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

BACKGROUND: Whether a broadly neutralizing antibody (bnAb) can be used to prevent human immunodeficiency virus type 1 (HIV-1) acquisition is unclear. METHODS: ) of acquired isolates was measured with the TZM-bl assay. RESULTS: <1 μg per milliliter) per 100 person-years was 0.20 among VRC01 recipi...

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Autores principales: Lawrence Corey, Peter B. Gilbert, Michal Juraska, David C. Montefiori, Lynn Morris, Shelly Karuna, Srilatha Edupuganti, Nyaradzo Mgodi, Allan C. deCamp, Erika Rudnicki, Yunda Huang, Pedro Gonzáles, Robinson Cabello, Catherine Orrell, Javier R. Lama, Fatima Laher, Erica Lazarus, Jorge Sánchez, Ian Frank, Juan Hinojosa, Magdalena E. Sobieszczyk, Kyle Marshall, Pamela Mukwekwerere, Joseph Makhema, Lindsey R. Baden, James I. Mullins, Carolyn Williamson, John Hural, M. Juliana McElrath, Carter Bentley, Simbarashe Takuva, Margarita M. Gomez Lorenzo, David Burns, Nicole Espy, April K. Randhawa, Nidhi Kochar, Estelle Piwowar‐Manning, Deborah Donnell, Nirupama Sista, P. Andrew, James G. Kublin, Glenda Gray, Julie E. Ledgerwood, John R. Mascola, Myron S. Cohen
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Lenguaje:inglés
Publicado: 2021
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author Lawrence Corey
Peter B. Gilbert
Michal Juraska
David C. Montefiori
Lynn Morris
Shelly Karuna
Srilatha Edupuganti
Nyaradzo Mgodi
Allan C. deCamp
Erika Rudnicki
Yunda Huang
Pedro Gonzáles
Robinson Cabello
Catherine Orrell
Javier R. Lama
Fatima Laher
Erica Lazarus
Jorge Sánchez
Ian Frank
Juan Hinojosa
Magdalena E. Sobieszczyk
Kyle Marshall
Pamela Mukwekwerere
Joseph Makhema
Lindsey R. Baden
James I. Mullins
Carolyn Williamson
John Hural
M. Juliana McElrath
Carter Bentley
Simbarashe Takuva
Margarita M. Gomez Lorenzo
David Burns
Nicole Espy
April K. Randhawa
Nidhi Kochar
Estelle Piwowar‐Manning
Deborah Donnell
Nirupama Sista
P. Andrew
James G. Kublin
Glenda Gray
Julie E. Ledgerwood
John R. Mascola
Myron S. Cohen
author_browse Allan C. deCamp
April K. Randhawa
Carolyn Williamson
Carter Bentley
Catherine Orrell
David Burns
David C. Montefiori
Deborah Donnell
Erica Lazarus
Erika Rudnicki
Estelle Piwowar‐Manning
Fatima Laher
Glenda Gray
Ian Frank
James G. Kublin
James I. Mullins
Javier R. Lama
John Hural
John R. Mascola
Jorge Sánchez
Joseph Makhema
Juan Hinojosa
Julie E. Ledgerwood
Kyle Marshall
Lawrence Corey
Lindsey R. Baden
Lynn Morris
M. Juliana McElrath
Magdalena E. Sobieszczyk
Margarita M. Gomez Lorenzo
Michal Juraska
Myron S. Cohen
Nicole Espy
Nidhi Kochar
Nirupama Sista
Nyaradzo Mgodi
P. Andrew
Pamela Mukwekwerere
Pedro Gonzáles
Peter B. Gilbert
Robinson Cabello
Shelly Karuna
Simbarashe Takuva
Srilatha Edupuganti
Yunda Huang
author_facet Lawrence Corey
Peter B. Gilbert
Michal Juraska
David C. Montefiori
Lynn Morris
Shelly Karuna
Srilatha Edupuganti
Nyaradzo Mgodi
Allan C. deCamp
Erika Rudnicki
Yunda Huang
Pedro Gonzáles
Robinson Cabello
Catherine Orrell
Javier R. Lama
Fatima Laher
Erica Lazarus
Jorge Sánchez
Ian Frank
Juan Hinojosa
Magdalena E. Sobieszczyk
Kyle Marshall
Pamela Mukwekwerere
Joseph Makhema
Lindsey R. Baden
James I. Mullins
Carolyn Williamson
John Hural
M. Juliana McElrath
Carter Bentley
Simbarashe Takuva
Margarita M. Gomez Lorenzo
David Burns
Nicole Espy
April K. Randhawa
