ArticleBiometrics2013
Design and estimation for evaluating principal surrogate markers in vaccine trials.
Article in Biometrics, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 31 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
31 citing papers in PubMed, 50 citations in OpenAlex.
- Immune correlates analysis of mRNA-1345 RSV vaccine efficacy clinical trial.Nature communications · 2025Trial
- Neutralizing Antibody Correlates Analysis of Tetravalent Dengue Vaccine Efficacy Trials in Asia and Latin America.The Journal of infectious diseases · 2018Trial
- Fold rise in antibody titers by measured by glycoprotein-based enzyme-linked immunosorbent assay is an excellent correlate of protection for a herpes zoster vaccine, demonstrated via the vaccine efficacy curve.The Journal of infectious diseases · 2014Trial
- Review
- Efficient Estimation under Data Fusion.Biometrika · 2023Article
- Antibody Correlates of Protection From Severe Respiratory Syncytial Virus Disease in a Vaccine Efficacy Trial.Open forum infectious diseases · 2023Article
- SENSITIVITY ANALYSIS FOR EVALUATING PRINCIPAL SURROGATE ENDPOINTS RELAXING THE EQUAL EARLY CLINICAL RISK ASSUMPTION.The annals of applied statistics · 2022Article
- Evaluation of treatment effect modification by biomarkers measured pre- and post-randomization in the presence of non-monotone missingness.Biostatistics (Oxford, England) · 2022Article
- Change Point Inference in the Presence of Missing Covariates for Principal Surrogate Evaluation in Vaccine Trials.Biometrika · 2021Article
- Innovative trial designs and analyses for vaccine clinical development.Contemporary clinical trials · 2021Article
- Measuring Surrogacy in Clinical Research: With an application to studying surrogate markers for HIV Treatment-as-Prevention.Statistics in biosciences · 2020Article
- Inference on treatment effect modification by biomarker response in a three-phase sampling design.Biostatistics (Oxford, England) · 2020Article
- Predictive cluster level surrogacy in the presence of interference.Biostatistics (Oxford, England) · 2020Article
- Methods for Feature Selection in Down-Selection of Vaccine Regimens Based on Multivariate Immune Response Endpoints.Statistics in biosciences · 2020Article
- Post-randomization Biomarker Effect Modification Analysis in an HIV Vaccine Clinical Trial.Journal of causal inference · 2020Article
- Likelihood-Based Methods for Assessing Principal Surrogate Endpoints in Vaccine Trials.Statistics in biosciences · 2019Article
- Simultaneous Inference of Treatment Effect Modification by Intermediate Response Endpoint Principal Strata with Application to Vaccine Trials.The international journal of biostatistics · 2019Article
- Evaluation and comparison of predictive individual-level general surrogates.Biostatistics (Oxford, England) · 2018Article
- Evaluating principal surrogate markers in vaccine trials in the presence of multiphase sampling.Biometrics · 2018Article
- A method to address between-subject heterogeneity for identification of principal surrogate markers in repeated low-dose challenge HIV vaccine studies.Statistics in medicine · 2017Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors at 3 institutions in 1 country.
Funding
Abstract
In vaccine research, immune biomarkers that can reliably predict a vaccine's effect on the clinical endpoint (i.e., surrogate markers) are important tools for guiding vaccine development. This article addresses issues on optimizing two-phase sampling study design for evaluating surrogate markers in a principal surrogate framework, motivated by the design of a future HIV vaccine trial. To address the problem of missing potential outcomes in a standard trial design, novel trial designs have been proposed that utilize baseline predictors of the immune response biomarker(s) and/or augment the trial by vaccinating uninfected placebo recipients at the end of the trial and measuring their immune biomarkers. However, inefficient use of the augmented information can lead to counter-intuitive results on the precision of estimation. To remedy this problem, we propose a pseudo-score type estimator suitable for the augmented design and characterize its asymptotic properties. This estimator has superior performance compared with existing estimators and allows calculation of analytical variances useful for guiding study design. Based on the new estimator we investigate in detail the problem of optimizing the sampling scheme of a biomarker in a vaccine efficacy trial for efficiently estimating its surrogate effect, as characterized by the vaccine efficacy curve (a causal effect predictiveness curve) and by the predicted overall vaccine efficacy using the biomarker.
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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.