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Two Randomized Trials of Neutralizing Antibodies to Prevent HIV-1 Acquisition
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BACKGROUNDWhether a broadly neutralizing antibody (bnAb) can be used to prevent human immunodeficiency virus type 1 (HIV-1) acquisition is unclear. METHODSWe enrolled at-risk cisgender men and transgender persons in the Americas and Europe in the HVTN 704/HPTN 085 trial and at-risk women in sub-Saharan Africa in the HVTN 703/HPTN 081 trial.Participants were randomly assigned to receive, every 8 weeks, infusions of a bnAb (VRC01) at a dose of either 10 or 30 mg per kilogram (low-dose group and high-dose group, respectively) or placebo, for 10 infusions in total.HIV-1 testing was performed every 4 weeks.The VRC01 80% inhibitory concentration (IC 80 ) of acquired isolates was measured with the TZM-bl assay. RESULTSAdverse events were similar in number and severity among the treatment groups within each trial.Among the 2699 participants in HVTN 704/HPTN 085, HIV-1 infection occurred in 32 in the low-dose group, 28 in the high-dose group, and 38 in the placebo group.Among the 1924 participants in HVTN 703/HPTN 081, infection occurred in 28 in the low-dose group, 19 in the high-dose group, and 29 in the placebo group.The incidence of HIV-1 infection per 100 person-years in HVTN 704/ HPTN 085 was 2.35 in the pooled VRC01 groups and 2.98 in the placebo group (estimated prevention efficacy, 26.6%; 95% confidence interval [CI], -11.7 to 51.8; P = 0.15), and the incidence per 100 person-years in HVTN 703/HPTN 081 was 2.49 in the pooled VRC01 groups and 3.10 in the placebo group (estimated prevention efficacy, 8.8%; 95% CI, -45.1 to 42.6; P = 0.70).In prespecified analyses pooling data across the trials, the incidence of infection with VRC01-sensitive isolates (IC 80 <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. CONCLUSIONSVRC01 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 .govnumbers, NCT02716675 and NCT02568215.
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“Notably, the broadly neutralizing mAbs, VRC01, have recently gained attention thanks to their ability to neutralize 98% of HIV strains167 and prevent transmission of antibody-sensitive strains with 75.4% efficacy168.”
From mRNA vaccines for infectious diseases: principles, delivery and clinical translation (2021) · cites this paper as [168]
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- Mahomed S, Garrett N, Baxter C, Abdool Karim Q, Abdool Karim SS. Clinical trials of broadly neutralizing monoclonal antibodies for HIV prevention: a review. J Infect Dis 2020 June 30 (Epub ahead of print).32604408
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Metadata
- Authors
- Corey, L., Gilbert, P. B., Juraska, M., Montefiori, D. C., Morris, L., Karuna, S. T., Edupuganti, S., Mgodi, N. M., deCamp, A. C., Rudnicki, E., Huang, Y., Gonzales, P., Cabello, R., Orrell, C., Lama, J. R., Laher, F., Lazarus, E. M., Sanchez, J., Frank, I., Hinojosa, J., Sobieszczyk, M. E., Marshall, K. E., Mukwekwerere, P. G., Makhema, J., Baden, L. R., Mullins, J. I., Williamson, C., Hural, J., McElrath, M. J., Bentley, C., Takuva, S., Gomez Lorenzo, M. M., Burns, D. N., Espy, N., Randhawa, A. K., Kochar, N., Piwowar-Manning, E., Donnell, D. J., Sista, N., Andrew, P., Kublin, J. G., Gray, G., Ledgerwood, J. E., Mascola, J. R., & Cohen, M. S.
