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2. Effects of BCG vaccination on donor unrestricted T cells in two prospective cohort studies

Author

Gela, Anele, Murphy, Melissa, Rodo, Miguel, Hadley, Kate, Hanekom, Willem A., Boom, W.Henry, Johnson, John L., Hoft, Daniel F., Joosten, Simone A., Ottenhoff, Tom H.M., Suliman, Sara, Moody, D.Branch, Lewinsohn, David M., Hatherill, Mark, Seshadri, Chetan, Nemes, Elisa, Scriba, Thomas J., Briel, Libby, Veldtsman, Hellen, Khomba, Nondumiso, Pienaar, Bernadette, Africa, Hadn, and Steyn, Marcia

Published
2022
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4. 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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5. 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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6. 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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7. 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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8. H1:IC31 vaccination is safe and induces long-lived TNF-α+IL-2+CD4 T cell responses in M. tuberculosis infected and uninfected adolescents: A randomized trial

Author

Rozot, Virginie, Abrahams, Deborah A., Mauff, Katya, Smit, Erica, Brown, Yolande, Hughes, E. Jane, Makgotlho, Edward, Keyser, Alana, Erasmus, Mzwandile, Makhethe, Lebohang, Africa, Hadn, Hopley, Charles, Steyn, Marcia, Mearns, Helen, Geldenhuys, Hennie D., Kagina, Benjamin M., Musvosvi, Munyaradzi, Little, Francesca, Ratangee, Frances, Mahomed, Hassan, Hanekom, Willem A., Hoff, Søren T., Ruhwald, Morten, Kromann, Ingrid, Bang, Peter, Hatherill, Mark, Andersen, Peter, and Scriba, Thomas J.

Published
2017
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9. First-in-human trial of the post-exposure tuberculosis vaccine H56:IC31 in Mycobacterium tuberculosis infected and non-infected healthy adults

Author

Luabeya, Angelique Kany Kany, Kagina, Benjamin M.N., Tameris, Michele D., Geldenhuys, Hennie, Hoff, Soren T., Shi, Zhongkai, Kromann, Ingrid, Hatherill, Mark, Mahomed, Hassan, Hanekom, Willem A., Andersen, Peter, Scriba, Thomas J., Schoeman, Elisma, Krohn, Colleen, Day, Cheryl L., Africa, Hadn, Makhethe, Lebohang, Smit, Erica, Brown, Yolande, Suliman, Sara, Hughes, E. Jane, Bang, Peter, Snowden, Margaret A., McClain, Bruce, and Hussey, Gregory D.

Published
2015
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10. Newborn BCG vaccination induces robust infant IFNγ-expressing NK cell responses to mycobacteria

Author

Murphy, Melissa, primary, Suliman, Sara, additional, Briel, Libby, additional, Veldtsman, Helen, additional, Khomba, Nondumiso, additional, Africa, Hadn, additional, Steyn, Marcia, additional, Snyders, Candice I., additional, van Rensburg, Ilana C., additional, Walzl, Gerhard, additional, Chegou, Novel N., additional, Hatherill, Mark, additional, Hanekom, Willem A., additional, Scriba, Thomas J., additional, and Nemes, Elisa, additional

Published
2023
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11. 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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12. Tuberculosis alters immune-metabolic pathways resulting in perturbed IL-1 responses

Author

Llibre, Alba, primary, Smith, Nikaïa, additional, Rouilly, Vincent, additional, Musvosvi, Munyaradzi, additional, Nemes, Elisa, additional, Posseme, Céline, additional, Mabwe, Simbarashe, additional, Charbit, Bruno, additional, Mbandi, Stanley Kimbung, additional, Filander, Elizabeth, additional, Africa, Hadn, additional, Saint-André, Violaine, additional, Bondet, Vincent, additional, Bost, Pierre, additional, Mulenga, Humphrey, additional, Bilek, Nicole, additional, Albert, Matthew L., additional, Scriba, Thomas J., additional, and Duffy, Darragh, additional

Published
2022
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13. Immune profiling enables stratification of patients with active TB disease or M. tuberculosis infection