Nidhi Kochar
Estelle Piwowar‐Manning
Deborah Donnell
Nirupama Sista
P. Andrew
James G. Kublin
Glenda Gray
Julie E. Ledgerwood
John R. Mascola
Myron S. Cohen
author_sort Lawrence Corey
collection Producción científica
description BACKGROUND: Whether a broadly neutralizing antibody (bnAb) can be used to prevent human immunodeficiency virus type 1 (HIV-1) acquisition is unclear. METHODS: ) of acquired isolates was measured with the TZM-bl assay. RESULTS: <1 μg per milliliter) per 100 person-years was 0.20 among VRC01 recipients and 0.86 among placebo recipients (estimated prevention efficacy, 75.4%; 95% CI, 45.5 to 88.9). The prevention efficacy against sensitive isolates was similar for each VRC01 dose and trial; VRC01 did not prevent acquisition of other HIV-1 isolates. CONCLUSIONS: VRC01 did not prevent overall HIV-1 acquisition more effectively than placebo, but analyses of VRC01-sensitive HIV-1 isolates provided proof-of-concept that bnAb prophylaxis can be effective. (Supported by the National Institute of Allergy and Infectious Diseases; HVTN 704/HPTN 085 and HVTN 703/HPTN 081 ClinicalTrials.gov numbers, NCT02716675 and NCT02568215.).
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spelling oai:cris.upeu.edu.pe:20.500.15037/17632026-10-30T16:16:43ZTwo Randomized Trials of Neutralizing Antibodies to Prevent HIV-1 AcquisitionLawrence CoreyPeter B. GilbertMichal JuraskaDavid C. MontefioriLynn MorrisShelly KarunaSrilatha EdupugantiNyaradzo MgodiAllan C. deCampErika RudnickiYunda HuangPedro GonzálesRobinson CabelloCatherine OrrellJavier R. LamaFatima LaherErica LazarusJorge SánchezIan FrankJuan HinojosaMagdalena E. SobieszczykKyle MarshallPamela MukwekwerereJoseph MakhemaLindsey R. BadenJames I. MullinsCarolyn WilliamsonJohn HuralM. Juliana McElrathCarter BentleySimbarashe TakuvaMargarita M. Gomez LorenzoDavid BurnsNicole EspyApril K. RandhawaNidhi KocharEstelle Piwowar‐ManningDeborah DonnellNirupama SistaP. AndrewJames G. KublinGlenda GrayJulie E. LedgerwoodJohn R. MascolaMyron S. CohenHuman immunodeficiency virus (HIV)AntibodyVirologyNeutralizing antibodyVirusImmunologyMedicineHuman immunodeficiency virus (HIV)AntibodyVirologyNeutralizing antibodyVirusImmunologyMedicineProof of Concept StudyProof of Concept StudyProof of Concept StudyProof of Concept StudyProof of Concept StudyBroadly Neutralizing Antibodies adverse effectsBroadly Neutralizing Antibodies adverse effectsBroadly Neutralizing Antibodies adverse effectsBroadly Neutralizing Antibodies adverse effectsBroadly Neutralizing Antibodies adverse effectsBroadly Neutralizing Antibodies therapeutic useBroadly Neutralizing Antibodies therapeutic useBroadly Neutralizing Antibodies therapeutic useBroadly Neutralizing Antibodies therapeutic useBroadly Neutralizing Antibodies therapeutic useAdolescentAdolescentAdolescentAdolescentAdolescentAdultAdultAdultAdultAdultAmericas epidemiologyAmericas epidemiologyAmericas epidemiologyAmericas epidemiologyAmericas epidemiologyAntibodies, Monoclonal adverse effectsAntibodies, Monoclonal adverse effectsAntibodies, Monoclonal adverse effectsAntibodies, Monoclonal adverse effectsAntibodies, Monoclonal adverse effectsAntibodies, Monoclonal therapeutic useAntibodies, Monoclonal therapeutic useAntibodies, Monoclonal therapeutic useAntibodies, Monoclonal therapeutic useAntibodies, Monoclonal