Trial reportHuman vaccines & immunotherapeutics2018
Modeling cumulative overall prevention efficacy for the VRC01 phase 2b efficacy trials.
Trial report in Human vaccines & immunotherapeutics, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
14 citing papers in PubMed, 1 synthesis or guideline pooled it, 20 citations in OpenAlex.
- A Meta-analysis of Passive Immunization Studies Shows that Serum-Neutralizing Antibody Titer Associates with Protection against SHIV Challenge.Cell host & microbe · 2019Pooled it
- Mechanisms of Immune Evasion in HIV-1: The Role of Virus-Host Protein Interactions.Current issues in molecular biology · 2025Review
- Application of the SLAPNAP statistical learning tool to broadly neutralizing antibody HIV prevention research.iScience · 2023Article
- Broadly neutralizing monoclonal antibodies for HIV prevention.Journal of the International AIDS Society · 2021Article
- Timing HIV infection with a simple and accurate population viral dynamics model.Journal of the Royal Society, Interface · 2021Article
- Patient-Focused Selection of PrEP Medication for Individuals at Risk of HIV: A Narrative Review.Infectious diseases and therapy · 2021Review
- Clinical Trials of Broadly Neutralizing Monoclonal Antibodies for Human Immunodeficiency Virus Prevention: A Review.The Journal of infectious diseases · 2021Review
- Pre-existing resistance in the latent reservoir can compromise VRC01 therapy during chronic HIV-1 infection.PLoS computational biology · 2020Article
- Mathematical modeling to reveal breakthrough mechanisms in the HIV Antibody Mediated Prevention (AMP) trials.PLoS computational biology · 2020Article
- Broadly neutralizing antibodies for the treatment and prevention of HIV infection.Current opinion in HIV and AIDS · 2020Review
- Broadly neutralizing anti-HIV-1 monoclonal antibodies in the clinic.Nature medicine · 2019Review
- Structural Vaccinology for Viral Vaccine Design.Frontiers in microbiology · 2019Review
- Novel Strategies for Malaria Vaccine Design.Frontiers in immunology · 2018Review
- Antibodies and Antibody Derivatives: New Partners in HIV Eradication Strategies.Frontiers in immunology · 2018Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 5 institutions in 1 country.
Funding
Abstract
The Antibody Mediated Prevention trials are assessing whether intravenously-administered VRC01 (10 mg/kg or 30 mg/kg vs placebo) can prevent HIV infection. In a modeling exercise, we used two models to predict the overall prevention efficacy (PE) of each VRC01 dose in preventing HIV infection. For the first per-exposure PE model, parameters were estimated from studies where nonhuman primates (NHPs) were administered high-dose intra-rectal simian-human immunodeficiency virus challenge two days post-VRC01 infusion at various dosages ("NHP model"). To account for the fact that humans may require greater VRC01 concentration to achieve the same level of protection, we next assumed that a 5-fold greater VRC01 serum concentration would be needed to provide the same level of per-exposure PE as seen in the NHP data ("5-fold model"). For the 10 mg/kg regimen, the 5-fold and NHP models predict an overall PE of 37% and 64%, respectively; for the 30 mg/kg regimen, the two models predict an overall PE of 53% and 82%, respectively. Our results support that VRC01 may plausibly confer positive PE in the AMP trials. Given the lack of available knowledge and data to verify the assumptions undergirding our modeling framework, its quantitative predictions of overall PE are preliminary. Its current main applications are to supplement decisions to advance mAb regimens to efficacy trials, and to enable mAb regimen ranking by their potential for PE in humans.
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Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.