea, Thienemann, Friedrich, Kahn, Stuart, Mouton, Angelique, Van Rooyen, Elma, Opperman, Fajwa, Swarts, Ann, Van Schalkwyk, Amaryl, Herselman, Yolandi, Hofmeester, Devona, Amsterdam, Julia, Hassanally, Leya, van der Merwe, Linda, Companie, Alessandro, Rossouw, Susan, Jones, Carolyn, Botes, Natasja, van der Riet, Elize, Goliath, Sandra, Kruger, Sandra, Sinandile, Eunice, Day, Tracey A, Penn-Nicholson, Adam, Luabeya, Angelique Kany Kany, Fiore-Gartland, Andrew, Du Plessis, Nelita, Loxton, Andre G, Vergara, Julie, Rolf, Tom A, Reid, Tim D, Toefy, Asma, Shenje, Justin, Geldenhuys, Hendrik, Tameris, Michele, Mabwe, Simbarashe, Bilek, Nicole, Bekker, Linda-Gail, Diacon, Andreas, Walzl, Gerhard, Ashman, Jill, Frevol, Aude, Sagawa, Zachary K, Lindestam Arlehamn, Cecilia, Sette, Alessandro, Reed, Steven G, Coler, Rhea N, Scriba, Thomas J, and Hatherill, Mark

Published
2021
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5. Biomarker-guided tuberculosis preventive therapy (CORTIS): a randomised controlled trial

Author

Baepanye, Kesenogile, Baepanye, Tshepiso, Clarke, Ken, Collignon, Marelize, Dlamini, Audrey, Eyre, Candice, Feni, Tebogo, Fikizolo, Moogo, Galane, Phinda, Goliath, Thelma, Gangat, Alia, Malefo-Grootboom, Shirley, Janse van Rensburg, Elba, Janse van Rensburg, Bonita, Kekana, Sophy, Zietsman, Marietjie, Kock, Adrianne, Kunene, Israel, Lakhi, Aneessa, Langa, Nondumiso, Ledwaba, Hilda, Luphoko, Marillyn, Mabasa, Immaculate, Mabe, Dorah, Mabuza, Nkosinathi, Majola, Molly, Makhetha, Mantai, Makoanyane, Mpho, Makhubalo, Blossom, Malay, Vernon, Market, Juanita, Matshego, Selvy, Mbipa, Nontsikelelo, Mmotsa, Tsiamo, Modipa, Sylvester, Mopati, Samuel, Moswegu, Palesa, Mothaga, Primrose, Muller, Dorothy, Nchwe, Grace, Nel, Maryna, Nhlangulela, Lindiwe, Ntamo, Bantubonke, Ntoahae, Lawerence, Ntshauba, Tedrius, Sanyaka, Nomsa, Seabela, Letlhogonolo, Selepe, Pearl, Senne, Melissa, Serake, MG, Thlapi, Maria, Tshikovhi, Vincent, Tswaile, Lebogang, van Aswegen, Amanda, Mbata, Lungile, Takavamanya, Constance, Pinho, Pedro, Mdlulu, John, Taljaard, Marthinette, Slabbert, Naydene, Sayed, Sharfuddin, Nielson, Tanya, Ni Sein, Ni, Govender, Dhineshree, Chinappa, Tilagavathy, Zulu, Mbali Ignatia, Maphanga, Nonhle Bridgette, Hlathi, Senzo Ralph, Gumede, Goodness Khanyisile, Shezi, Thandiwe Yvonne, Maphanga, Jabulisiwe Lethabo, Jali, Zandile Patrica, Cwele, Thobelani, Gwamanda, Nonhlanhla Zanele Elsie, Dlamini, Celaphiwe, Sing, Zibuyile Phindile Penlee, Ntanjana, Ntombozuko Gloria, Nzimande, Sphelele Simo, Mbatha, Siyabonga, Maharaj, Bhavna, Moosa, Atika, Corris, Cara-Mia, Kafaar, Fazlin, Geldenhuys, Hennie, Luabeya, Angelique Kany Kany, Shenje, Justin, Botes, Natasja, Rossouw, Susan, Africa, Hadn, Diamond, Bongani, Braaf, Samentra, Stryers, Sonia, Carstens, Alida, Jansen, Ruwiyda, Mabwe, Simbarashe, Mulenga, Humphrey, Herling, Roxane, Veldsman, Ashley, Makhete, Lebohgang, Steyn, Marcia, Buhlungu, Sivuyile, Erasmus, Margareth, Davids, Ilse, Plaatjie, Patiswa, Companie, Alessandro, Ratangee, Frances, Veldtsman, Helen, Petersen, Christel, Abrahams, Charmaine, Moses, Miriam, Kelepu, Xoliswa, Gregg, Yolande, Swanepoel, Liticia, Magawu, Nomsitho, Cetywayo, Nompumelelo, Mactavie, Lauren, Valley, Habibullah, Filander, Elizabeth, Nqakala, Nambitha, Maasdorp, Elizna, Khoury, Justine, Kriel, Belinda, Smith, Bronwyn, Muller, Liesel, Tonsing, Susanne, Loxton, Andre, Hiemstra, Andriette, Ahlers, Petri, Flinn, Marika, Chung, Eva, Chung, Michelle, Sato, Alicia, Scriba, Thomas J, Fiore-Gartland, Andrew, Penn-Nicholson, Adam, Kimbung Mbandi, Stanley, Borate, Bhavesh, Mendelsohn, Simon C, Hadley, Katie, Hikuam, Chris, Kaskar, Masooda, Musvosvi, Munyaradzi, Bilek, Nicole, Self, Steven, Sumner, Tom, White, Richard G, Erasmus, Mzwandile, Jaxa, Lungisa, Raphela, Rodney, Innes, Craig, Brumskine, William, Hiemstra, Andriëtte, Malherbe, Stephanus T, Hassan-Moosa, Razia, Tameris, Michèle, Walzl, Gerhard, Naidoo, Kogieleum, Churchyard, Gavin, and Hatherill, Mark

Published
2021
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6. Live-attenuated Mycobacterium tuberculosis vaccine MTBVAC versus BCG in adults and neonates: a randomised controlled, double-blind dose-escalation trial

