Search Results - "Mngadi, Kathryn"

Recombinant adenovirus type 5 HIV gag/pol/nef vaccine in South Africa: unblinded, long-term follow-up of the phase 2b HVTN 503/Phambili study by Gray, Glenda E, Prof, Moodie, Zoe, PhD, Metch, Barbara, MS, Gilbert, Peter B, PhD, Bekker, Linda-Gail, Prof, Churchyard, Gavin, PhD, Nchabeleng, Maphoshane, MBChB, Mlisana, Koleka, MBChB, Laher, Fatima, MBBCH, Roux, Surita, MBChB, Mngadi, Kathryn, MPhil, Innes, Craig, MBChB, Mathebula, Matsontso, MBChB, Allen, Mary, MS, McElrath, M Julie, Prof, Robertson, Michael, MD, Kublin, James, MD, Corey, Lawrence, Prof

“…Summary Background The HVTN 503/Phambili study, which assessed the efficacy of the Merck Ad5 gag/pol/nef subtype B HIV-1 preventive vaccine in South Africa,…”
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Undue inducement: a case study in CAPRISA 008 by Mngadi, Kathryn T, Singh, Jerome A, Mansoor, Leila E, Wassenaar, Douglas R

“…Participant safety and data integrity, critical in trials of new investigational drugs, are achieved through honest participant report and precision in the…”
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Continued Follow-Up of Phambili Phase 2b Randomized HIV-1 Vaccine Trial Participants Supports Increased HIV-1 Acquisition among Vaccinated Men by Moodie, Zoe, Metch, Barbara, Bekker, Linda-Gail, Churchyard, Gavin, Nchabeleng, Maphoshane, Mlisana, Koleka, Laher, Fatima, Roux, Surita, Mngadi, Kathryn, Innes, Craig, Mathebula, Matsontso, Allen, Mary, Bentley, Carter, Gilbert, Peter B, Robertson, Michael, Kublin, James, Corey, Lawrence, Gray, Glenda E

“…The Phase 2b double-blinded, randomized Phambili/HVTN 503 trial evaluated safety and efficacy of the MRK Ad5 gag/pol/nef subtype B HIV-1 preventive vaccine vs…”
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Integrated provision of topical pre‐exposure prophylaxis in routine family planning services in South Africa: a non‐inferiority randomized controlled trial by Mansoor, Leila E, Yende‐Zuma, Nonhlanhla, Baxter, Cheryl, Mngadi, Kathryn T, Dawood, Halima, Gengiah, Tanuja N, Samsunder, Natasha, Schwartz, Jill L, Doncel, Gustavo F, Abdool Karim, Quarraisha

“…Introduction Tenofovir‐containing oral pre‐exposure prophylaxis (PrEP) is recommended for those at substantial risk as part of combination HIV prevention…”
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Pharmacokinetics and predicted neutralisation coverage of VRC01 in HIV-uninfected participants of the Antibody Mediated Prevention (AMP) trials by Huang, Yunda, Naidoo, Logashvari, Zhang, Lily, Carpp, Lindsay N., Rudnicki, Erika, Randhawa, April, Gonzales, Pedro, McDermott, Adrian, Ledgerwood, Julie, Lorenzo, Margarita M.Gomez, Burns, David, DeCamp, Allan, Juraska, Michal, Mascola, John, Edupuganti, Srilatha, Mgodi, Nyaradzo, Cohen, Myron, Corey, Lawrence, Andrew, Philip, Karuna, Shelly, Gilbert, Peter B., Mngadi, Kathryn, Lazarus, Erica

“…The phase 2b AMP trials are testing whether the broadly neutralising antibody VRC01 prevents HIV-1 infection in two cohorts: women in sub-Saharan Africa, and…”
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Adverse events with isoniazid preventive therapy: experience from a large trial by Grant, Alison D, Mngadi, Kathryn T, van Halsema, Clare L, Luttig, Mariëtha M, Fielding, Katherine L, Churchyard, Gavin J

