Pharmacokinetics and predicted neutralisation coverage of VRC01 in HIV-uninfected participants of the Antibody Mediated Prevention (AMP) trials

Autor: John R. Mascola, Lily Zhang, Logashvari Naidoo, Erica Lazarus, David P. Burns, Myron S. Cohen, Michal Juraska, Yunda Huang, Lindsay N. Carpp, Kathryn Therese. Mngadi, Pedro Gonzales, April K. Randhawa, Julie E. Ledgerwood, Margarita M. Gomez Lorenzo, Allan C. deCamp, Nyaradzo Mgodi, Erika Rudnicki, Srilatha Edupuganti, Adrian B. McDermott, Shelly Karuna, Peter B. Gilbert, Philip Andrew, Lawrence Corey

Publikováno v: EBioMedicine, Vol 64, Iss, Pp 103203-(2021)
EBioMedicine

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 men and transgender persons who have sex with men (MSM/TG) in the Americas and Switzerland.

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::66dc14768a759aec4f021f7fd44d67d7
http://www.sciencedirect.com/science/article/pii/S235239642030579X

A Phase 2b Study to Evaluate the Safety and Efficacy of VRC01 Broadly Neutralizing Monoclonal Antibody in Reducing Acquisition of HIV-1 Infection in Women in Sub-Saharan Africa: Baseline Findings

Autor: Hvtn, Nidhi Kochar, John R. Mascola, Lawrence Corey, Elizabeth Greene, Maurine D. Miner, Nyaradzo Mgodi, India Tindale, Hptn (PopART) Study Team, Philip Andrew, Erica Lazarus, Kyle E. Marshall, Nandisile Luthuli, David N. Burns, Margarita M. Gomez Lorenzo, Emily Shava, Precious Garnett, Michal Juraska, Erika Rudnicki, Carissa Karg, Pamela G Mukwekwerere, Shelly Karuna, Maija Anderson, Srilatha Edupuganti, Simbarashe G. Takuva, Kagisho Baepanye, Myron S. Cohen, Deborah Donnell, John Hural, Julie E. Ledgerwood

Publikováno v: J Acquir Immune Defic Syndr

Background HIV Vaccine Trials Network 703/HIV Prevention Trials Network 081 is a phase 2b randomized, double-blind, placebo-controlled trial to assess the safety and efficacy of passively infused monoclonal antibody VRC01 in preventing HIV acquisitio

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::fb7b10e41e4b15be0aca8236eeae681d
https://pubmed.ncbi.nlm.nih.gov/33587510

Effect of Bamlanivimab vs Placebo on Incidence of COVID-19 Among Residents and Staff of Skilled Nursing and Assisted Living Facilities

Autor: Myron S, Cohen, Ajay, Nirula, Mark J, Mulligan, Richard M, Novak, Mary, Marovich, Catherine, Yen, Alexander, Stemer, Stockton M, Mayer, David, Wohl, Blair, Brengle, Brian T, Montague, Ian, Frank, Russell J, McCulloh, Carl J, Fichtenbaum, Brad, Lipson, Nashwa, Gabra, Julio A, Ramirez, Christine, Thai, Wairimu, Chege, Margarita M, Gomez Lorenzo, Nirupama, Sista, Jennifer, Farrior, Meredith E, Clement, Elizabeth R, Brown, Kenneth L, Custer, Jacob, Van Naarden, Andrew C, Adams, Andrew E, Schade, Matan C, Dabora, Jack, Knorr, Karen L, Price, Janelle, Sabo, Jay L, Tuttle, Paul, Klekotka, Lei, Shen, Daniel M, Skovronsky, George, Taffet

Publikováno v: JAMA. 326:46

IMPORTANCE Preventive interventions are needed to protect residents and staff of skilled nursing and assisted living facilities from COVID-19 during outbreaks in their facilities. Bamlanivimab, a neutralizing monoclonal antibody against SARS-CoV-2, m

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::0258235561f5370f7c10ea27186c4bbf
https://doi.org/10.1001/jama.2021.8828

1272. Feasibility and Successful Enrollment in Proof-of-Concept Trials to Assess Safety and Efficacy of a Broadly Neutralizing Monoclonal Antibody, VRC01, to Prevent HIV-1 Acquisitionin in Uninfected Individuals

Autor: John R. Mascola, Margarita M. Gomez Lorenzo, Simbarashe Takuva, J. McElrath, Martin Casapia, Nidhi Kochar, Jorge Sanchez, Shelly Karuna, Erica Lazarus, Paul A. Goepfert, Lawrence Corey, Maija Anderson, Philip Andrew, John Hural, Myron S. Cohen, Emily Shava, David N. Burns, Kyle E. Marshall, Allan C. deCamp, Robert De La Grecca, Nyaradzo Mgodi, Srilatha Edupuganti, Pamela G Mukwekwerere

Publikováno v: Open Forum Infectious Diseases

Background The Antibody-mediated Prevention (AMP) trials (HVTN 704/HPTN 085 and HVTN 703/HPTN 081) are the first efficacy trials to evaluate whether VRC01, a broadly neutralizing antibody (bnAb) that targets CD4 binding site of HIV envelope, prevents

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::198176729ef98d58b109b7a0bb5b381d
https://doi.org/10.1093/ofid/ofz360.1135

Thromboembolic events after Ad.26.COV2.S COVID-19 vaccine: Reports to the Vaccine Adverse Event Reporting System.

Autor: Woo EJ; Office of Biostatistics and Pharmacovigilance, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA., Mba-Jonas A; Office of Biostatistics and Pharmacovigilance, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA., Thomas A; Office of Biostatistics and Pharmacovigilance, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA., Baer B; Office of Biostatistics and Pharmacovigilance, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA., Day B; Office of Biostatistics and Pharmacovigilance, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA., Kim Y; Office of Biostatistics and Pharmacovigilance, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA., Gomez-Lorenzo M; Office of Biostatistics and Pharmacovigilance, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA., Nair N; Office of Biostatistics and Pharmacovigilance, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.

Publikováno v: Pharmacoepidemiology and drug safety [Pharmacoepidemiol Drug Saf] 2022 Nov; Vol. 31 (11), pp. 1174-1181. Date of Electronic Publication: 2022 Sep 05.