Author

Africa, Hadn, Arendsen, Denis, Botes, Natasja, Cloete, Yolundi, De Kock, Marwou, Erasmus, Margaret, Jack, Lungisa, Kafaar, Fazlin, Kalepu, Xoliswa, Khomba, Nondumiso Gloria, Kruger, Sandra, Leopeng, Thelma, Makhethe, Lebohang, Mouton, Angelique, Mulenga, Humphrey, Musvosvi, Munyaradzi, Noble, Julia, Opperman, Fajwa, Reid, Tim, Rossouw, Susan, Schreuder, Constance, Smit, Erica, Steyn, Marcia, Tyambethu, Petrus, Van Rooyen, Elma, Veldsman, Ashley, Tameris, Michele, Mearns, Helen, Penn-Nicholson, Adam, Gregg, Yolande, Bilek, Nicole, Mabwe, Simbarashe, Geldenhuys, Hennie, Shenje, Justin, Luabeya, Angelique Kany Kany, Murillo, Ingrid, Doce, Juana, Aguilo, Nacho, Marinova, Dessislava, Puentes, Eugenia, Rodríguez, Esteban, Gonzalo-Asensio, Jesús, Fritzell, Bernard, Thole, Jelle, Martin, Carlos, Scriba, Thomas J, and Hatherill, Mark

Published
2019
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7. The novel tuberculosis vaccine, AERAS-402, is safe in healthy infants previously vaccinated with BCG, and induces dose-dependent CD4 and CD8T cell responses

Author

Mansoor, Nazma, Hughes, Jane, de Kock, Marwou, Whatney, Wendy, Africa, Hadn, Krohn, Colleen, Veldsman, Ashley, Kany, Angelique Luabeya Kany, Douoguih, Macaya, Pau, Maria Grazia, Hendriks, Jenny, McClain, Bruce, Benko, Jacqueline, Snowden, Margaret A., Hokey, David A., Kagina, Benjamin M.N., Tameris, Michele D., Geldenhuys, Hennie, Hatherill, Mark, Abel, Brian, Hussey, Gregory D., Scriba, Thomas J., Mahomed, Hassan, Sadoff, Jerald C., and Hanekom, Willem A.

Published
2014
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8. Dose-Finding Study of the Novel Tuberculosis Vaccine, MVA85A, in Healthy BCG-Vaccinated Infants

Author

Scriba, Thomas J., Tameris, Michèle, Mansoor, Nazma, Smit, Erica, van der Merwe, Linda, Mauff, Katya, Hughes, E.Jane, Moyo, Sizulu, Brittain, Nathaniel, Lawrie, Alison, Mulenga, Humphrey, de Kock, Marwou, Gelderbloem, Sebastian, Veldsman, Ashley, Hatherill, Mark, Geldenhuys, Hendrik, Hill, Adrian V.S., Hussey, Gregory D., Mahomed, Hassan, Hanekom, Willem A., and McShane, Helen

Published
2011
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10. Validation of a host blood transcriptomic biomarker for pulmonary tuberculosis in people living with HIV: a prospective diagnostic and prognostic accuracy study