therapeutic useDouble-Blind MethodDouble-Blind MethodDouble-Blind MethodDouble-Blind MethodDouble-Blind MethodEurope epidemiologyEurope epidemiologyEurope epidemiologyEurope epidemiologyEurope epidemiologyFemaleFemaleFemaleFemaleFemaleHumansHumansHumansHumansHumansMaleMaleMaleMaleMaleHIV Antibodies adverse effectsHIV Antibodies adverse effectsHIV Antibodies adverse effectsHIV Antibodies adverse effectsHIV Antibodies adverse effectsHIV Antibodies therapeutic useHIV Antibodies therapeutic useHIV Antibodies therapeutic useHIV Antibodies therapeutic useHIV Antibodies therapeutic useHIV-1 drug effectsHIV-1 drug effectsHIV-1 drug effectsHIV-1 drug effectsHIV-1 drug effectsHIV Infections epidemiologyHIV Infections epidemiologyHIV Infections epidemiologyHIV Infections epidemiologyHIV Infections epidemiologyHIV Infections prevention & controlHIV Infections prevention & controlHIV Infections prevention & controlHIV Infections prevention & controlHIV Infections prevention & controlIncidenceIncidenceIncidenceIncidenceIncidenceAfrica South of the Sahara epidemiologyAfrica South of the Sahara epidemiologyAfrica South of the Sahara epidemiologyAfrica South of the Sahara epidemiologyAfrica South of the Sahara epidemiologyYoung AdultYoung AdultYoung AdultYoung AdultYoung AdultLife Sciences Immunology and Microbiology Virology HIV Research and TreatmentHealth Sciences Medicine Infectious Diseases HIV/AIDS drug development and treatmentLife Sciences Biochemistry, Genetics and Molecular Biology Molecular Biology Biological Research and Disease StudiesBACKGROUND: Whether a broadly neutralizing antibody (bnAb) can be used to prevent human immunodeficiency virus type 1 (HIV-1) acquisition is unclear. METHODS: ) of acquired isolates was measured with the TZM-bl assay. RESULTS: <1 μg per milliliter) per 100 person-years was 0.20 among VRC01 recipients and 0.86 among placebo recipients (estimated prevention efficacy, 75.4%; 95% CI, 45.5 to 88.9). The prevention efficacy against sensitive isolates was similar for each VRC01 dose and trial; VRC01 did not prevent acquisition of other HIV-1 isolates. CONCLUSIONS: VRC01 did not prevent overall HIV-1 acquisition more effectively than placebo, but analyses of VRC01-sensitive HIV-1 isolates provided proof-of-concept that bnAb prophylaxis can be effective. (Supported by the National Institute of Allergy and Infectious Diseases; HVTN 704/HPTN 085 and HVTN 703/HPTN 081 ClinicalTrials.gov numbers, NCT02716675 and NCT02568215.).Articlehttps://pubmed.ncbi.nlm.nih.gov/33730454https://www.nejm.org/doi/pdf/10.1056/NEJMoa2031738?articleTools=truehttps://doi.org/10.1056/nejmoa203173810.1056/nejmoa2031738https://hdl.handle.net/20.500.15037/1763W3138945586enNew England Journal of Medicine0028-47931533-44062021-03-172026-06-13T14:21:46Z2026-06-13T14:21:46Z
spellingShingle Human immunodeficiency virus (HIV)
Antibody
Virology
Neutralizing antibody
Virus
Immunology
Medicine
Human immunodeficiency virus (HIV)
Antibody
Virology
Neutralizing antibody
Virus
Immunology
Medicine
Proof of Concept Study
Proof of Concept Study
Proof of Concept Study
Proof of Concept Study
Proof of Concept Study
Broadly Neutralizing Antibodies adverse effects
Broadly Neutralizing Antibodies adverse effects
Broadly Neutralizing Antibodies adverse effects
Broadly Neutralizing Antibodies adverse effects