“…We describe isoniazid-related adverse events in Thibela TB, a cluster-randomized study of community-wide isoniazid preventive therapy (IPT) among gold miners…”
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Assessing the implementation effectiveness and safety of 1% tenofovir gel provision through family planning services in KwaZulu-Natal, South Africa: study protocol for an open-label randomized controlled trial by Mansoor, Leila E, Abdool Karim, Quarraisha, Mngadi, Kathryn T, Dlamini, Sarah, Montague, Carl, Nkomonde, Nelisiwe, Mvandaba, Nomzamo, Baxter, Cheryl, Gengiah, Tanuja N, Samsunder, Natasha, Dawood, Halima, Grobler, Anneke, Frohlich, Janet A, Abdool Karim, Salim S

“…The Centre for the AIDS Programme of Research in South Africa (CAPRISA) 004 trial demonstrated a 39% reduction in HIV infection, with a 54% HIV reduction in…”
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'Team up against TB': promoting involvement in Thibela TB, a trial of community-wide tuberculosis preventive therapy by Grant, Alison D, Coetzee, Leonie, Fielding, Katherine L, Lewis, James J, Ntshele, Smanga, Luttig, Mariëtha M, Mngadi, Kathryn T, Muller, Dorothy, Popane, Flora, Mdluli, John, Mngadi, Nkosinathi, Sefuthi, Clement, Clark, David A, Churchyard, Gavin

“…To describe a programme of community education and mobilization to promote uptake in a cluster-randomized trial of tuberculosis preventive therapy offered to…”
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Respiratory Syncytial Virus Prefusion F Protein Vaccine Is Efficacious in Older Adults With Underlying Medical Conditions by Feldman, Robert G, Antonelli-Incalzi, Raffaele, Steenackers, Katie, Lee, Dong-Gun, Papi, Alberto, Ison, Michael G, Fissette, Laurence, David, Marie-Pierre, Maréchal, Céline, Van der Wielen, Marie, Kostanyan, Lusine, Hulstrøm, Veronica

“…Older adults with chronic cardiorespiratory or endocrine/metabolic conditions are at increased risk of respiratory syncytial virus (RSV)-related acute…”
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Efficacy and Safety of Respiratory Syncytial Virus (RSV) Prefusion F Protein Vaccine (RSVPreF3 OA) in Older Adults Over 2 RSV Seasons by Ison, Michael G, Papi, Alberto, Athan, Eugene, Feldman, Robert G, Langley, Joanne M, Lee, Dong-Gun, Leroux-Roels, Isabel, Martinon-Torres, Federico, Schwarz, Tino F, van Zyl-Smit, Richard N, Verheust, Céline, Dezutter, Nancy, Gruselle, Olivier, Fissette, Laurence, David, Marie-Pierre, Kostanyan, Lusine, Hulstrøm, Veronica, Olivier, Aurélie, Van der Wielen, Marie, Descamps, Dominique

“…Abstract Background The adjuvanted RSV prefusion F protein–based vaccine (RSVPreF3 OA) was efficacious against RSV-related lower respiratory tract disease…”
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Using Mobile Technology (pMOTAR) to Assess Reactogenicity: Protocol for a Pilot Randomized Controlled Trial by Mngadi, Kathryn Therese, Maharaj, Bhavna, Duki, Yajna, Grove, Douglas, Andriesen, Jessica