Author

Duffy, Darragh, Nemes, Elisa, Llibre, Alba, Rouilly, Vincent, Musvosvi, Munyaradzi, Smith, Nikaïa, Filander, Elizabeth, Africa, Hadn, Mabwe, Simbarashe, Jaxa, Lungisa, Charbit, Bruno, Mulenga, Humphrey, Milieu Intérieur, Consortium, Tameris, Michele, Walzl, Gerhard, Malherbe, Stephanus, Thomas, Stephanie, Hatherill, Mark, Bilek, Nicole, Scriba, Thomas, Albert, Matthew, Immunobiologie des Cellules dendritiques, Institut Pasteur [Paris] (IP)-Institut National de la Santé et de la Recherche Médicale (INSERM), University of Cape Town, Datactix, Centre de Recherche Translationnelle - Center for Translational Science (CRT), Institut Pasteur [Paris] (IP), Stellenbosch University, Insitro [San Francisco], We acknowledge the Bill and Melinda Gates Foundation (OPP1114368) for funding the study and additional support from the French Government’s Investissement d’Avenir Program, Laboratoire d’Excellence ' Milieu Intérieur' Grant ANR-10-LABX-69-01. For clinical collection of TB patient samples included in the replication cohort we acknowledge support from the Bill and Melinda Gates Foundation (OPP1155128), the European and Developing Countries Clinical Trials Partnership (96425), and the Intramural Research Program of the NIAID, NIH, and the National Institutes of Health (1U01AI115619-01). EN is an International Society for Advancement of Cytometry (ISAC) Marylou Ingram Scholar and AL was supported by the Fondation Recherche Médicale (SPF20170938617)., We acknowledge the UTechS CB and Icareb platforms of the Center for Translational Research, Institut Pasteur. We are grateful to the study participants and the SATVI clinical and laboratory teams., The Milieu Intérieur Consortium is composed of the following team leaders: Laurent Abel (Hôpital Necker), Andres Alcover, Hugues Aschard, Kalla Astrom (Lund University), Philippe Bousso, Pierre Bruhns, Ana Cumano, Caroline Demangel, Ludovic Deriano, James Di Santo, Françoise Dromer, Gérard Eberl, Jost Enninga, Jacques Fellay (EPFL, Lausanne) Odile Gelpi, Ivo Gomperts-Boneca, Milena Hasan, Serge Hercberg (Université Paris 13), Olivier Lantz (Institut Curie), Claude Leclerc, Hugo Mouquet, Etienne Patin, Sandra Pellegrini, Stanislas Pol (Hôpital Côchin), Antonio Rausell (INSERM UMR 1163 –Institut Imagine), Lars Rogge, Anavaj Sakuntabhai, Olivier Schwartz, Benno Schwikowski, Spencer Shorte, Vassili Soumelis (Institut Curie), Frédéric Tangy, Eric Tartour (Hôpital Européen George Pompidou), Antoine Toubert (Hôpital Saint-Louis), Mathilde Touvier (Université Paris 13), Marie-Noëlle Ungeheuer, Matthew L. Albert (Insitro), Darragh Duffy, Lluis Quintana-Murci, ANR-10-LABX-0069,MILIEU INTERIEUR,GENETIC & ENVIRONMENTAL CONTROL OF IMMUNE PHENOTYPE VARIANCE: ESTABLISHING A PATH TOWARDS PERSONALIZED MEDICINE(2010), Institut Pasteur [Paris]-Institut National de la Santé et de la Recherche Médicale (INSERM), and Institut Pasteur [Paris]

Subjects
Patient stratification, Tuberculosis, biomarkers, [SDV.IMM]Life Sciences [q-bio]/Immunology, bacterial infections and mycoses, Immune profiling, cytokines
Abstract

International audience; BackgroundTuberculosis (TB) is caused by Mycobacterium tuberculosis (Mtb) infection and is a major public health problem. Clinical challenges include the lack of a blood-based test for active disease. Current blood-based tests, such as QuantiFERON (QFT) do not distinguish active TB disease from asymptomatic Mtb infection.MethodsWe hypothesized that TruCulture, an immunomonitoring method for whole blood stimulation, could discriminate active disease from latent Mtb infection (LTBI). We stimulated whole blood from active TB patients and compared to LTBI donors. Mtb- specific antigens and live bacillus Calmette-Guerin (BCG) were used as stimuli, with direct comparison to QFT. Protein analyses were performed using conventional and digital ELISA, as well as Luminex.ResultsTruCulture showed discrimination of active TB cases from LTBI (p < 0.0001 AUC = 0.81) as compared to QFT (p = 0.45 AUC = 0.56), based on an IFNγ readout after Mtb antigen stimulation. This result was replicated in an independent cohort (AUC = 0.89). In exploratory analyses, TB stratification could be further improved by the Mtb Ag/BCG IFNγ ratio (p < 0.0001 AUC = 0.91). Finally, the combination of digital ELISA and transcriptional analysis showed that LTBI donors with high IFNγ clustered with TB patients, suggesting the possibility to identify sub-clinical disease.ConclusionsTruCulture offers a next-generation solution for whole blood stimulation and immunomonitoring with the possibility to discriminate active and latent infection.