Author

Mendelsohn, Simon C, primary, Fiore-Gartland, Andrew, additional, Penn-Nicholson, Adam, additional, Mulenga, Humphrey, additional, Mbandi, Stanley Kimbung, additional, Borate, Bhavesh, additional, Hadley, Katie, additional, Hikuam, Chris, additional, Musvosvi, Munyaradzi, additional, Bilek, Nicole, additional, Erasmus, Mzwandile, additional, Jaxa, Lungisa, additional, Raphela, Rodney, additional, Nombida, Onke, additional, Kaskar, Masooda, additional, Sumner, Tom, additional, White, Richard G, additional, Innes, Craig, additional, Brumskine, William, additional, Hiemstra, Andriëtte, additional, Malherbe, Stephanus T, additional, Hassan-Moosa, Razia, additional, Tameris, Michèle, additional, Walzl, Gerhard, additional, Naidoo, Kogieleum, additional, Churchyard, Gavin, additional, Scriba, Thomas J, additional, Hatherill, Mark, additional, Abrahams, Charmaine, additional, Africa, Hadn, additional, Ahlers, Petri, additional, Arendsen, Denis, additional, Badimo, Tebogo, additional, Baepanye, Kagiso, additional, Baepanye, Kesenogile Edna, additional, Bande, Bianca, additional, Batyi, Nomfuneko Cynthia, additional, Beukes, Roslyn, additional, Bontsi, Laudicia Tshenolo, additional, Booi, Obakeng Peter, additional, Botha, Mari Cathrin, additional, Braaf, Samentra, additional, Buhlungu, Sivuyile, additional, Carstens, Alida, additional, Chauke, Kgomotso Violet, additional, Chinappa, Thilagavathy, additional, Chung, Eva, additional, Chung, Michelle, additional, Clarke, Ken, additional, Cloete, Yolundi, additional, Coetzee, Lorraine, additional, Collignon, Marelize, additional, Companie, Alessandro, additional, Corris, Cara-mia, additional, Cwaile, Mooketsi Theophillius, additional, Cwele, Thobelani, additional, Davids, Ilse, additional, Davies, Isabella Johanna, additional, De Klerk, Emilia, additional, de Kock, Marwou, additional, Dhlamini, Audrey Lebohang, additional, Diamond, Bongani, additional, Didloff, Maria, additional, Dlamini, Celaphiwe, additional, Dolo, Palesa, additional, Eyre, Candice, additional, Feni, Tebogo, additional, Ferreira, Juanita, additional, Ferus, Christal, additional, Fisher, Michelle, additional, Flinn, Marika, additional, Fransman, Bernadine, additional, Galane, Welseh Phindile, additional, Geldenhuys, Hennie, additional, Gempies, Diann, additional, Goliath, Thelma, additional, Govender, Dhineshree, additional, Gregg, Yolande, additional, Gumede, Goodness, additional, Gwamada, Zanele, additional, Halti, Senzo, additional, Hassiem, Rieyaat, additional, Herling, Roxane, additional, Herselman, Yulandi, additional, Hughes, Ellis, additional, Issel, Henry, additional, Iyemosolo, Blanchard Mbay, additional, Jali, Zandile, additional, Janse Van Rensburg, Bonita, additional, Jansen, Ruwiyda, additional, Jeleni, James Michael, additional, Jonkane, Olebogeng, additional, Julies, Fabio, additional, Kafaar, Fazlin, additional, Kasongo, Christian Mabika, additional, Keffers, Sophie, additional, Kekana, Boitumelo Sophy, additional, Kekana, Sebaetseng Jeanette, additional, Kelepu, Xoliswa, additional, Khanyile, Lungile, additional, Khobedi, Gomotsegang Virginia, additional, Khomba, Gloria, additional, Khoza, Lucky Sipho, additional, King, Marietjie, additional, Kolobe, Gloria Keitumetse, additional, Kruger, Sandra, additional, Kruger, Jaftha, additional, Kunene, Ndlela Israel, additional, Lakay, Sunelza, additional, Lakhi, Aneesa, additional, Langa, Nondumiso, additional, Ledwaba, Hildah, additional, Lekagane, Lerato Julia, additional, Lekotloane, Sheiley Christina, additional, Leopeng, Thelma, additional, Louw, Ilze Jeanette, additional, Luabeya, Angelique Kany Kany, additional, Lusale, Sarah Teboso, additional, Maatjie, Perfect Tiisetso, additional, Mabasa, Immaculate, additional, Mabe, Tshegofatso Dorah, additional, Mabena, Kamogelo Fortunate, additional, Mabuza, Nkosinathi Charles, additional, Mabwe, Simbarashe, additional, Madikwe, Johanna Thapelo, additional, Madikwe, Octavia Mahkosazana, additional, Maebana, Rapontwana Letlhogonolo, additional, Magwasha, Malobisa Sylvester, additional, Majola, Molly, additional, Makhetha, Mantai, additional, Makhethe, Lebohang, additional, Malay, Vernon, additional, Manzini, Vutlhari-I-Vunhenha Fairlord, additional, Maphanga, Jabu, additional, Maphanga, Nonhle, additional, Market, Juanita, additional, Maroele, Isholedi Samuel, additional, Masibi, Omphile Petunia, additional, Mathabanzini, July Rocky, additional, Mathode, Tendamudzimu Ivan, additional, Matsane, Ellen Ditaba, additional, Mbata, Lungile, additional, Meyer, Faheema, additional, Mhandire, Nyasha Karen, additional, Miga, Thembisiwe, additional, Mkhize, Nosisa Charity Thandeka, additional, Mkhokho, Caroline, additional, Mkwalase, Neo Hilda, additional, Mnqonywa, Nondzakazi, additional, Moche, Karabo, additional, Modisaotsile, Brenda Matshidiso, additional, Mokgetsengoane, Patricia Pakiso, additional, Mokone, Selemeng Matseliso Carol, additional, Molatlhegi, Kegomoditswe Magdeline, additional, Molefe, Thuso Andrew, additional, Moloko, Joseph Panie, additional, Molosi, Kabelo, additional, Molotsi, Motlatsi Evelyn, additional, Montwedi, Tebogo Edwin, additional, Monyemangene, Boikanyo Dinah, additional, Mooketsi, Hellen Mokopi, additional, Moses, Miriam, additional, Mosito, Boitumelo, additional, Mosito, Tshplpfelo Mapula, additional, Mosweu, Ireen Lesebang, additional, Mothaga, Primrose, additional, Motlagomang, Banyana Olga, additional, Mouton, Angelique, additional, Mpofu, Onesisa, additional, Mthembu, Funeka Nomvula, additional, Mtlali, Mpho, additional, Ndlovu, Nhlamulo, additional, Ngcobo, Nompumelelo, additional, Noble, Julia, additional, Ntamo, Bantubonke Bertrum, additional, Ntanjana, Gloria, additional, Ntshauba, Tedrius, additional, Opperman, Fajwa, additional, Padayatchi, Nesri, additional, Papalagae, Thandiwe, additional, Petersen, Christel, additional, Phakathi, Themba, additional, Phatshwane, Mapule Ozma, additional, Plaatjie, Patiswa, additional, Pretorius, Abe, additional, Rameetse, Victor Kgothatso, additional, Ramjit, Dirhona, additional, Ratangee, Frances, additional, Ratangee, Maigan, additional, Sanyaka, Pearl Nomsa, additional, Sato, Alicia, additional, Schoeman, Elisma, additional, Schreuder, Constance, additional, Seabela, Letlhogonolo, additional, Segaetsho, Kelebogile Magdeline, additional, Sein, Ni Ni, additional, Selepe, Raesibe Agnes Pearl, additional, Senne, Melissa Neo, additional, September, Alison, additional, September, Cashwin, additional, Serake, Moeti, additional, Shenje, Justin, additional, Shezi, Thandiwe, additional, Shezi, Sifiso Cornelius, additional, Sing, Phindile, additional, Singh, Chandrapharbha, additional, Sithetho, Zona, additional, Solomons, Dorothy, additional, Stanley, Kim, additional, Steyn, Marcia, additional, Stofile, Bongiwe, additional, Stryers, Sonia, additional, Swanepoel, Liticia, additional, Swarts, Anne, additional, Thaba, Mando Mmakhora, additional, Theko, Lethabo Collen, additional, Thembela, Philile, additional, Thompo, Mugwena, additional, Toefy, Asma, additional, Toto, Khayalethu, additional, Tsagae, Dimakatso Sylvia, additional, Tsamane, Ayanda, additional, Tshikovhi, Vincent, additional, Tswaile, Lebogang Isaac, additional, Tyambetyu, Petrus, additional, Tönsing, Susanne, additional, Valley, Habibullah, additional, van der Merwe, Linda, additional, van Rooyen, Elma, additional, Veldsman, Ashley, additional, Veldtsman, Helen, additional, Vollenhoven, Kelvin, additional, Zaca, Londiwe, additional, Zimri, Elaine, additional, and Zulu, Mbali, additional

Published
2021
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11. Safety and immunogenicity of the adjunct therapeutic vaccine ID93 + GLA-SE in adults who have completed treatment for tuberculosis: a randomised, double-blind, placebo-controlled, phase 2a trial

Author

Day, Tracey A, primary, Penn-Nicholson, Adam, additional, Luabeya, Angelique Kany Kany, additional, Fiore-Gartland, Andrew, additional, Du Plessis, Nelita, additional, Loxton, Andre G, additional, Vergara, Julie, additional, Rolf, Tom A, additional, Reid, Tim D, additional, Toefy, Asma, additional, Shenje, Justin, additional, Geldenhuys, Hendrik, additional, Tameris, Michele, additional, Mabwe, Simbarashe, additional, Bilek, Nicole, additional, Bekker, Linda-Gail, additional, Diacon, Andreas, additional, Walzl, Gerhard, additional, Ashman, Jill, additional, Frevol, Aude, additional, Sagawa, Zachary K, additional, Lindestam Arlehamn, Cecilia, additional, Sette, Alessandro, additional, Reed, Steven G, additional, Coler, Rhea N, additional, Scriba, Thomas J, additional, Hatherill, Mark, additional, Beckmann, Anna Marie, additional, Hsu, Fan-Chi, additional, Albertson, Sarah, additional, Veldsman, Ashley, additional, Schreuder, Constance, additional, Smit, Erica, additional, Cloete, Yolundi, additional, Ontong, Cynthia, additional, Filander, Elisabeth, additional, Jacobs, Gail, additional, Keyser, Alana, additional, Africa, Hadn, additional, Mulenga, Humphrey, additional, Noble, Julia, additional, Makhethe, Lebohang, additional, Steyn, Marcia, additional, de Kock, Marwou, additional, Quaqua, Nambitha, additional, Lu, Yiwen, additional, Gutschmidt, Andrea, additional, Thienemann, Friedrich, additional, Kahn, Stuart, additional, Mouton, Angelique, additional, Van Rooyen, Elma, additional, Opperman, Fajwa, additional, Swarts, Ann, additional, Van Schalkwyk, Amaryl, additional, Herselman, Yolandi, additional, Hofmeester, Devona, additional, Amsterdam, Julia, additional, Hassanally, Leya, additional, van der Merwe, Linda, additional, Companie, Alessandro, additional, Rossouw, Susan, additional, Jones, Carolyn, additional, Botes, Natasja, additional, van der Riet, Elize, additional, Goliath, Sandra, additional, Kruger, Sandra, additional, and Sinandile, Eunice, additional