“…Accurate safety monitoring in HIV vaccine trials is vital to eventual licensure and consequent uptake of products. Current practice in preventive vaccine…”
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Safety and immunogenicity of a subtype C ALVAC-HIV by Moodie, Zoe, Andersen-Nissen, Erica, Grunenberg, Nicole, Dintwe, One B, Omar, Faatima Laher, Kee, Jia J, Bekker, Linda-Gail, Laher, Fatima, Naicker, Nivashnee, Jani, Ilesh, Mgodi, Nyaradzo M, Hunidzarira, Portia, Sebe, Modulakgota, Miner, Maurine D, Polakowski, Laura, Ramirez, Shelly, Nebergall, Michelle, Takuva, Simbarashe, Sikhosana, Lerato, Heptinstall, Jack, Seaton, Kelly E, De Rosa, Stephen, Diazgranados, Carlos A, Koutsoukos, Marguerite, Van Der Meeren, Olivier, Barnett, Susan W, Kanesa-thasan, Niranjan, Kublin, James G, Tomaras, Georgia D, McElrath, M. Juliana, Corey, Lawrence, Mngadi, Kathryn, Goepfert, Paul

“…Background Adjuvants are widely used to enhance and/or direct vaccine-induced immune responses yet rarely evaluated head-to-head. Our trial directly compared…”
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Safety and immunogenicity of a subtype C ALVAC-HIV : A phase 1/2a randomized trial by Moodie, Zoe, Andersen-Nissen, Erica, Grunenberg, Nicole, Dintwe, One B, Omar, Faatima Laher, Kee, Jia J, Bekker, Linda-Gail, Laher, Fatima, Naicker, Nivashnee, Jani, Ilesh, Mgodi, Nyaradzo M, Hunidzarira, Portia, Sebe, Modulakgota, Miner, Maurine D, Polakowski, Laura, Ramirez, Shelly, Nebergall, Michelle, Takuva, Simbarashe, Sikhosana, Lerato, Heptinstall, Jack, Seaton, Kelly E, De Rosa, Stephen, Diazgranados, Carlos A, Koutsoukos, Marguerite, Van Der Meeren, Olivier, Barnett, Susan W, Kanesa-thasan, Niranjan, Kublin, James G, Tomaras, Georgia D, McElrath, M. Juliana, Corey, Lawrence, Mngadi, Kathryn, Goepfert, Paul

“…Background Adjuvants are widely used to enhance and/or direct vaccine-induced immune responses yet rarely evaluated head-to-head. Our trial directly compared…”
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Mosaic HIV-1 vaccine regimen in southern African women (Imbokodo/HVTN 705/HPX2008): a randomised, double-blind, placebo-controlled, phase 2b trial by Gray, Glenda E, Mngadi, Kathryn, Lavreys, Ludo, Nijs, Steven, Gilbert, Peter B, Hural, John, Hyrien, Ollivier, Juraska, Michal, Luedtke, Alex, Mann, Philipp, McElrath, M Juliana, Odhiambo, Jackline A, Stieh, Daniel J, van Duijn, Janine, Takalani, Azwidihwi N, Willems, Wouter, Tapley, Asa, Tomaras, Georgia D, Van Hoof, Johan, Schuitemaker, Hanneke, Swann, Edith, Barouch, Dan H, Kublin, James G, Corey, Lawrence, Pau, Maria G, Buchbinder, Susan, Tomaka, Frank, Allagappen, Jon, Andriesen, Jessica, Ayres, Alison, Bekker, Linda-Gail, Borremans, Caroline, Brumskine, William, Chilengi, Roma, Dubula, Thozama, Garrett, Nigel, Gelderblom, Huub, Gill, Katherine, Hoosain, Zaheer, Hosseinipour, Mina, Hutter, Julia, Inambao, Mubiana, Innes, Craig, Kilembe, William, Kotze, Philippus, Kotze, Sheena, Laher, Fatima, Laszlo, Imre, Lazarus, Erica, Malahleha, Mookho, Mathebula, Matsontso, Matoga, Mitch, McClennen, Rachael, Mda, Pamela, Meerts, Peter, Naicker, Vimla, Naidoo, Logashvari, Philip, Tricia, Pitsi, Annah, Scheppler, Lorenz, Sopher, Carrie, Takuva, Simbarashe G., Viegas, Edna, Weijtens, Mo, Yuan, Olive