Broadly Neutralizing Antibodies adverse effects
Broadly Neutralizing Antibodies therapeutic use
Broadly Neutralizing Antibodies therapeutic use
Broadly Neutralizing Antibodies therapeutic use
Broadly Neutralizing Antibodies therapeutic use
Broadly Neutralizing Antibodies therapeutic use
Adolescent
Adolescent
Adolescent
Adolescent
Adolescent
Adult
Adult
Adult
Adult
Adult
Americas epidemiology
Americas epidemiology
Americas epidemiology
Americas epidemiology
Americas epidemiology
Antibodies, Monoclonal adverse effects
Antibodies, Monoclonal adverse effects
Antibodies, Monoclonal adverse effects
Antibodies, Monoclonal adverse effects
Antibodies, Monoclonal adverse effects
Antibodies, Monoclonal therapeutic use
Antibodies, Monoclonal therapeutic use
Antibodies, Monoclonal therapeutic use
Antibodies, Monoclonal therapeutic use
Antibodies, Monoclonal therapeutic use
Double-Blind Method
Double-Blind Method
Double-Blind Method
Double-Blind Method
Double-Blind Method
Europe epidemiology
Europe epidemiology
Europe epidemiology
Europe epidemiology
Europe epidemiology
Female
Female
Female
Female
Female
Humans
Humans
Humans
Humans
Humans
Male
Male
Male
Male
Male
HIV Antibodies adverse effects
HIV Antibodies adverse effects
HIV Antibodies adverse effects
HIV Antibodies adverse effects
HIV Antibodies adverse effects
HIV Antibodies therapeutic use
HIV Antibodies therapeutic use
HIV Antibodies therapeutic use
HIV Antibodies therapeutic use
HIV Antibodies therapeutic use
HIV-1 drug effects
HIV-1 drug effects
HIV-1 drug effects
HIV-1 drug effects
HIV-1 drug effects
HIV Infections epidemiology
HIV Infections epidemiology
HIV Infections epidemiology
HIV Infections epidemiology
HIV Infections epidemiology
HIV Infections prevention & control
HIV Infections prevention & control
HIV Infections prevention & control
HIV Infections prevention & control
HIV Infections prevention & control
Incidence
Incidence
Incidence
Incidence
Incidence
Africa South of the Sahara epidemiology
Africa South of the Sahara epidemiology
Africa South of the Sahara epidemiology
Africa South of the Sahara epidemiology
Africa South of the Sahara epidemiology
Young Adult
Young Adult
Young Adult
Young Adult
Young Adult
Life Sciences Immunology and Microbiology Virology HIV Research and Treatment
Health Sciences Medicine Infectious Diseases HIV/AIDS drug development and treatment
Life Sciences Biochemistry, Genetics and Molecular Biology Molecular Biology Biological Research and Disease Studies
Lawrence Corey
Peter B. Gilbert
Michal Juraska
David C. Montefiori
Lynn Morris
Shelly Karuna
Srilatha Edupuganti
Nyaradzo Mgodi
Allan C. deCamp
Erika Rudnicki
Yunda Huang
Pedro Gonzáles
Robinson Cabello
Catherine Orrell
Javier R. Lama
Fatima Laher
Erica Lazarus
Jorge Sánchez
Ian Frank
Juan Hinojosa
Magdalena E. Sobieszczyk
Kyle Marshall
Pamela Mukwekwerere
Joseph Makhema
Lindsey R. Baden
James I. Mullins
Carolyn Williamson
John Hural
M. Juliana McElrath
Carter Bentley
Simbarashe Takuva
Margarita M. Gomez Lorenzo
David Burns
Nicole Espy
April K. Randhawa
Nidhi Kochar
Estelle Piwowar‐Manning
Deborah Donnell
Nirupama Sista
P. Andrew
James G. Kublin
Glenda Gray
Julie E. Ledgerwood
John R. Mascola
Myron S. Cohen
Two Randomized Trials of Neutralizing Antibodies to Prevent HIV-1 Acquisition
title Two Randomized Trials of Neutralizing Antibodies to Prevent HIV-1 Acquisition
