Evidence map›Paper›PMID 41287255›Full record

ArticleThe Journal of infectious diseases2026

A Test-Negative Design for Immune Correlates Approximates a Traditional Exposure-Proximal Design but Requires Far Fewer Blood Samples.

Dean Follmann, Lauren Dang, Eric Chu, Jonathan Fintzi, Holly Janes, Peter B Gilbert, Leah I B Andrews, Leonid Serebryannyy, Robin Carroll, Bob Lin and 8 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in The Journal of infectious diseases, 2026. 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

18 authors.

Dean FollmannBiostatistics Research Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.ORCID 0000-0003-4073-0393
Lauren DangBiostatistics Research Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.
Eric ChuClinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick, Maryland, USA.
Jonathan FintziBiostatistics Research Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.
Holly JanesVaccine Infectious Disease and Public Health Sciences Divisions, Fred Hutchinson Cancer Center, Seattle, Washington, USA.
Peter B GilbertVaccine Infectious Disease and Public Health Sciences Divisions, Fred Hutchinson Cancer Center, Seattle, Washington, USA.ORCID 0000-0002-2662-9427
Leah I B AndrewsDepartment of Biostatistics, School of Public Health, University of Washington, Seattle, Washington, USA.ORCID 0000-0002-3418-9468
Leonid SerebryannyyVaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.
Robin CarrollVaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.
Bob LinVaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.
Richard KoupVaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.
Jon TomaResearch and Development Department, Monogram Biosciences, San Francisco, California, USA.
Weiping DengBiometrics Department, ModernaFP and ADClinical Development, Moderna, Cambridge, Massachusetts, USA.
Frances PriddyBiometrics Department, ModernaFP and ADClinical Development, Moderna, Cambridge, Massachusetts, USA.ORCID 0000-0002-2533-3982
Avika DixitBiometrics Department, ModernaFP and ADClinical Development, Moderna, Cambridge, Massachusetts, USA.
Honghong ZhouBiometrics Department, ModernaFP and ADClinical Development, Moderna, Cambridge, Massachusetts, USA.
Lindsey BadenDivision of Infectious Diseases, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts, USA.
Hana M El SahlyDepartments of Molecular Virology and Microbiology and Medicine, Baylor College of Medicine, Houston, Texas, USA.ORCID 0000-0003-0489-0074

Funding

WORK ORDER 126643 B539 EXPAND IC SUITE75N91019D00024 · NIAID · LEIDOS BIOMEDICAL RESEARCH, INC. · PI BRISCOE, LYNN · 2019 to 2025
$3932.6M
Biostatistics Research BranchIntramural Research ProgramNational Institute of Allergy and Infectious DiseasesNIH HHS 75N91019D00024NIH HHS HHSN261201500003IVaccine Research Center
6 · The paper itself

Abstract

Traditional vaccine clinical trials sample blood from all participants. In contrast, the test-negative immune correlates (TNIC) design only samples blood from participants who develop symptoms. We compared traditional to test-negative immune correlates methods in the mRNA-1273 severe acute respiratory syndrome coronavirus 2 vaccine efficacy clinical trial. Using a neutralizing antibody assay, hazard ratios were 0.48 (95% confidence interval [CI], .29-.73) and 0.55 (95% CI, .28-1.06) for traditional and test-negative methods, respectively. Analogous ratios for binding antibody assay were 0.69 (95% CI, .52-.94) and 0.78 (95% CI, .50-1.20). The results support use of the logistically simpler TNIC design.

Indexed as

Antibodies, NeutralizingAntibodies, ViralCOVID-19COVID-19 VaccinesSARS-CoV-2FemaleHumansMaleResearch DesignAntibodies, NeutralizingAntibodies, ViralCOVID-19 Vaccinescorrelates of protectioncorrelates of risktest-negative designvaccines

Identifiers

PMID41287255
PMCPMC13017828

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.