ArticleStatistical communications in infectious diseases2011
A Sequential Phase 2b Trial Design for Evaluating Vaccine Efficacy and Immune Correlates for Multiple HIV Vaccine Regimens.
Article in Statistical communications in infectious diseases, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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
21 citing papers in PubMed, 32 citations in OpenAlex.
- Vaccine Efficacy of ALVAC-HIV and Bivalent Subtype C gp120-MF59 in Adults.The New England journal of medicine · 2021Trial
- Designing HIV Vaccine Efficacy Trials in the Context of Highly Effective Non-vaccine Prevention Modalities.Statistics in biosciences · 2020Article
- Methods for Feature Selection in Down-Selection of Vaccine Regimens Based on Multivariate Immune Response Endpoints.Statistics in biosciences · 2020Article
- Design of vaccine efficacy trials during public health emergencies.Science translational medicine · 2019Review
- Simultaneous Inference of Treatment Effect Modification by Intermediate Response Endpoint Principal Strata with Application to Vaccine Trials.The international journal of biostatistics · 2019Article
- Taking stock of the present and looking ahead: envisioning challenges in the design of future HIV prevention efficacy trials.The lancet. HIV · 2019Review
- Statistical methods for down-selection of treatment regimens based on multiple endpoints, with application to HIV vaccine trials.Biostatistics (Oxford, England) · 2017Article
- Basis and Statistical Design of the Passive HIV-1 Antibody Mediated Prevention (AMP) Test-of-Concept Efficacy Trials.Statistical communications in infectious diseases · 2017Article
- Modeling HIV vaccine trials of the future.Current opinion in HIV and AIDS · 2016Review
- Power/sample size calculations for assessing correlates of risk in clinical efficacy trials.Statistics in medicine · 2016Article
- Selection of HIV vaccine candidates for concurrent testing in an efficacy trial.Current opinion in virology · 2016Review
- Immune correlates of vaccine protection against HIV-1 acquisition.Science translational medicine · 2015Review
- Surrogate Endpoint Evaluation: Principal Stratification Criteria and the Prentice Definition.Journal of causal inference · 2015Article
- Recent developments in clinical trial designs for HIV vaccine research.Human vaccines & immunotherapeutics · 2015Review
- Evaluating principal surrogate endpoints with time-to-event data accounting for time-varying treatment efficacy.Biostatistics (Oxford, England) · 2014Article
- Article
- In pursuit of an HIV vaccine: designing efficacy trials in the context of partially effective nonvaccine prevention modalities.AIDS research and human retroviruses · 2013Article
- Lessons learned from HIV vaccine clinical efficacy trials.Current HIV research · 2013Review
- New clinical trial designs for HIV vaccine evaluation.Current opinion in HIV and AIDS · 2013Review
- Design and estimation for evaluating principal surrogate markers in vaccine trials.Biometrics · 2013Article
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 2 countries.
Funding
Abstract
Five preventative HIV vaccine efficacy trials have been conducted over the last 12 years, all of which evaluated vaccine efficacy (VE) to prevent HIV infection for a single vaccine regimen versus placebo. Now that one of these trials has supported partial VE of a prime-boost vaccine regimen, there is interest in conducting efficacy trials that simultaneously evaluate multiple prime-boost vaccine regimens against a shared placebo group in the same geographic region, for accelerating the pace of vaccine development. This article proposes such a design, which has main objectives (1) to evaluate VE of each regimen versus placebo against HIV exposures occurring near the time of the immunizations; (2) to evaluate durability of VE for each vaccine regimen showing reliable evidence for positive VE; (3) to expeditiously evaluate the immune correlates of protection if any vaccine regimen shows reliable evidence for positive VE; and (4) to compare VE among the vaccine regimens. The design uses sequential monitoring for the events of vaccine harm, non-efficacy, and high efficacy, selected to weed out poor vaccines as rapidly as possible while guarding against prematurely weeding out a vaccine that does not confer efficacy until most of the immunizations are received. The evaluation of the design shows that testing multiple vaccine regimens is important for providing a well-powered assessment of the correlation of vaccine-induced immune responses with HIV infection, and is critically important for providing a reasonably powered assessment of the value of identified correlates as surrogate endpoints for HIV infection.
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.