Evidence map›Paper›PMID 40971983›Full record

ReviewThe Journal of infectious diseases2025

Immune Correlates and Vaccine Immunobridging: Statistical Innovations, Challenges, and Opportunities.

Marco Carone, Charles J Wolock, Antonio Olivas-Martinez, Andrea Rotnitzky, Peter B Gilbert

Abstract readReview
In one paragraph

Review in The Journal of infectious diseases, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Marco CaroneDepartment of Biostatistics, University of Washington, Seattle, Washington, USA.ORCID 0000-0003-2106-0953
Charles J WolockDepartment of Biostatistics, Epidemiology and Informatics, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
Antonio Olivas-MartinezDepartment of Biostatistics, University of Washington, Seattle, Washington, USA.
Andrea RotnitzkyDepartment of Biostatistics, University of Washington, Seattle, Washington, USA.
Peter B GilbertDepartment of Biostatistics, University of Washington, Seattle, Washington, USA.ORCID 0000-0002-2662-9427

Funding

SDMC: HIV Vaccine Trials NetworkUM1AI068635 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Peter B. Gilbert, Yunda Huang · 2011 to 2026
$385.9M
STATISTICAL ISSUES IN AIDS RESEARCHR37AI029168 · NIAID · UNIVERSITY OF WASHINGTON · PI JAMES P HUGHES · 1999 to 2026
$9.8M
Statistical Methods in HIV Vaccine Efficacy TrialsR37AI054165 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Peter B. Gilbert · 2010 to 2026
$6.7M
Statistical Methods for Incorporating Machine Learning Tools in Inference and Large-Scale Surveillance using Electronic Medical Records DataR01HL137808 · NHLBI · UNIVERSITY OF WASHINGTON · PI CARONE, MARCO · 2019 to 2023
$2.4M
NHLBI NIH HHS R01 HL137808NIAID NIH HHS R37 AI029168NIAID NIH HHS R37 AI054165NIAID NIH HHS UM1 AI068635NIH HHS
6 · The paper itself

Abstract

In immunobridging, an investigational vaccine is approved based on a randomized trial of this vaccine versus an approved vaccine with an immunogenicity primary endpoint. Justification for immunobridging requires demonstration that meeting trial success criteria implies the investigational vaccine provides worthwhile protection against a relevant endpoint for a context of use. We consider recent statistical approaches whose integration supports immunobridging: (1) variable importance prediction analysis characterizing immune markers as correlates of risk; (2) controlled risk causal analysis evaluating markers as correlates of protection; and (3) transportability analysis combining data from efficacy and immunobridging trials for estimating investigational versus approved relative-vaccine efficacy.

Indexed as

Immunogenicity, VaccineVaccine EfficacyVaccinesBiomarkersHumansRandomized Controlled Trials as TopicBiomarkersVaccinescontrolled riskcorrelates of protectiondata fusionrandomized controlled trialvariable importance analysis

Identifiers

PMID40971983
PMCPMC12494164

What OpenQuestion holds

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Registered trials

None linked

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.