Published
2021
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12. Biomarker-guided tuberculosis preventive therapy (CORTIS): a randomised controlled trial

Author

Scriba, Thomas J, primary, Fiore-Gartland, Andrew, additional, Penn-Nicholson, Adam, additional, Mulenga, Humphrey, additional, Kimbung Mbandi, Stanley, additional, Borate, Bhavesh, additional, Mendelsohn, Simon C, additional, Hadley, Katie, additional, Hikuam, Chris, additional, Kaskar, Masooda, additional, Musvosvi, Munyaradzi, additional, Bilek, Nicole, additional, Self, Steven, additional, Sumner, Tom, additional, White, Richard G, additional, Erasmus, Mzwandile, additional, Jaxa, Lungisa, additional, Raphela, Rodney, additional, Innes, Craig, additional, Brumskine, William, additional, Hiemstra, Andriëtte, additional, Malherbe, Stephanus T, additional, Hassan-Moosa, Razia, additional, Tameris, Michèle, additional, Walzl, Gerhard, additional, Naidoo, Kogieleum, additional, Churchyard, Gavin, additional, Hatherill, Mark, additional, Baepanye, Kesenogile, additional, Baepanye, Tshepiso, additional, Clarke, Ken, additional, Collignon, Marelize, additional, Dlamini, Audrey, additional, Eyre, Candice, additional, Feni, Tebogo, additional, Fikizolo, Moogo, additional, Galane, Phinda, additional, Goliath, Thelma, additional, Gangat, Alia, additional, Malefo-Grootboom, Shirley, additional, Janse van Rensburg, Elba, additional, Janse van Rensburg, Bonita, additional, Kekana, Sophy, additional, Zietsman, Marietjie, additional, Kock, Adrianne, additional, Kunene, Israel, additional, Lakhi, Aneessa, additional, Langa, Nondumiso, additional, Ledwaba, Hilda, additional, Luphoko, Marillyn, additional, Mabasa, Immaculate, additional, Mabe, Dorah, additional, Mabuza, Nkosinathi, additional, Majola, Molly, additional, Makhetha, Mantai, additional, Makoanyane, Mpho, additional, Makhubalo, Blossom, additional, Malay, Vernon, additional, Market, Juanita, additional, Matshego, Selvy, additional, Mbipa, Nontsikelelo, additional, Mmotsa, Tsiamo, additional, Modipa, Sylvester, additional, Mopati, Samuel, additional, Moswegu, Palesa, additional, Mothaga, Primrose, additional, Muller, Dorothy, additional, Nchwe, Grace, additional, Nel, Maryna, additional, Nhlangulela, Lindiwe, additional, Ntamo, Bantubonke, additional, Ntoahae, Lawerence, additional, Ntshauba, Tedrius, additional, Sanyaka, Nomsa, additional, Seabela, Letlhogonolo, additional, Selepe, Pearl, additional, Senne, Melissa, additional, Serake, MG, additional, Thlapi, Maria, additional, Tshikovhi, Vincent, additional, Tswaile, Lebogang, additional, van Aswegen, Amanda, additional, Mbata, Lungile, additional, Takavamanya, Constance, additional, Pinho, Pedro, additional, Mdlulu, John, additional, Taljaard, Marthinette, additional, Slabbert, Naydene, additional, Sayed, Sharfuddin, additional, Nielson, Tanya, additional, Ni Sein, Ni, additional, Govender, Dhineshree, additional, Chinappa, Tilagavathy, additional, Zulu, Mbali Ignatia, additional, Maphanga, Nonhle Bridgette, additional, Hlathi, Senzo Ralph, additional, Gumede, Goodness Khanyisile, additional, Shezi, Thandiwe Yvonne, additional, Maphanga, Jabulisiwe Lethabo, additional, Jali, Zandile Patrica, additional, Cwele, Thobelani, additional, Gwamanda, Nonhlanhla Zanele Elsie, additional, Dlamini, Celaphiwe, additional, Sing, Zibuyile Phindile Penlee, additional, Ntanjana, Ntombozuko Gloria, additional, Nzimande, Sphelele Simo, additional, Mbatha, Siyabonga, additional, Maharaj, Bhavna, additional, Moosa, Atika, additional, Corris, Cara-Mia, additional, Kafaar, Fazlin, additional, Geldenhuys, Hennie, additional, Luabeya, Angelique Kany Kany, additional, Shenje, Justin, additional, Botes, Natasja, additional, Rossouw, Susan, additional, Africa, Hadn, additional, Diamond, Bongani, additional, Braaf, Samentra, additional, Stryers, Sonia, additional, Carstens, Alida, additional, Jansen, Ruwiyda, additional, Mabwe, Simbarashe, additional, Herling, Roxane, additional, Veldsman, Ashley, additional, Makhete, Lebohgang, additional, Steyn, Marcia, additional, Buhlungu, Sivuyile, additional, Erasmus, Margareth, additional, Davids, Ilse, additional, Plaatjie, Patiswa, additional, Companie, Alessandro, additional, Ratangee, Frances, additional, Veldtsman, Helen, additional, Petersen, Christel, additional, Abrahams, Charmaine, additional, Moses, Miriam, additional, Kelepu, Xoliswa, additional, Gregg, Yolande, additional, Swanepoel, Liticia, additional, Magawu, Nomsitho, additional, Cetywayo, Nompumelelo, additional, Mactavie, Lauren, additional, Valley, Habibullah, additional, Filander, Elizabeth, additional, Nqakala, Nambitha, additional, Maasdorp, Elizna, additional, Khoury, Justine, additional, Kriel, Belinda, additional, Smith, Bronwyn, additional, Muller, Liesel, additional, Tonsing, Susanne, additional, Loxton, Andre, additional, Hiemstra, Andriette, additional, Ahlers, Petri, additional, Flinn, Marika, additional, Chung, Eva, additional, Chung, Michelle, additional, and Sato, Alicia, additional