Published
2020
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14. 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

15. 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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16. 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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17. 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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18. Inflammatory Determinants of Differential Tuberculosis Risk in Pre-Adolescent Children and Young Adults

Author

Baguma, Richard, primary, Mbandi, Stanley Kimbung, additional, Rodo, Miguel J., additional, Erasmus, Mzwandile, additional, Day, Jonathan, additional, Makhethe, Lebohang, additional, de Kock, Marwou, additional, van Rooyen, Michele, additional, Stone, Lynnett, additional, Bilek, Nicole, additional, Steyn, Marcia, additional, Africa, Hadn, additional, Darboe, Fatoumatta, additional, Chegou, Novel N., additional, Tromp, Gerard, additional, Walzl, Gerhard, additional, Hatherill, Mark, additional, Penn-Nicholson, Adam, additional, and Scriba, Thomas J., additional

Published
2021
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19. Newborn BCG Vaccination Induces Robust Infant IFN

Author

Murphy, Melissa, primary, Suliman, Sara, additional, Briel, Libby, additional, Veldtsman, Helen, additional, Khomba, Nondumiso, additional, Africa, Hadn, additional, Steyn, Marcia, additional, Snyders, Candice I., additional, van Rensburg, Ilana C., additional, Walzl, Gerhard, additional, Chegou, Novel N., additional, Hatherill, Mark, additional, Hanekom, Willem, additional, Scriba, Thomas J., additional, and Nemes, Elisa, additional

Published
2021
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20. Tuberculosis alters immune-metabolic pathways resulting in perturbed IL-1 responses

Author

Llibre, Alba, primary, Smith, Nikaïa, additional, Rouilly, Vincent, additional, Musvosvi, Munyaradzi, additional, Nemes, Elisa, additional, Posseme, Céline, additional, Mabwe, Simba, additional, Charbit, Bruno, additional, Mbandi, Stanley Kimbung, additional, Filander, Elizabeth, additional, Africa, Hadn, additional, Saint-André, Violaine, additional, Bondet, Vincent, additional, Bost, Pierre, additional, Mulenga, Humphrey, additional, Bilek, Nicole, additional, Albert, Matthew L, additional, Scriba, Thomas J, additional, and Duffy, Darragh, additional

Published
2020
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21. Longitudinal Dynamics of a Blood Transcriptomic Signature of Tuberculosis.

Author

Mulenga, Humphrey, Musvosvi, Munyaradzi, Mendelsohn, Simon C., Penn-Nicholson, Adam, Mbandi, Stanley Kimbung, Fiore-Gartland, Andrew, Tameris, Michele, Mabwe, Simbarashe, Africa, Hadn, Bilek, Nicole, Kafaar, Fazlin, Khader, Shabaana A., Carstens, Balie, Hadley, Katie, Hikuam, Chris, Erasmus, Mzwandile, Jaxa, Lungisa, Raphela, Rodney, Nombida, Onke, and Kaskar, Masooda

Subjects
TUBERCULOSIS, BIOMARKERS, RESPIRATORY infections, HIV, MESSENGER RNA
Abstract