- Affiliations
- University of the Witwatersrand (ZA)
- National Health Laboratory Service (ZA)
- Emory University (US)
- University of Zimbabwe (ZW)
- From the Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center (L.C., P.B.G., M.J., S.T.K., A.C.C., E.R., Y.H., K.E.M., J. Hural, M.J.M.E., C.B., S.T., N.E., A.K.R., N.K., D.J.D., J.G.K., G.G.), and the Departments of Global Health, Microbiology, and Medicine, University of Washington (J.I.M.), Seattle; the Department of Surgery and Duke Human Vaccine Institute, Duke University Medical Center (D.C.M.), and FHI 360 (N.S., P.A.), Durham, and the Institute for Global Health and Infectious Disease, University of North Carolina, Chapel Hill (M.S.C.) — both in North Carolina; the National Institute for Communicable Diseases of the National Health Laboratory Service (L.M.) and the Antibody Immunity Research Unit, Faculty of Health Sciences (L.M.), and the Perinatal HIV Research Unit, Faculty of Health Sciences (F.L., E.M.L., S.T.), University of the Witwatersrand, Johannesburg, the Desmond Tutu HIV Centre, Department of Medicine and Institute of Infectious Disease and Molecular Medicine ...
- Brigham and Women's Hospital (US)
- University of Cape Town (ZA)
- Family Health International 360 (US)
- South African Medical Research Council (ZA)
- University of North Carolina at Chapel Hill (US)
- ORCID
- Corey, Lawrence
- Gilbert, Peter B.
- Juraska, Michal
- Montefiori, David C.
- Morris, Lynn
- Karuna, Shelly T.
- Edupuganti, Srilatha
- Mgodi, Nyaradzo M.
- deCamp, Allan C.
- Huang, Yunda
- Cabello, Robinson
- Orrell, Catherine
- Lama, Javier R.
- Laher, Fatima
- Lazarus, Erica M.
- Frank, Ian
- Sobieszczyk, Magdalena E.
- Marshall, Kyle E.
- Mukwekwerere, Pamela G.
- Makhema, Joseph
- Baden, Lindsey R.
- Mullins, James I.
- Williamson, Carolyn
- Hural, John
- McElrath, M. Juliana
- Takuva, Simbarashe
- Burns, David N.
- Espy, Nicole
- Randhawa, April K.
- Donnell, Deborah J.
- Andrew, Philip
- Kublin, James G.
- Gray, Glenda
- Ledgerwood, Julie E.
- Mascola, John R.
- Cohen, Myron S.
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2021-03-18
- Volume
- 384
- Issue
- 11
- Pages
- 1003-1014
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- PMC
- PMC8189692
- OpenAlex
- W3138945586
- Cited by
- 538
- References
- 31
- Citations by year
- 2026: 87 · 2025: 108 · 2024: 98 · 2023: 98 · 2022: 78 · 2021: 66
- FWCI
- 47.79
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- Carolina Digital Repository (University of North Carolina at Chapel Hill) (submittedVersion)
- IRIS (submittedVersion)
- UpSpace Institutional Repository (University of Pretoria) (submittedVersion)
- SERVAL (Université de Lausanne) (submittedVersion)
- UNC Libraries
- Funders
- National Institute of Allergy and Infectious Diseases (P30 AI027757, UM1 AI068614, UM1 AI068618, UM1 AI068619, UM1 AI068635, UM1AI068613, UM1AI068617)
- Intramural Research Program of the NIH, NIAID
- Topics
- Life Sciences › Immunology and Microbiology › Virology › HIV Research and Treatment
- Health Sciences › Medicine › Infectious Diseases › HIV/AIDS Research and Interventions
- Health Sciences › Medicine › Infectious Diseases › HIV/AIDS drug development and treatment
- Keywords
- HIV-1 prevention, broadly neutralizing antibodies, VRC01, HIV-1 acquisition, HIV-1 envelope glycoprotein, HIV-1 isolates
- MeSH terms
- Proof of Concept Study, Broadly Neutralizing Antibodies, Adolescent, Adult, Americas, Antibodies, Monoclonal, Double-Blind Method, Europe, Female, Humans, Male, HIV Antibodies, HIV-1, HIV Infections, Incidence, Africa South of the Sahara, Young Adult
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