Published
2021
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13. Live-attenuated Mycobacterium tuberculosis vaccine MTBVAC versus BCG in adults and neonates: a randomised controlled, double-blind dose-escalation trial

Author

Tameris, Michele, Mearns, Helen, Penn-Nicholson, Adam, Gregg, Yolande, Bilek, Nicole, Mabwe, Simbarashe, Geldenhuys, Hennie, Shenje, Justin, Luabeya, Angelique Kany K., Murillo, Ingrid, Doce, Juana, Aguilo, Nacho, Marinova, Dessislava, Puentes, Eugenia, Rodríguez, Esteban, Gonzalo-Asensiom, Jesús, Fritzell, Bernard, Thole, Jelle, Martin, Carlos, Scriba, Thomas J., Hatherill, Mark, Africa, Hadn, Arendsen, Denis, Botes, Natasja, Cloete, Yolundi, De Kock, Marwou, Erasmus, Margaret, Jack, Lungisa, Kafaar, Fazlin, Kalepu, Xoliswa, Khomba, Nondumiso Gloria, Kruger, Sandra, Leopeng, Thelma, Makhethe, Lebohang, Mouton, Angelique, Mulenga, Humphrey, Musvosvi, Munyaradzi, Noble, Julia, Opperman, Fajwa, Reid, Tim, Rossouw, Susan, Schreuder, Constance, Smit, Erica, Steyn, Marcia, Tyambethu, Petrus, Van Rooyen, Elma, Veldsman, Ashley, and MTBVAC Clinical Trial Team

Abstract

Background: Infants are a key target population for new tuberculosis vaccines. We assessed the safety and immunogenicity of the live-attenuated Mycobacterium tuberculosis vaccine candidate MTBVAC in adults and infants in a region where transmission of tuberculosis is very high. Methods: We did a randomised, double-blind, BCG-controlled, dose-escalation trial at the South African Tuberculosis Vaccine Initiative site near Cape Town, South Africa. Healthy adult community volunteers who were aged 18–50 years, had received BCG vaccination as infants, were HIV negative, had negative interferon-¿ release assay (IGRA) results, and had no personal history of tuberculosis or current household contact with someone with tuberculosis were enrolled in a safety cohort. Infants born to HIV-negative women with no personal history of tuberculosis or current household contact with a person with tuberculosis and who were 96 h old or younger, generally healthy, and had not yet received routine BCG vaccination were enrolled in a separate infant cohort. Eligible adults were randomly assigned (1:1) to receive either BCG Vaccine SSI (5 × 105 colony forming units [CFU] of Danish strain 1331 in 0·1 mL diluent) or MTBVAC (5 × 105 CFU in 0·1 mL) intradermally in the deltoid region of the arm. After favourable review of 28-day reactogenicity and safety data in the adult cohort, infants were randomly assigned (1:3) to receive either BCG Vaccine SSI (2·5 × 105 CFU in 0·05 mL diluent) or MTBVAC in three sequential cohorts of increasing MTBVAC dose (2·5 × 103 CFU, 2·5 × 104 CFU, and 2·5 × 105 CFU in 0·05 mL) intradermally in the deltoid region of the arm. QuantiFERON-TB Gold In-Tube IGRA was done on days 180 and 360. For both randomisations, a pre-prepared block randomisation schedule was used. Participants (and their parents or guardians in the case of infant participants), investigators, and other clinical and laboratory staff were masked to intervention allocation. The primary outcomes, which were all measured in the infant cohort, were solicited and unsolicited local adverse events and serious adverse events until day 360; non-serious systemic adverse events until day 28 and vaccine-specific CD4 and CD8 T-cell responses on days 7, 28, 70, 180, and 360. Secondary outcomes measured in adults were local injection-site and systemic reactions and haematology and biochemistry at study day 7 and 28. Safety analyses and immunogenicity analyses were done in all participants who received a dose of vaccine. This trial is registered with ClinicalTrials.gov, number NCT02729571. Findings: Between Sept 29, 2015, and Nov 16, 2015, 62 adults were screened and 18 were enrolled and randomly assigned, nine each to the BCG and MTBVAC groups. Between Feb 12, 2016, and Sept 21, 2016, 36 infants were randomly assigned—eight to the BCG group, nine to the 2·5 × 103 CFU MTBVAC group, nine to the 2·5 × 104 CFU group, and ten to the 2·5 × 105 CFU group. Mild injection-site reactions occurred only in infants in the BCG and the 2·5 × 105 CFU MTBVAC group, with no evidence of local or regional injection-site complications. Systemic adverse events were evenly distributed across BCG and MTBVAC dose groups, and were mostly mild in severity. Eight serious adverse events were reported in seven vaccine recipients (one adult MTBVAC recipient, one infant BCG recipient, one infant in the 2·5 × 103 CFU MTBVAC group, two in the 2·5 × 104 CFU MTBVAC group, and two in the 2·5 × 105 CFU MTBVAC group), including one infant in the 2·5 × 103 CFU MTBVAC group treated for unconfirmed tuberculosis and one in the 2·5 × 105 CFU MTBVAC group treated for unlikely tuberculosis. One infant died as a result of possible viral pneumonia. Vaccination with all MTBVAC doses induced durable antigen-specific T-helper-1 cytokine-expressing CD4 cell responses in infants that peaked 70 days after vaccination and were detectable 360 days after vaccination. For the highest MTBVAC dose (ie, 2·5 × 105 CFU), these responses exceeded responses induced by an equivalent dose of the BCG vaccine up to 360 days after vaccination. Dose-related IGRA conversion was noted in three (38%) of eight infants in the 2·5 × 103 CFU MTBVAC group, six (75%) of eight in the 2·5 × 104 CFU MTBVAC group, and seven (78%) of nine in the 2·5 × 105 CFU MTBVAC group at day 180, compared with none of seven infants in the BCG group. By day 360, IGRA reversion had occurred in all three infants (100%) in the 2·5 × 103 CFU MTBVAC group, four (67%) of the six in the 2·5 × 104 CFU MTBVAC group, and three (43%) of the seven in the 2·5 × 105 CFU MTBVAC group. Interpretation: MTBVAC had acceptable reactogenicity, and induced a durable CD4 cell response in infants. The evidence of immunogenicity supports progression of MTBVAC into larger safety and efficacy trials, but also confounds interpretation of tests for M tuberculosis infection, highlighting the need for stringent endpoint definition. Funding: Norwegian Agency for Development Cooperation, TuBerculosis Vaccine Initiative, UK Department for International Development, and Biofabri.