Rationale: Performance of blood transcriptomic tuberculosis (TB) signatures in longitudinal studies and effects of TB-preventive therapy and coinfection with HIV or respiratory organisms on transcriptomic signatures has not been systematically studied. Objectives: We evaluated longitudinal kinetics of an 11-gene blood transcriptomic TB signature, RISK11, and effects of TB-preventive therapy (TPT) and respiratory organisms on RISK11 signature score, in HIV-uninfected and HIV-infected individuals. Methods: RISK11 was measured in a longitudinal study of RISK11-guided TPT in HIV-uninfected adults, a cross-sectional respiratory organisms cohort, or a longitudinal study in people living with HIV (PLHIV). HIV-uninfected RISK11+ participants were randomized to TPT or no TPT; RISK11- participants received no TPT. PLHIV received standard-of-care antiretroviral therapy and TPT. In the cross-sectional respiratory organisms cohort, viruses and bacteria in nasopharyngeal and oropharyngeal swabs were quantified by real-time quantitative PCR. Measurements and Main Results: RISK11+ status was transient in most of the 128 HIV-negative participants with longitudinal samples; more than 70% of RISK11+ participants reverted to RISK11- by 3 months, irrespective of TPT. By comparison, reversion from a RISK11+ state was less common in 645 PLHIV (42.1%). Non-HIV viral and nontuberculous bacterial organisms were detected in 7.2% and 38.9% of the 1,000 respiratory organisms cohort participants, respectively, and among those investigated for TB, 3.8% had prevalent disease. Median RISK11 scores (%) were higher in participants with viral organisms alone (46.7%), viral and bacterial organisms (42.8%), or prevalent TB (85.7%) than those with bacterial organisms other than TB (13.4%) or no organisms (14.2%). RISK11 could not discriminate between prevalent TB and viral organisms. Conclusions: Positive RISK11 signature status is often transient, possibly due to intercurrent viral infection, highlighting potentially important challenges for implementation of these biomarkers as new tools for TB control. [ABSTRACT FROM AUTHOR]

Published
2021
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22. Immune Profiling Enables Stratification of Patients With Active Tuberculosis Disease or Mycobacterium tuberculosis Infection.

Author

Duffy, Darragh, Nemes, Elisa, Llibre, Alba, Rouilly, Vincent, Musvosvi, Munyaradzi, Smith, Nikaïa, Filander, Elizabeth, Africa, Hadn, Mabwe, Simbarashe, Jaxa, Lungisa, Charbit, Bruno, Mulenga, Humphrey, Tameris, Michele, Walzl, Gerhard, Malherbe, Stephanus, Thomas, Stephanie, Hatherill, Mark, Bilek, Nicole, Scriba, Thomas J, and Albert, Matthew L

Subjects
MYCOBACTERIAL disease diagnosis, ANTIGEN analysis, BLOOD testing, PROTEIN analysis, TUBERCULOSIS diagnosis, INTERFERON gamma release tests, CYTOKINES, BIOMARKERS, PREDICTIVE tests, BACILLUS (Bacteria), IMMUNOPHENOTYPING, ENZYME-linked immunosorbent assay
Abstract

Background Tuberculosis (TB) is caused by Mycobacterium tuberculosis (Mtb) infection and is a major public health problem. Clinical challenges include the lack of a blood-based test for active disease. Current blood-based tests, such as QuantiFERON (QFT) do not distinguish active TB disease from asymptomatic Mtb infection. Methods We hypothesized that TruCulture, an immunomonitoring method for whole-blood stimulation, could discriminate active disease from latent Mtb infection (LTBI). We stimulated whole blood from patients with active TB and compared with LTBI donors. Mtb -specific antigens and live bacillus Calmette-Guérin (BCG) were used as stimuli, with direct comparison to QFT. Protein analyses were performed using conventional and digital enzyme-linked immunosorbent assay (ELISA), as well as Luminex. Results TruCulture showed discrimination of active TB cases from LTBI (P <.0001, AUC =.81) compared with QFT (P =.45, AUC =.56), based on an interferon γ (IFNγ) readout after Mtb antigen (Ag) stimulation. This result was replicated in an independent cohort (AUC =.89). In exploratory analyses, TB stratification could be further improved by the Mtb antigen to BCG IFNγ ratio (P <.0001, AUC =.91). Finally, the combination of digital ELISA and transcriptional analysis showed that LTBI donors with high IFNγ clustered with patients with TB, suggesting the possibility to identify subclinical disease. Conclusions TruCulture offers a next-generation solution for whole-blood stimulation and immunomonitoring with the possibility to discriminate active and latent infection. [ABSTRACT FROM AUTHOR]

Published
2021
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23. Noninvasive Detection of Tuberculosis by Oral Swab Analysis

Author

Luabeya, Angelique K., Wood, Rachel C., Shenje, Justin, Filander, Elizabeth, Ontong, Cynthia, Mabwe, Simbarashe, Africa, Hadn, Nguyen, Felicia K., Olson, Alaina, Weigel, Kris M., Jones-Engel, Lisa, Hatherill, Mark, and Cangelosi, Gerard A.

