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1. 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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2. 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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3. A Quantitative Analysis of Complexity of Human Pathogen-Specific CD4 T Cell Responses in Healthy M. tuberculosis Infected South Africans.

Author

Lindestam Arlehamn, Cecilia S, McKinney, Denise M, Carpenter, Chelsea, Paul, Sinu, Rozot, Virginie, Makgotlho, Edward, Gregg, Yolande, van Rooyen, Michele, Ernst, Joel D, Hatherill, Mark, Hanekom, Willem A, Peters, Bjoern, Scriba, Thomas J, and Sette, Alessandro

Subjects
CD4-Positive T-Lymphocytes, Humans, Mycobacterium tuberculosis, Tuberculosis, Antigens, Bacterial, HLA Antigens, Epitopes, T-Lymphocyte, Fluorescent Antibody Technique, Adult, South Africa, Female, Male, Enzyme-Linked Immunospot Assay, Antigens, Bacterial, Epitopes, T-Lymphocyte, Virology, Microbiology, Immunology, Medical Microbiology
Abstract

We performed a quantitative analysis of the HLA restriction, antigen and epitope specificity of human pathogen specific responses in healthy individuals infected with M. tuberculosis (Mtb), in a South African cohort as a test case. The results estimate the breadth of T cell responses for the first time in the context of an infection and human population setting. We determined the epitope repertoire of eleven representative Mtb antigens and a large panel of previously defined Mtb epitopes. We estimated that our analytic methods detected 50-75% of the total response in a cohort of 63 individuals. As expected, responses were highly heterogeneous, with responses to a total of 125 epitopes detected. The 66 top epitopes provided 80% coverage of the responses identified in our study. Using a panel of 48 HLA class II-transfected antigen-presenting cells, we determined HLA class II restrictions for 278 epitope/donor recognition events (36% of the total). The majority of epitopes were restricted by multiple HLA alleles, and 380 different epitope/HLA combinations comprised less than 30% of the estimated Mtb-specific response. Our results underline the complexity of human T cell responses at a population level. Efforts to capture and characterize this broad and highly HLA promiscuous Mtb-specific T cell epitope repertoire will require significant peptide multiplexing efforts. We show that a comprehensive "megapool" of Mtb peptides captured a large fraction of the Mtb-specific T cells and can be used to characterize this response.

Published
2016

4. A Quantitative Analysis of Complexity of Human Pathogen-Specific CD4 T Cell Responses in Healthy M. tuberculosis Infected South Africans

Author

Arlehamn, Cecilia S Lindestam, McKinney, Denise M, Carpenter, Chelsea, Paul, Sinu, Rozot, Virginie, Makgotlho, Edward, Gregg, Yolande, van Rooyen, Michele, Ernst, Joel D, Hatherill, Mark, Hanekom, Willem A, Peters, Bjoern, Scriba, Thomas J, and Sette, Alessandro

Subjects
Vaccine Related, Clinical Research, Biodefense, Infectious Diseases, Tuberculosis, Rare Diseases, Emerging Infectious Diseases, Prevention, HIV/AIDS, Aetiology, 2.1 Biological and endogenous factors, Infection, Good Health and Well Being, Adult, Antigens, Bacterial, CD4-Positive T-Lymphocytes, Enzyme-Linked Immunospot Assay, Epitopes, T-Lymphocyte, Female, Fluorescent Antibody Technique, HLA Antigens, Humans, Male, Mycobacterium tuberculosis, South Africa, Microbiology, Immunology, Medical Microbiology, Virology
Abstract

We performed a quantitative analysis of the HLA restriction, antigen and epitope specificity of human pathogen specific responses in healthy individuals infected with M. tuberculosis (Mtb), in a South African cohort as a test case. The results estimate the breadth of T cell responses for the first time in the context of an infection and human population setting. We determined the epitope repertoire of eleven representative Mtb antigens and a large panel of previously defined Mtb epitopes. We estimated that our analytic methods detected 50-75% of the total response in a cohort of 63 individuals. As expected, responses were highly heterogeneous, with responses to a total of 125 epitopes detected. The 66 top epitopes provided 80% coverage of the responses identified in our study. Using a panel of 48 HLA class II-transfected antigen-presenting cells, we determined HLA class II restrictions for 278 epitope/donor recognition events (36% of the total). The majority of epitopes were restricted by multiple HLA alleles, and 380 different epitope/HLA combinations comprised less than 30% of the estimated Mtb-specific response. Our results underline the complexity of human T cell responses at a population level. Efforts to capture and characterize this broad and highly HLA promiscuous Mtb-specific T cell epitope repertoire will require significant peptide multiplexing efforts. We show that a comprehensive "megapool" of Mtb peptides captured a large fraction of the Mtb-specific T cells and can be used to characterize this response.

Published
2016

5. 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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6. 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

7. 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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8. 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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9. Statistical Analysis Plan

Author

Tameris, Michele, Mearns, Helen, Penn-Nicholson, Adam, Gregg, Yolande, Bilek, Nicole, Simbarashe Mabwe, Geldenhuys, Hennie, Shenje, Justine, Luabeya, Angelique, Murillo, Ingrid, Doce, Juana, Aguilo, Nacho, Marinova, Dessislava, Rodriguez, Esteban, Pentes, Eugenia, Gonzalo-Asensio, Jesús, Fritzell, Bernard, Thole, Jelle, Martin, Carlos, Scriba, Thomas, Hatherill, Mark, and MTBVAC Clinical Trial Team

Subjects
FOS: Clinical medicine, Immunology
Abstract

Statistical analysis plan for the MTBVAC 201 clinical trial. A phase Ib, randomised, double-blind, dose-escalation clinical trial of the safety, reactogenicity and immunogenicity of MTBVAC compared to BCG Vaccine SSI, in newborns living in a tuberculosis endemic region with a safety arm in adults.

Published
2019
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10. Cllinical Trial Protocol

Author

Tameris, Michele, Mearns, Helen, Penn-Nicholson, Adam, Gregg, Yolande, Bilek, Nicole, Simbarashe Mabwe, Geldenhuys, Hennie, Shenje, Justine, Luabeya, Angelique, Murillo, Ingrid, Doce, Juana, Aguilo, Nacho, Marinova, Dessislava, Puentes, Eugenia, Rodríguez, Esteban, Gonzalo-Asensio, Jesús, Fritzell, Bernard, Thole, Jelle, Martin, Carlos, Scriba, Thomas, Hatherill, Mark, and MTBVAC Clinical Trial Team

Subjects
FOS: Clinical medicine, Immunology
Abstract

Clinical trial protocol for MTBVAC 201 trial.

Published
2019
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11. Analysis Plan

Author

Tameris, Michele, Mearns, Helen, Penn-Nicholson, Adam, Gregg, Yolande, Bilek, Nicole, Simbarashe Mabwe, Geldenhuys, Hennie, Shenje, Justine, Luabeya, Angelique, Murillo, Ingrid, Doce, Juana, Aguilo, Nacho, Marinova, Dessislava, Puentes, Eugenia, Rodríguez, Esteban, Gonzalo-Asensio, Jesús, Fritzell, Bernard, Thole, Jelle, Martin, Carlos, Scriba, Thomas, Hatherill, Mark, and MTBVAC Clinical Trial Team

Subjects
FOS: Clinical medicine, Immunology
Abstract

Analysis plan for the primary endpoint of MTBVAC 201

Published
2019
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12. 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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13. 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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14. 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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