Published
2020

14. A Phase IIa Trial of the New Tuberculosis Vaccine, MVA85A, in HIV- and/or Mycobacterium tuberculosis-infected Adults

Author

Scriba, Thomas J., Tameris, Michele, Smit, Erica, van der Merwe, Linda, Hughes, Jane E., Kadira, Blessing, Mauff, Katya, Moyo, Sizulu, Brittain, Nathaniel, Lawrie, Alison, Mulenga, Humphrey, de Kock, Marwou, Makhethe, Lebohang, van Rensburg, Esme Janse, Gelderbloem, Sebastian, Veldsman, Ashley, Hatherill, Mark, Geldenhuys, Hendrik, Hill, Adrian V. S., Hawkridge, Anthony, Hussey, Gregory D., Hanekom, Willem A., McShane, Helen, and Mahomed, Hassan

Published
2012
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15. The Novel Tuberculosis Vaccine, AERAS-402, Induces Robust and Polyfunctional CD4+ and CD8+ T Cells in Adults

Author

Abel, Brian, Tameris, Michele, Mansoor, Nazma, Gelderbloem, Sebastian, Hughes, Jane, Abrahams, Deborah, Makhethe, Lebohang, Erasmus, Mzwandile, de Kock, Marwou, van der Merwe, Linda, Hawkridge, Anthony, Veldsman, Ashley, Hatherill, Mark, Schirru, Giulia, Pau, Maria Grazia, Hendriks, Jenny, Weverling, Gerrit Jan, Goudsmit, Jaap, Sizemore, Donata, McClain, Bruce J., Goetz, Margaret, Gearhart, Jacqueline, Mahomed, Hassan, Hussey, Gregory D., Sadoff, Jerald C., and Hanekom, Willem A.

Published
2010
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16. Live-attenuated Mycobacterium tuberculosis vaccine MTBVAC versus BCG in adults and neonates: a randomised controlled, double-blind dose-escalation trial

Author

Tameris, Michele, primary, Mearns, Helen, additional, Penn-Nicholson, Adam, additional, Gregg, Yolande, additional, Bilek, Nicole, additional, Mabwe, Simbarashe, additional, Geldenhuys, Hennie, additional, Shenje, Justin, additional, Luabeya, Angelique Kany Kany, additional, Murillo, Ingrid, additional, Doce, Juana, additional, Aguilo, Nacho, additional, Marinova, Dessislava, additional, Puentes, Eugenia, additional, Rodríguez, Esteban, additional, Gonzalo-Asensio, Jesús, additional, Fritzell, Bernard, additional, Thole, Jelle, additional, Martin, Carlos, additional, Scriba, Thomas J, additional, Hatherill, Mark, additional, Africa, Hadn, additional, Arendsen, Denis, additional, Botes, Natasja, additional, Cloete, Yolundi, additional, De Kock, Marwou, additional, Erasmus, Margaret, additional, Jack, Lungisa, additional, Kafaar, Fazlin, additional, Kalepu, Xoliswa, additional, Khomba, Nondumiso Gloria, additional, Kruger, Sandra, additional, Leopeng, Thelma, additional, Makhethe, Lebohang, additional, Mouton, Angelique, additional, Mulenga, Humphrey, additional, Musvosvi, Munyaradzi, additional, Noble, Julia, additional, Opperman, Fajwa, additional, Reid, Tim, additional, Rossouw, Susan, additional, Schreuder, Constance, additional, Smit, Erica, additional, Steyn, Marcia, additional, Tyambethu, Petrus, additional, Van Rooyen, Elma, additional, and Veldsman, Ashley, additional

Published
2019
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17. Dose Optimization of H56:IC31 Vaccine for Tuberculosis-Endemic Populations. A Double-Blind, Placebo-controlled, Dose-Selection Trial

Author

Suliman, Sara, primary, Luabeya, Angelique Kany Kany, additional, Geldenhuys, Hennie, additional, Tameris, Michele, additional, Hoff, Soren T., additional, Shi, Zhongkai, additional, Tait, Dereck, additional, Kromann, Ingrid, additional, Ruhwald, Morten, additional, Rutkowski, Kathryn Tucker, additional, Shepherd, Barbara, additional, Hokey, David, additional, Ginsberg, Ann M., additional, Hanekom, Willem A., additional, Andersen, Peter, additional, Scriba, Thomas J., additional, Hatherill, Mark, additional, Oelofse, Rachel Elizabeth, additional, Stone, Lynnett, additional, Swarts, Anne Marie, additional, Onrust, Raida, additional, Jacobs, Gail, additional, Coetzee, Lorraine, additional, Khomba, Gloria, additional, Diamond, Bongani, additional, Companie, Alessandro, additional, Veldsman, Ashley, additional, Mulenga, Humphrey, additional, Cloete, Yolundi, additional, Steyn, Marcia, additional, Africa, Hadn, additional, Nkantsu, Lungisa, additional, Smit, Erica, additional, Botes, Janelle, additional, Bilek, Nicole, additional, and Mabwe, Simbarashe, additional

Published
2019
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18. Toll-like receptor chaperone HSP90B1 and the immune response to Mycobacteria

Author

Graustein, Andrew D., primary, Misch, Elizabeth A., additional, Musvosvi, Munyaradzi, additional, Shey, Muki, additional, Shah, Javeed A., additional, Seshadri, Chetan, additional, Aguoju, Augustine, additional, Bowman, Kathryn, additional, Mulenga, Humphrey, additional, Veldsman, Ashley, additional, Hanekom, Willem A., additional, Hatherill, Mark, additional, Scriba, Thomas J., additional, and Hawn, Thomas R., additional

Published
2018
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19. Optimization and Interpretation of Serial QuantiFERON Testing to Measure Acquisition of Mycobacterium tuberculosis Infection