Subjects
Adult, Diagnostic Tests, Routine, GeneXpert MTB/RIF, Sputum, food and beverages, oral swab, Mycobacteriology and Aerobic Actinomycetes, Mycobacterium tuberculosis, Sensitivity and Specificity, point of care, respiratory tract diseases, fluids and secretions, PCR, tuberculosis, molecular diagnosis, Humans, Tuberculosis, Pulmonary, nonsputum sampling, POC
Abstract

Diagnostic tests for tuberculosis (TB) usually require collection of sputum, a viscous material derived from human airways. Sputum can be difficult and hazardous to collect and challenging to process in the laboratory., Diagnostic tests for tuberculosis (TB) usually require collection of sputum, a viscous material derived from human airways. Sputum can be difficult and hazardous to collect and challenging to process in the laboratory. Oral swabs have been proposed as alternative sample types that are noninvasive and easy to collect. This study evaluated the biological feasibility of oral swab analysis (OSA) for the diagnosis of TB. Swabs were tested from South African adult subjects, including sputum GeneXpert MTB/RIF (GeneXpert)-confirmed TB patients (n = 138), sputum GeneXpert-negative but culture-positive TB patients (n = 10), ill non-TB patients (n = 37), and QuantiFERON-negative controls (n = 34). Swabs were analyzed by using a manual, nonnested quantitative PCR (qPCR) targeting IS6110. Two swab brands and three sites within the oral cavity were compared. Tongue swabbing yielded significantly stronger signals than cheek or gum swabbing. A flocked swab performed better than a more expensive paper swab. In a two-phase study, tongue swabs (two per subject) exhibited a combined sensitivity of 92.8% relative to sputum GeneXpert. Relative to all laboratory-diagnosed TB, the diagnostic yields of sputum GeneXpert (1 sample per subject) and OSA (2 samples per subject) were identical at 49/59 (83.1%) each. The specificity of the OSA was 91.5%. An analysis of “air swabs” suggested that most false-positive results were due to contamination of manual PCRs. With the development of appropriate automated methods, oral swabs could facilitate TB diagnosis in clinical settings and patient populations that are limited by the physical or logistical challenges of sputum collection.

Published
2019

24. Diagnostic performance of an optimized transcriptomic signature of risk of tuberculosis in cryopreserved peripheral blood mononuclear cells

Author

Matiwane, Sindile, Jaxa, Lungisa, Xoyana, Noncedo, Schreuder, Constance, Botes, Janelle, Africa, Hadn, Makhethe, Lebohang, Steyn, Marcia, Darboe, Fatoumatta, Mbandi, Stanley Kimbung, Thompson, Ethan G., Fisher, Michelle, Rodo, Miguel, van Rooyen, Michele, Filander, Elizabeth, Bilek, Nicole, Mabwe, Simbarashe, Hatherill, Mark, Zak, Daniel E., Penn-Nicholson, Adam, and Scriba, Thomas J.

Published
2018
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25. 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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26. 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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27. T-cell biomarkers for diagnosis of tuberculosis: candidate evaluation by a simple whole blood assay for clinical translation

Author

Musvosvi, Munyaradzi, primary, Duffy, Darragh, additional, Filander, Elizabeth, additional, Africa, Hadn, additional, Mabwe, Simbarashe, additional, Jaxa, Lungisa, additional, Bilek, Nicole, additional, Llibre, Alba, additional, Rouilly, Vincent, additional, Hatherill, Mark, additional, Albert, Matthew, additional, Scriba, Thomas J., additional, and Nemes, Elisa, additional

Published
2018
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28. Diagnostic performance of an optimized transcriptomic signature of risk of tuberculosis in cryopreserved peripheral blood mononuclear cells

Author

Darboe, Fatoumatta, primary, Mbandi, Stanley Kimbung, additional, Thompson, Ethan G., additional, Fisher, Michelle, additional, Rodo, Miguel, additional, van Rooyen, Michele, additional, Filander, Elizabeth, additional, Bilek, Nicole, additional, Mabwe, Simbarashe, additional, Hatherill, Mark, additional, Zak, Daniel E., additional, Penn-Nicholson, Adam, additional, Scriba, Thomas J., additional, Matiwane, Sindile, additional, Jaxa, Lungisa, additional, Xoyana, Noncedo, additional, Schreuder, Constance, additional, Botes, Janelle, additional, Africa, Hadn, additional, Makhethe, Lebohang, additional, and Steyn, Marcia, additional

Published
2018
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29. 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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30. H1:IC31 vaccination is safe and induces long-lived TNF-α+IL-2+CD4 T cell responses in M. tuberculosis infected and uninfected adolescents: A randomized trial