“…HIV type 1 (HIV-1) remains a global health concern, with the greatest burden in sub-Saharan Africa. Despite 40 years of research, no vaccine candidate has…”
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Safety and immunogenicity of a subtype C ALVAC-HIV (vCP2438) vaccine prime plus bivalent subtype C gp120 vaccine boost adjuvanted with MF59 or alum in healthy adults without HIV (HVTN 107): A phase 1/2a randomized trial by Moodie, Zoe, Andersen-Nissen, Erica, Grunenberg, Nicole, Dintwe, One B, Omar, Faatima Laher, Kee, Jia J, Bekker, Linda-Gail, Laher, Fatima, Naicker, Nivashnee, Jani, Ilesh, Mgodi, Nyaradzo M, Hunidzarira, Portia, Sebe, Modulakgota, Miner, Maurine D, Polakowski, Laura, Ramirez, Shelly, Nebergall, Michelle, Takuva, Simbarashe, Sikhosana, Lerato, Heptinstall, Jack, Seaton, Kelly E, De Rosa, Stephen, Diazgranados, Carlos A, Koutsoukos, Marguerite, Van Der Meeren, Olivier, Barnett, Susan W, Kanesa-Thasan, Niranjan, Kublin, James G, Tomaras, Georgia D, McElrath, M Juliana, Corey, Lawrence, Mngadi, Kathryn, Goepfert, Paul

“…Adjuvants are widely used to enhance and/or direct vaccine-induced immune responses yet rarely evaluated head-to-head. Our trial directly compared immune…”
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Safety and immune responses after a 12-month booster in healthy HIV-uninfected adults in HVTN 100 in South Africa: A randomized double-blind placebo-controlled trial of ALVAC-HIV (vCP2438) and bivalent subtype C gp120/MF59 vaccines by Laher, Fatima, Moodie, Zoe, Cohen, Kristen W, Grunenberg, Nicole, Bekker, Linda-Gail, Allen, Mary, Frahm, Nicole, Yates, Nicole L, Morris, Lynn, Malahleha, Mookho, Mngadi, Kathryn, Daniels, Brodie, Innes, Craig, Saunders, Kevin, Grant, Shannon, Yu, Chenchen, Gilbert, Peter B, Phogat, Sanjay, DiazGranados, Carlos A, Koutsoukos, Marguerite, Van Der Meeren, Olivier, Bentley, Carter, Mkhize, Nonhlanhla N, Pensiero, Michael N, Mehra, Vijay L, Kublin, James G, Corey, Lawrence, Montefiori, David C, Gray, Glenda E, McElrath, M Juliana, Tomaras, Georgia D

“…HVTN 100 evaluated the safety and immunogenicity of an HIV subtype C pox-protein vaccine regimen, investigating a 12-month booster to extend vaccine-induced…”
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Disclosure of Microbicide Gel Use to Sexual Partners: Influence on Adherence in the CAPRISA 004 Trial by Mngadi, Kathryn Therese, Maarschalk, Silvia, Grobler, Anneke C., Mansoor, Leila E., Frohlich, Janet A., Madlala, Bernadette, Ngcobo, Nelisiwe, Abdool Karim, Salim S., Abdool Karim, Quarraisha

