Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2021 May 1;87(1):680-687.
doi: 10.1097/QAI.0000000000002649.

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

Nyaradzo M Mgodi  1 , Simbarashe Takuva  2   3   4 , Srilatha Edupuganti  5 , Shelly Karuna  2 , Philip Andrew  6 , Erica Lazarus  3 , Precious Garnett  7 , Emily Shava  8   9 , Pamela G Mukwekwerere  1 , Nidhi Kochar  2 , Kyle Marshall  2 , Erika Rudnicki  2 , Michal Juraska  2 , Maija Anderson  2 , Carissa Karg  2 , India Tindale  2 , Elizabeth Greene  6 , Nandisile Luthuli  2 , Kagisho Baepanye  2 , John Hural  2 , Margarita M Gomez Lorenzo  10 , David Burns  10 , Maurine D Miner  2 , Julie Ledgerwood  11 , John R Mascola  11 , Deborah Donnell  2 , Myron S Cohen  6 , Lawrence Corey  2 ; HVTN 703/HPTN 081 Team
Affiliations

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

Nyaradzo M Mgodi et al. J Acquir Immune Defic Syndr. .

Abstract

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 acquisition in heterosexual women between the ages of 18 and 50 years at risk of HIV. Participants were enrolled at 20 sites in Botswana, Kenya, Malawi, Mozambique, South Africa, Tanzania, and Zimbabwe. It is one of the 2 Antibody Mediated Prevention efficacy trials, with HIV Vaccine Trials Network 704/HIV Prevention Trials Network 085, evaluating VRC01 for HIV prevention.

Methods: Intense community engagement was used to optimize participant recruitment and retention. Participants were randomly assigned to receive intravenous VRC01 10 mg/kg, VRC01 30 mg/kg, or placebo in a 1:1:1 ratio. Infusions were given every 8 weeks with a total of 10 infusions and 104 weeks of follow-up after the first infusion.

Results: Between May 2016 and September 2018, 1924 women from sub-Saharan Africa were enrolled. The median age was 26 years (interquartile range: 22-30), and 98.9% were Black. Sexually transmitted infection prevalence at enrollment included chlamydia (16.9%), trichomonas (7.2%), gonorrhea (5.7%), and syphilis (2.2%). External condoms (83.2%) and injectable contraceptives (61.1%) were the methods of contraception most frequently used by participants. In total, through April 3, 2020, 38,490 clinic visits were completed with a retention rate of 96% and 16,807 infusions administered with an adherence rate of 98%.

Conclusions: This proof-of-concept, large-scale monoclonal antibody study demonstrates the feasibility of conducting complex trials involving intravenous infusions in high incidence populations in sub-Saharan Africa.

Trial registration: ClinicalTrials.gov NCT02716675 NCT02568215.

PubMed Disclaimer

Conflict of interest statement

J.R.M. reports an NIH patent for VRC01. The remaining authors have no conflicts of interest to disclose.

Figures

Figure 1.
Figure 1.
CONSORT diagram.
See this image and copyright information in PMC

References

    1. UNAIDS. UNAIDS Data 2019. Geneva, Switzerland: 2019.
    1. Grant RM, Anderson PL, McMahan V, et al.Uptake of pre-exposure prophylaxis, sexual practices, and HIV incidence in men and transgender women who have sex with men: a cohort study. Lancet Infect Dis. 2014;14(9):820–829. - PMC - PubMed
    1. McCormack S, Dunn DT, Desai M, et al.Pre-exposure prophylaxis to prevent the acquisition of HIV-1 infection (PROUD): effectiveness results from the pilot phase of a pragmatic open-label randomised trial. Lancet. 2016;387(10013):53–60. - PMC - PubMed
    1. Janes H, Corey L, Ramjee G, et al.Weighing the Evidence of Efficacy of Oral PrEP for HIV Prevention in Women in Southern Africa. AIDS Res Hum Retroviruses. 2018;34(8):645–656. - PMC - PubMed
    1. Patterson KB, Prince HA, Kraft E, et al.Penetration of tenofovir and emtricitabine in mucosal tissues: implications for prevention of HIV-1 transmission. Sci Transl Med. 2011;3(112):112re114. - PMC - PubMed

Publication types

MeSH terms

Associated data