Author

Mearns, Helen, primary, Geldenhuys, Hennie D., additional, Kagina, Benjamin M., additional, Musvosvi, Munyaradzi, additional, Little, Francesca, additional, Ratangee, Frances, additional, Mahomed, Hassan, additional, Hanekom, Willem A., additional, Hoff, Søren T., additional, Ruhwald, Morten, additional, Kromann, Ingrid, additional, Bang, Peter, additional, Hatherill, Mark, additional, Andersen, Peter, additional, Scriba, Thomas J., additional, Rozot, Virginie, additional, Abrahams, Deborah A., additional, Mauff, Katya, additional, Smit, Erica, additional, Brown, Yolande, additional, Hughes, E. Jane, additional, Makgotlho, Edward, additional, Keyser, Alana, additional, Erasmus, Mzwandile, additional, Makhethe, Lebohang, additional, Africa, Hadn, additional, Hopley, Charles, additional, and Steyn, Marcia, additional

Published
2017
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31. 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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33. 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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34. Maturation of Innate Responses to Mycobacteria over the First Nine Months of Life

Author

Shey, Muki S., primary, Nemes, Elisa, additional, Whatney, Wendy, additional, de Kock, Marwou, additional, Africa, Hadn, additional, Barnard, Charlene, additional, van Rooyen, Michele, additional, Stone, Lynnett, additional, Riou, Catherine, additional, Kollmann, Tobias, additional, Hawn, Thomas R., additional, Scriba, Thomas J., additional, and Hanekom, Willem A., additional

Published
2014
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35. Differential leukocyte counting and immunophenotyping in cryopreserved ex vivo whole blood.

Author

Nemes, Elisa, Kagina, Benjamin M. N., Smit, Erica, Africa, Hadn, Steyn, Marcia, Hanekom, Willem A., and Scriba, Thomas J.

Abstract

Absolute cell counts are typically measured in fresh samples, but this is impractical in large field studies. We compared quantification of leukocyte proportions and absolute counts using reference real-time methods (stain and lyse/no-wash (LNW) or hematology analyser) with a novel assay that allows long-term cryopreservation of fixed leukocytes for later counting (DLC-ICE: differential leukocyte count and immunophenotype in cryopreserved ex vivo whole blood). For the LNW method, whole blood (WB) was stained with fluorescent antibodies, then erythrocytes were lysed, and leukocytes fixed prior to flow cytometry. Alternatively, our novel DLC-ICE method entailed erythrocyte lysis and leukocyte fixation, cryopreservation and later staining of permeabilized cells prior to flow cytometry. Outcomes were proportions and absolute counts of granulocytes, lymphocytes, monocytes, T cells, B cells, and activated T cells within the leukocyte population. We also compared leukocyte subset counts in fresh WB from 51 healthy infants measured by hematology analyser at a rural clinical site or by DLC-ICE method after 2 years of cryopreservation. We observed excellent agreement and strong correlations between absolute counts or cell proportions measured by the LNW and DLC-ICE methods on fresh WB from 10 healthy adults. Compared to LNW, DLC-ICE yielded similar or brighter staining even after cryopreservation. Duration of cryopreservation, assessed monthly for 1 year, had little effect on cell enumeration: median coefficients of variation were below 15% for all outcomes. Under field site conditions, we observed strong correlations between infant leukocyte numbers measured in fresh samples by hematology analyser and those measured by DLC-ICE up to 2 years of cryopreservation. Our novel DLC-ICE method allows accurate flow cytometric quantification of cell subsets from fixed WB even after long-term cryopreservation. This method is ideal for batched, retrospective analysis of samples from large field studies, or when advanced flow cytometry equipment is not available for clinical research purposes. © 2014 International Society for Advancement of Cytometry [ABSTRACT FROM AUTHOR]

Published
2015
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36. Noninvasive Detection of Tuberculosis by Oral Swab Analysis

Author

Luabeya, Angelique K., Wood, Rachel C., Shenje, Justin, Filander, Elizabeth, Ontong, Cynthia, Mabwe, Simbarashe, Africa, Hadn, Nguyen, Felicia K., Olson, Alaina, Weigel, Kris M., Jones-Engel, Lisa, Hatherill, Mark, and Cangelosi, Gerard A.

Abstract

Diagnostic tests for tuberculosis (TB) usually require collection of sputum, a viscous material derived from human airways. Sputum can be difficult and hazardous to collect and challenging to process in the laboratory.

Published
2018
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