“…Young women in sub-Saharan Africa are disproportionately affected by HIV, making the development of women initiated and controlled methods of prevention,…”
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Immune correlates analysis of the Imbokodo (HVTN 705/HPX2008) efficacy trial of a mosaic HIV-1 vaccine regimen evaluated in Southern African people assigned female sex at birth: a two-phase case-control studyResearch in context by Avi Kenny, Janine van Duijn, One Dintwe, Jack Heptinstall, Randy Burnham, Sheetal Sawant, Lu Zhang, Dieter Mielke, Sharon Khuzwayo, Faatima Laher Omar, Sherry Stanfield-Oakley, Taylor Keyes, Brooke Dunn, Derrick Goodman, Youyi Fong, David Benkeser, Rodger Zou, John Hural, Ollivier Hyrien, Michal Juraska, Alex Luedtke, Lars van der Laan, Elena E. Giorgi, Craig Magaret, Lindsay N. Carpp, Laura Pattacini, Tom van de Kerkhof, Bette Korber, Wouter Willems, Leigh H. Fisher, Hanneke Schuitemaker, Edith Swann, James G. Kublin, Maria G. Pau, Susan Buchbinder, Frank Tomaka, Steven Nijs, Ludo Lavreys, Huub C. Gelderblom, Lawrence Corey, Kathryn Mngadi, Glenda E. Gray, Erica Borducchi, Jenny Hendriks, Kelly E. Seaton, Susan Zolla-Pazner, Dan H. Barouch, Guido Ferrari, Stephen C. De Rosa, M Juliana McElrath, Erica Andersen-Nissen, Daniel J. Stieh, Georgia D. Tomaras, Peter B. Gilbert, Jon Allagappen, Jessica Andriesen, Alison Ayres, Saman Baral, Linda-Gail Bekker, Asiphe Besethi, Caroline Borremans, Esmee Braams, Caroline Brackett, William Brumskine, Roma Chilengi, Rachel Choi, Thozama Dubula, Jaiden Seongmi Dumas, Brooke Dunn, Radhika Etikala, Zelda Euler, Sarah Everett, Nigel Garrett, Huub Gelderblom, Katherine Gill, Kevin Gillespie, Dimitri Goedhart, Erik Goosmann, Shannon Grant, Ellie Hands, Barton Haynes, Bronwill Herringer, Zaheer Hoosain, Mina Hosseinipour, Portia Hunidzarira, Julia Hutter, Mubiana Inambao, Craig Innes, Taylor Keyes, William Kilembe, Philippus Kotze, Sheena Kotze, Fatima Laher, Imre Laszlo, Erica Lazarus, Hua-Xin Liao, Yong Lin, Helen Lu, Judith Lucas, Mookho Malahleha

“…Background: The HVTN 705 Imbokodo trial of 2636 people without HIV and assigned female sex at birth, conducted in southern Africa, evaluated a heterologous…”
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Safety and immunogenicity after a 30-month boost of a subtype C ALVAC-HIV (vCP2438) vaccine prime plus bivalent subtype C gp120/MF59 vaccine boost (HVTN 100): A phase 1-2 randomized double-blind placebo-controlled trial by Naicker, Vimla, Laher, Fatima, Bekker, Linda-Gail, Seaton, Kelly E, Allen, Mary, De Rosa, Stephen, Yates, Nicole L, Mkhize, Nonhlanhla N, Saunders, Kevin, Heptinstall, Jack, Malahleha, Mookho, Mngadi, Kathryn, Daniels, Brodie, Innes, Craig, Yu, Chenchen, Modise, Tandile, Bekker, Valerie, Grunenberg, Nicole, Furch, Briana, Miner, Maurine D, Phogat, Sanjay, Diazgranados, Carlos A, Gurunathan, Sanjay, Koutsoukos, Marguerite, Van Der Meeren, Olivier, Roxby, Alison C, Ferrari, Guido, Morris, Lynn, Montefiori, David, McElrath, M Juliana, Tomaras, Georgia D, Moodie, Zoe

“…Induction of broad, durable immune responses is a challenge in HIV vaccine development. HVTN 100 Part A administered subtype C-containing ALVAC-HIV at months 0…”
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Challenges with participant reimbursement: experiences from a post-trial access study by Mngadi, Kathryn Therese, Frohlich, Janet, Montague, Carl, Singh, Jerome, Nkomonde, Nelisiwe, Mvandaba, Nomzamo, Ntombeka, Fanelesibonge, Luthuli, Londiwe, Abdool Karim, Quarraisha, Mansoor, Leila

“…Reimbursement of trial participants remains a frequently debated issue, with specific guidance lacking. Trials combining post-trial access and implementation…”
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