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Review
. 2021 Feb 13;223(3):370-380.
doi: 10.1093/infdis/jiaa377.

Clinical Trials of Broadly Neutralizing Monoclonal Antibodies for Human Immunodeficiency Virus Prevention: A Review

Sharana Mahomed  1 , Nigel Garrett  1   2 , Cheryl Baxter  1 , Quarraisha Abdool Karim  1   3 , Salim S Abdool Karim  1   3
Affiliations
Review

Clinical Trials of Broadly Neutralizing Monoclonal Antibodies for Human Immunodeficiency Virus Prevention: A Review

Sharana Mahomed et al. J Infect Dis. .

Abstract

Passive immunization with broadly neutralizing antibodies (bnAbs) is a promising approach to reduce the 1.7 million annual human immunodeficiency virus (HIV) infections globally. Early studies on bnAbs showed safety in humans, but short elimination half-lives and low potency and breadth. Since 2010, several new highly potent bnAbs have been assessed in clinical trials alone or in combination for HIV prevention. Published data indicate that these bnAbs are safe and have a half-life ranging from 15 to 71 days. Only intravenous VRC01 has advanced to an efficacy trial, with results expected in late 2020. If bnAbs are shown to be effective in preventing HIV infection, they could fast-track vaccine development as correlates of protection, and contribute as passive immunization to achieving the goal of epidemic control. The purpose of the current review is to describe the current status and provide a synopsis of the available data on bnAbs in clinical trials for HIV prevention.

Keywords: HIV; broadly neutralizing antibodies; clinical trials; monoclonal antibodies.

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Figures

Figure 1.
Figure 1.
Milestones of antibody development for clinical use. Abbreviation: bnAbs, broadly neutralizing antibodies.
Figure 2.
Figure 2.
Human immunodeficiency virus (HIV)–specific neutralizing antibody targets with broadly neutralizing antibody (bnAb) candidates in ongoing (green), completed (black), and paused (red) clinical trials. Candidate bnAbs in clinical development (orange) are included here for completeness but are not included in the review. Abbreviations: gp, glycoprotein; MPER, membrane-proximal external region.
Figure 3.
Figure 3.
Search methods and results. Abbreviations: bnAbs, broadly neutralizing antibodies; HIV, human immunodeficiency virus; ICTRP, International Clinical Trials Registry Platform.
See this image and copyright information in PMC

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