Author

Nemes, Elisa, primary, Rozot, Virginie, additional, Geldenhuys, Hennie, additional, Bilek, Nicole, additional, Mabwe, Simbarashe, additional, Abrahams, Deborah, additional, Makhethe, Lebohang, additional, Erasmus, Mzwandile, additional, Keyser, Alana, additional, Toefy, Asma, additional, Cloete, Yolundi, additional, Ratangee, Frances, additional, Blauenfeldt, Thomas, additional, Ruhwald, Morten, additional, Walzl, Gerhard, additional, Smith, Bronwyn, additional, Loxton, Andre G., additional, Hanekom, Willem A., additional, Andrews, Jason R., additional, Lempicki, Maria D., additional, Ellis, Ruth, additional, Ginsberg, Ann M., additional, Hatherill, Mark, additional, Scriba, Thomas J., additional, Rossouw, Susan, additional, Jones, Carolyn, additional, Schoeman, Elisma, additional, Gregg, Yolande, additional, Beyers, Elizabeth, additional, Kruger, Sandra, additional, Veltdsman, Helen, additional, Keffers, Sophie, additional, Goliath, Sandra, additional, Mullins, Mariana, additional, Tameris, Michele, additional, Luabeya, Angelique, additional, Veldsman, Ashley, additional, Mulenga, Humphrey, additional, Hendricks, Angelique, additional, Opperman, Fajwa, additional, Van Rooyen, Elma, additional, Noble, Julia, additional, Braaf, Samentra, additional, Ockhuis, Rose, additional, Vermeulen, Emerencia, additional, Companie, Alessandro, additional, Kelepu, Xoliswa, additional, Ratangee, Maigan, additional, Pretorius, Abraham, additional, Issel, Henry, additional, Langata, Phumzile, additional, Davids, Ilse, additional, Herling, Roxanne, additional, Africa, Hadn, additional, Steyn, Marcia, additional, Nkantso, Lungisa, additional, Xoyana, Noncedo, additional, Diamond, Bongani, additional, Erasmus, Margareth, additional, Hughes, Jane, additional, van der Westhuizen, Denise, additional, Makunzi, Lydia, additional, Botes, Natasja, additional, Amsterdam, Julia, additional, Maqubela, Clive, additional, Dlakavu, Portia, additional, Mangala, Pamela, additional, Abrahams, Charmaine, additional, Tyambetyu, Petrus, additional, Gempies, Diann, additional, Elbring, Cindy, additional, Hamilton, Elizabeth, additional, Alexander, Fadia, additional, Matiwane, Sindile Wiseman, additional, September, Cashwin, additional, Petersen, Christel, additional, Herselman, Yulande, additional, Hector, Johanna, additional, Esterhuizen, Terence, additional, Mactavie, Lauren, additional, van der Riet, Elize, additional, Pretorius, Debbie, additional, Shenje, Justin, additional, Swarts, Anne, additional, Sinandile, Eunice, additional, Botes, Janelle, additional, Schreuder, Constance, additional, Kassiem, Jateel, additional, Xasa, Onke, additional, Mosito, Boitumelo, additional, Raphela, Rodney, additional, Arendsen, Denis, additional, Dolo, Palesa, additional, Filander, Elizabeth, additional, Mahomed, Hassan, additional, Kafaar, Fazlin, additional, Workman, Leslie, additional, Ehrlich, Rodney, additional, Moyo, Sizulu, additional, Gelderbloem, Sebastian, additional, and Hussey, Gregory, additional

Published
2017
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20. Live-attenuated Mycobacterium tuberculosisvaccine MTBVAC versus BCG in adults and neonates: a randomised controlled, double-blind dose-escalation trial

Author

Tameris, Michele, Mearns, Helen, Penn-Nicholson, Adam, Gregg, Yolande, Bilek, Nicole, Mabwe, Simbarashe, Geldenhuys, Hennie, Shenje, Justin, Luabeya, Angelique Kany Kany, Murillo, Ingrid, Doce, Juana, Aguilo, Nacho, Marinova, Dessislava, Puentes, Eugenia, Rodríguez, Esteban, Gonzalo-Asensio, Jesús, Fritzell, Bernard, Thole, Jelle, Martin, Carlos, Scriba, Thomas J, Hatherill, Mark, Africa, Hadn, Arendsen, Denis, Botes, Natasja, Cloete, Yolundi, De Kock, Marwou, Erasmus, Margaret, Jack, Lungisa, Kafaar, Fazlin, Kalepu, Xoliswa, Khomba, Nondumiso Gloria, Kruger, Sandra, Leopeng, Thelma, Makhethe, Lebohang, Mouton, Angelique, Mulenga, Humphrey, Musvosvi, Munyaradzi, Noble, Julia, Opperman, Fajwa, Reid, Tim, Rossouw, Susan, Schreuder, Constance, Smit, Erica, Steyn, Marcia, Tyambethu, Petrus, Van Rooyen, Elma, and Veldsman, Ashley

Abstract

Infants are a key target population for new tuberculosis vaccines. We assessed the safety and immunogenicity of the live-attenuated Mycobacterium tuberculosisvaccine candidate MTBVAC in adults and infants in a region where transmission of tuberculosis is very high.

Published
2019
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21. The novel tuberculosis vaccine, AERAS-402, is safe in healthy infants previously vaccinated with BCG, and induces dose-dependent CD4 and CD8T cell responses

Author

Kagina, Benjamin M.N., primary, Tameris, Michele D., additional, Geldenhuys, Hennie, additional, Hatherill, Mark, additional, Abel, Brian, additional, Hussey, Gregory D., additional, Scriba, Thomas J., additional, Mahomed, Hassan, additional, Sadoff, Jerald C., additional, Hanekom, Willem A., additional, Mansoor, Nazma, additional, Hughes, Jane, additional, de Kock, Marwou, additional, Whatney, Wendy, additional, Africa, Hadn, additional, Krohn, Colleen, additional, Veldsman, Ashley, additional, Kany, Angelique Luabeya Kany, additional, Douoguih, Macaya, additional, Pau, Maria Grazia, additional, Hendriks, Jenny, additional, McClain, Bruce, additional, Benko, Jacqueline, additional, Snowden, Margaret A., additional, and Hokey, David A., additional

Published
2014
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22. Human newborn bacille Calmette-Guérin vaccination and risk of tuberculosis disease: a case-control study.

Author

Fletcher, Helen A., Filali-Mouhim, Ali, Nemes, Elisa, Hawkridge, Anthony, Keyser, Alana, Njikan, Samuel, Hatherill, Mark, Scriba, Thomas J., Abel, Brian, Kagina, Benjamin M., Veldsman, Ashley, Marín Agudelo, Nancy, Kaplan, Gilla, Hussey, Gregory D., Sekaly, Rafick-Pierre, Hanekom, Willem A., Agudelo, Nancy Marín, and BCG study team

Subjects
TUBERCULOSIS, VACCINES, MYCOBACTERIUM bovis, GENE expression, SYSTEMS biology, TUBERCULOSIS prevention, BCG vaccines, IMMUNOMODULATORS, COMPARATIVE studies, GENES, IMMUNIZATION, LONGITUDINAL method, RESEARCH methodology, MEDICAL cooperation, RESEARCH, EVALUATION research, CASE-control method
Abstract