title_full Two Randomized Trials of Neutralizing Antibodies to Prevent HIV-1 Acquisition
title_fullStr Two Randomized Trials of Neutralizing Antibodies to Prevent HIV-1 Acquisition
title_full_unstemmed Two Randomized Trials of Neutralizing Antibodies to Prevent HIV-1 Acquisition
title_short Two Randomized Trials of Neutralizing Antibodies to Prevent HIV-1 Acquisition
title_sort two randomized trials of neutralizing antibodies to prevent hiv 1 acquisition
topic Human immunodeficiency virus (HIV)
Antibody
Virology
Neutralizing antibody
Virus
Immunology
Medicine
Human immunodeficiency virus (HIV)
Antibody
Virology
Neutralizing antibody
Virus
Immunology
Medicine
Proof of Concept Study
Proof of Concept Study
Proof of Concept Study
Proof of Concept Study
Proof of Concept Study
Broadly Neutralizing Antibodies adverse effects
Broadly Neutralizing Antibodies adverse effects
Broadly Neutralizing Antibodies adverse effects
Broadly Neutralizing Antibodies adverse effects
Broadly Neutralizing Antibodies adverse effects
Broadly Neutralizing Antibodies therapeutic use
Broadly Neutralizing Antibodies therapeutic use
Broadly Neutralizing Antibodies therapeutic use
Broadly Neutralizing Antibodies therapeutic use
Broadly Neutralizing Antibodies therapeutic use
Adolescent
Adolescent
Adolescent
Adolescent
Adolescent
Adult
Adult
Adult
Adult
Adult
Americas epidemiology
Americas epidemiology
Americas epidemiology
Americas epidemiology
Americas epidemiology
Antibodies, Monoclonal adverse effects
Antibodies, Monoclonal adverse effects
Antibodies, Monoclonal adverse effects
Antibodies, Monoclonal adverse effects
Antibodies, Monoclonal adverse effects
Antibodies, Monoclonal therapeutic use
Antibodies, Monoclonal therapeutic use
Antibodies, Monoclonal therapeutic use
Antibodies, Monoclonal therapeutic use
Antibodies, Monoclonal therapeutic use
Double-Blind Method
Double-Blind Method
Double-Blind Method
Double-Blind Method
Double-Blind Method
Europe epidemiology
Europe epidemiology
Europe epidemiology
Europe epidemiology
Europe epidemiology
Female
Female
Female
Female
Female
Humans
Humans
Humans
Humans
Humans
Male
Male
Male
Male
Male
HIV Antibodies adverse effects
HIV Antibodies adverse effects
HIV Antibodies adverse effects
HIV Antibodies adverse effects
HIV Antibodies adverse effects
HIV Antibodies therapeutic use
HIV Antibodies therapeutic use
HIV Antibodies therapeutic use
HIV Antibodies therapeutic use
HIV Antibodies therapeutic use
HIV-1 drug effects
HIV-1 drug effects
HIV-1 drug effects
HIV-1 drug effects
HIV-1 drug effects
HIV Infections epidemiology
HIV Infections epidemiology
HIV Infections epidemiology
HIV Infections epidemiology
HIV Infections epidemiology
HIV Infections prevention & control
HIV Infections prevention & control
HIV Infections prevention & control
HIV Infections prevention & control
HIV Infections prevention & control
Incidence
Incidence
Incidence
Incidence
Incidence
Africa South of the Sahara epidemiology
Africa South of the Sahara epidemiology
Africa South of the Sahara epidemiology
Africa South of the Sahara epidemiology
Africa South of the Sahara epidemiology
Young Adult
Young Adult
Young Adult
Young Adult
Young Adult
Life Sciences Immunology and Microbiology Virology HIV Research and Treatment
Health Sciences Medicine Infectious Diseases HIV/AIDS drug development and treatment
