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Two Randomized Trials of Neutralizing Antibodies to Prevent HIV-1 Acquisition

by Baden, Lindsey R , Sista, Nirupama , Gomez Lorenzo, Margarita M , Morris, Lynn , Mascola, John R , Juraska, Michal , Karuna, Shelly T , Sobieszczyk, Magdalena E , Edupuganti, Srilatha , Sanchez, Jorge , Hinojosa, Juan , Donnell, Deborah J , Kochar, Nidhi , Makhema, Joseph , Huang, Yunda , Rudnicki, Erika , Takuva, Simbarashe , Lama, Javier R , Burns, David N , Corey, Lawrence , deCamp, Allan C , Orrell, Catherine , Lazarus, Erica M , Gilbert, Peter B , Gonzales, Pedro , Hural, John , Piwowar-Manning, Estelle , Espy, Nicole , Marshall, Kyle E , Randhawa, April K , Andrew, Philip , Gray, Glenda , Frank, Ian , Williamson, Carolyn , Cohen, Myron S , Ledgerwood, Julie E , Mgodi, Nyaradzo M , Laher, Fatima , Kublin, James G , Cabello, Robinson , Mullins, James I , Montefiori, David C , Mukwekwerere, Pamela G , McElrath, M. Juliana , Bentley, Carter

in Adolescent / Adult / Adverse events / Africa South of the Sahara - epidemiology / Allergies / Americas - epidemiology / Antibodies / Antibodies, Monoclonal - adverse effects / Antibodies, Monoclonal - therapeutic use / Binding sites / Broadly Neutralizing Antibodies - adverse effects / Broadly Neutralizing Antibodies - therapeutic use / Collaboration / Confidence intervals / Design / Double-Blind Method / Enrollments / Europe - epidemiology / Female / HIV / HIV Antibodies - adverse effects / HIV Antibodies - therapeutic use / HIV Infections - epidemiology / HIV Infections - prevention & control / HIV-1 - drug effects / Human immunodeficiency virus / Humans / Incidence / Infections / Infectious diseases / Male / Medical research / Medical tests / Placebos / Prevention / Proof of Concept Study / Prophylaxis / Protocol / Statistical analysis / Transgender persons / Young Adult

2021

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Two Randomized Trials of Neutralizing Antibodies to Prevent HIV-1 Acquisition

2021

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Two Randomized Trials of Neutralizing Antibodies to Prevent HIV-1 Acquisition

2021

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Journal Article

Two Randomized Trials of Neutralizing Antibodies to Prevent HIV-1 Acquisition

Baden, Lindsey R,

Sista, Nirupama,

Gomez Lorenzo, Margarita M,

Morris, Lynn,

Mascola, John R,

Juraska, Michal,

Karuna, Shelly T,

Sobieszczyk, Magdalena E,

Edupuganti, Srilatha,

Sanchez, Jorge,

Hinojosa, Juan,

Donnell, Deborah J,

Kochar, Nidhi,

Makhema, Joseph,

Huang, Yunda,

Rudnicki, Erika,

Takuva, Simbarashe,

Lama, Javier R,

Burns, David N,

Corey, Lawrence,

deCamp, Allan C,

Orrell, Catherine,

Lazarus, Erica M,

Gilbert, Peter B,

Gonzales, Pedro,

Hural, John,

Piwowar-Manning, Estelle,

Espy, Nicole,

Marshall, Kyle E,

Randhawa, April K,

Andrew, Philip,

Gray, Glenda,

Frank, Ian,

Williamson, Carolyn,

Cohen, Myron S,

Ledgerwood, Julie E,

Mgodi, Nyaradzo M,

Laher, Fatima,

Kublin, James G,

Cabello, Robinson,

Mullins, James I,

Montefiori, David C,

Mukwekwerere, Pamela G,

McElrath, M. Juliana,

Bentley, Carter

2021

Overview

Two phase 2 trials assessed the efficacy and safety of intravenous infusions of a broadly neutralizing antibody, VRCO1, to prevent HIV-1 infection. VRC01 did not cause adverse events and did not prevent overall HIV-1 acquisition significantly more effectively than placebo. In secondary analyses, VRC01 prevented transmission of VRC01-sensitive HIV-1 isolates.

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Publisher

Massachusetts Medical Society

Subject

Adolescent

/ Adult

/ Adverse events

/ Africa South of the Sahara - epidemiology

/ Allergies

/ Americas - epidemiology

/ Antibodies