Background: An incomplete understanding of the immunological mechanisms underlying protection against tuberculosis (TB) hampers the development of new vaccines against TB. We aimed to define host correlates of prospective risk of TB disease following bacille Calmette-Guérin (BCG) vaccination.Methods: In this study, 5,726 infants vaccinated with BCG at birth were enrolled. Host responses in blood collected at 10 weeks of age were compared between infants who developed pulmonary TB disease during 2 years of follow-up (cases) and those who remained healthy (controls).Results: Comprehensive gene expression and cellular and soluble marker analysis failed to identify a correlate of risk. We showed that distinct host responses after BCG vaccination may be the reason: two major clusters of gene expression, with different myeloid and lymphoid activation and inflammatory patterns, were evident when all infants were examined together. Cases from each cluster demonstrated distinct patterns of gene expression, which were confirmed by cellular assays.Conclusions: Distinct patterns of host responses to Mycobacterium bovis BCG suggest that novel TB vaccines may also elicit distinct patterns of host responses. This diversity should be considered in future TB vaccine development. [ABSTRACT FROM AUTHOR]

Published
2016
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23. Correction: Modified vaccinia Ankara‐expressing Ag85A, a novel tuberculosis vaccine, is safe in adolescents and children, and induces polyfunctional CD4+ T cells

Author

Scriba, Thomas J., primary, Tameris, Michele, additional, Mansoor, Nazma, additional, Smit, Erica, additional, van der Merwe, Linda, additional, Isaacs, Fatima, additional, Keyser, Alana, additional, Moyo, Sizulu, additional, Brittain, Nathaniel, additional, Lawrie, Alison, additional, Gelderbloem, Sebastian, additional, Veldsman, Ashley, additional, Hatherill, Mark, additional, Hawkridge, Anthony, additional, Hill, Adrian V. S., additional, Hussey, Gregory D., additional, Mahomed, Hassan, additional, McShane, Helen, additional, and Hanekom, Willem A., additional

Published
2011
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24. Modified vaccinia Ankara-expressing Ag85A, a novel tuberculosis vaccine, is safe in adolescents and children, and induces polyfunctional CD4+ T cells

Author

Scriba, Thomas J., primary, Tameris, Michele, additional, Mansoor, Nazma, additional, Smit, Erica, additional, van der Merwe, Linda, additional, Isaacs, Fatima, additional, Keyser, Alana, additional, Moyo, Sizulu, additional, Brittain, Nathaniel, additional, Lawrie, Alison, additional, Gelderbloem, Sebastian, additional, Veldsman, Ashley, additional, Hatherill, Mark, additional, Hawkridge, Anthony, additional, Hill, Adrian V. S., additional, Hussey, Gregory D., additional, Mahomed, Hassan, additional, McShane, Helen, additional, and Hanekom, Willem A., additional

Published
2009
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25. Modified vaccinia Ankara-expressing Ag85A, a novel tuberculosis vaccine, is safe in adolescents and children, and induces polyfunctional CD4.

Author

Scriba, Thomas J., Tameris, Michele, Mansoor, Nazma, Smit, Erica, van der Merwe, Linda, Isaacs, Fatima, Keyser, Alana, Moyo, Sizulu, Brittain, Nathaniel, Lawrie, Alison, Gelderbloem, Sebastian, Veldsman, Ashley, Hatherill, Mark, Hawkridge, Anthony, Hill, Adrian V. S., Hussey, Gregory D., Mahomed, Hassan, McShane, Helen, and Hanekom, Willem A.

Abstract

Modified vaccinia Ankara-expressing Ag85A (MVA85A) is a new tuberculosis (TB) vaccine aimed at enhancing immunity induced by BCG. We investigated the safety and immunogenicity of MVA85A in healthy adolescents and children from a TB endemic region, who received BCG at birth. Twelve adolescents and 24 children were vaccinated and followed up for 12 or 6 months, respectively. Adverse events were documented and vaccine-induced immune responses assessed by IFN-γ ELISpot and intracellular cytokine staining. The vaccine was well tolerated and there were no vaccine-related serious adverse events. MVA85A induced potent and durable T-cell responses. Multiple CD4 [ABSTRACT FROM AUTHOR]

Published
2010
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26. Additional file 1: Figure S1. of Human newborn bacille Calmetteâ GuĂŠrin vaccination and risk of tuberculosis disease: a case-control study

Author

Fletcher, Helen, Filali-Mouhim, Ali, Nemes, Elisa, Hawkridge, Anthony, Keyser, Alana, Njikan, Samuel, Hatherill, Mark, Scriba, Thomas, Abel, Brian, Kagina, Benjamin, Veldsman, Ashley, Agudelo, Nancy, Kaplan, Gilla, Hussey, Gregory, Rafick-Pierre Sekaly, and Hanekom, Willem

Subjects
3. Good health
Abstract

Stability of the two major gene expression clusters. Figure S2. Gene expression in cases and controls. Figure S3. BCG-specific induction of soluble cytokine/chemokine production in cases and controls. Figure S4. Frequencies of proliferating BCG-specific T cells in cases and controls. Figure S5. Frequencies of specific T cells expressing cytotoxic molecules in cases and controls. Figure S6. Frequencies of myeloid and lymphoid cellular subsets in cryopreserved PBMC in cases and controls. Figure S7. Gene expression in the validation cohort of probable TB cases and community controls. Figure S8. Clustering of gene expression in unstimulated samples. Figure S9. In vitro modulation of gene expression by BCG. Figure S10. Frequencies of antigen-specific CD4 and CD8 T cells expressing cytotoxic molecules, and of proliferating BCG-specific T cells, in cases of each cluster, and in controls. (PDF 2443 kb)

27. Additional file 1: Figure S1. of Human newborn bacille Calmetteâ GuĂŠrin vaccination and risk of tuberculosis disease: a case-control study

Author

Fletcher, Helen, Filali-Mouhim, Ali, Nemes, Elisa, Hawkridge, Anthony, Keyser, Alana, Njikan, Samuel, Hatherill, Mark, Scriba, Thomas, Abel, Brian, Kagina, Benjamin, Veldsman, Ashley, Agudelo, Nancy, Kaplan, Gilla, Hussey, Gregory, Rafick-Pierre Sekaly, and Hanekom, Willem

Subjects
3. Good health
Abstract

Stability of the two major gene expression clusters. Figure S2. Gene expression in cases and controls. Figure S3. BCG-specific induction of soluble cytokine/chemokine production in cases and controls. Figure S4. Frequencies of proliferating BCG-specific T cells in cases and controls. Figure S5. Frequencies of specific T cells expressing cytotoxic molecules in cases and controls. Figure S6. Frequencies of myeloid and lymphoid cellular subsets in cryopreserved PBMC in cases and controls. Figure S7. Gene expression in the validation cohort of probable TB cases and community controls. Figure S8. Clustering of gene expression in unstimulated samples. Figure S9. In vitro modulation of gene expression by BCG. Figure S10. Frequencies of antigen-specific CD4 and CD8 T cells expressing cytotoxic molecules, and of proliferating BCG-specific T cells, in cases of each cluster, and in controls. (PDF 2443 kb)

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