Life Sciences Biochemistry, Genetics and Molecular Biology Molecular Biology Biological Research and Disease Studies
topic_facet Human immunodeficiency virus (HIV)
Antibody
Virology
Neutralizing antibody
Virus
Immunology
Medicine
Human immunodeficiency virus (HIV)
Antibody
Virology
Neutralizing antibody
Virus
Immunology
Medicine
Proof of Concept Study
Proof of Concept Study
Proof of Concept Study
Proof of Concept Study
Proof of Concept Study
Broadly Neutralizing Antibodies adverse effects
Broadly Neutralizing Antibodies adverse effects
Broadly Neutralizing Antibodies adverse effects
Broadly Neutralizing Antibodies adverse effects
Broadly Neutralizing Antibodies adverse effects
Broadly Neutralizing Antibodies therapeutic use
Broadly Neutralizing Antibodies therapeutic use
Broadly Neutralizing Antibodies therapeutic use
Broadly Neutralizing Antibodies therapeutic use
Broadly Neutralizing Antibodies therapeutic use
Adolescent
Adolescent
Adolescent
Adolescent
Adolescent
Adult
Adult
Adult
Adult
Adult
Americas epidemiology
Americas epidemiology
Americas epidemiology
Americas epidemiology
Americas epidemiology
Antibodies, Monoclonal adverse effects
Antibodies, Monoclonal adverse effects
Antibodies, Monoclonal adverse effects
Antibodies, Monoclonal adverse effects
Antibodies, Monoclonal adverse effects
Antibodies, Monoclonal therapeutic use
Antibodies, Monoclonal therapeutic use
Antibodies, Monoclonal therapeutic use
Antibodies, Monoclonal therapeutic use
Antibodies, Monoclonal therapeutic use
Double-Blind Method
Double-Blind Method
Double-Blind Method
Double-Blind Method
Double-Blind Method
Europe epidemiology
Europe epidemiology
Europe epidemiology
Europe epidemiology
Europe epidemiology
Female
Female
Female
Female
Female
Humans
Humans
Humans
Humans
Humans
Male
Male
Male
Male
Male
HIV Antibodies adverse effects
HIV Antibodies adverse effects
HIV Antibodies adverse effects
HIV Antibodies adverse effects
HIV Antibodies adverse effects
HIV Antibodies therapeutic use
HIV Antibodies therapeutic use
HIV Antibodies therapeutic use
HIV Antibodies therapeutic use
HIV Antibodies therapeutic use
HIV-1 drug effects
HIV-1 drug effects
HIV-1 drug effects
HIV-1 drug effects
HIV-1 drug effects
HIV Infections epidemiology
HIV Infections epidemiology
HIV Infections epidemiology
HIV Infections epidemiology
HIV Infections epidemiology
HIV Infections prevention & control
HIV Infections prevention & control
HIV Infections prevention & control
HIV Infections prevention & control
HIV Infections prevention & control
Incidence
Incidence
Incidence
Incidence
Incidence
Africa South of the Sahara epidemiology
Africa South of the Sahara epidemiology
Africa South of the Sahara epidemiology
Africa South of the Sahara epidemiology
Africa South of the Sahara epidemiology
Young Adult
Young Adult
Young Adult
Young Adult
Young Adult
Life Sciences Immunology and Microbiology Virology HIV Research and Treatment
Health Sciences Medicine Infectious Diseases HIV/AIDS drug development and treatment
Life Sciences Biochemistry, Genetics and Molecular Biology Molecular Biology Biological Research and Disease Studies
url https://pubmed.ncbi.nlm.nih.gov/33730454
https://www.nejm.org/doi/pdf/10.1056/NEJMoa2031738?articleTools=true
https://doi.org/10.1056/nejmoa2031738
https://hdl.handle.net/20.500.15037/1763
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