Trial reportInternational journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases2023
Stochastic interventional approach to assessing immune correlates of protection: Application to the COVE messenger RNA-1273 vaccine trial.
Trial report in International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.
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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.
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Who cites it
11 citing papers in PubMed, 13 citations in OpenAlex.
- Immune correlates analysis in NextCOVE trial for a next-generation mRNA-1283 COVID-19 vaccine.Human vaccines & immunotherapeutics · 2026Trial
- Neutralizing antibody immune correlates in COVAIL trial recipients of an mRNA second COVID-19 vaccine boost.Nature communications · 2025Trial
- Neutralizing antibody correlate of protection against severe-critical COVID-19 in the ENSEMBLE single-dose Ad26.COV2.S vaccine efficacy trial.Nature communications · 2024Trial
- Omicron COVID-19 immune correlates analysis of a third dose of mRNA-1273 in the COVE trial.Nature communications · 2024Trial
- Long-term safety and effectiveness of mRNA-1273 vaccine in adults: COVE trial open-label and booster phases.Nature communications · 2024Trial
- Correlates of severe and delta COVID-19 in a phase 3 trial of the AZD1222 vaccine.NPJ vaccines · 2026Article
- Article
- Immune correlates analysis of antibody responses against SARS-CoV-2 variants in the ENSEMBLE vaccine efficacy trial.iScience · 2025Article
- Neutralizing and binding antibodies are a correlate of risk of COVID-19 in the CoVPN 3008 study in people with HIV.Nature communications · 2025Article
- Replicated blood-based biomarkers for myalgic encephalomyelitis not explicable by inactivity.EMBO molecular medicine · 2025Article
- Review
Corrections and comments
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Authors and funding
13 authors at 9 institutions in 1 country.
Funding
Abstract
backgroundStochastic interventional vaccine efficacy (SVE) analysis is a new approach to correlate of protection (CoP) analysis of a phase III trial that estimates how vaccine efficacy (VE) would change under hypothetical shifts of an immune marker.
methodsWe applied nonparametric SVE methodology to the COVE trial of messenger RNA-1273 vs placebo to evaluate post-dose 2 pseudovirus neutralizing antibody (nAb) titer against the D614G strain as a CoP against COVID-19. Secondly, we evaluated the ability of these results to predict VE against variants based on shifts of geometric mean titers to variants vs D614G. Prediction accuracy was evaluated by 13 validation studies, including 12 test-negative designs.
resultsSVE analysis of COVE supported post-dose 2 D614G titer as a CoP: estimated VE ranged from 66.9% (95% confidence interval: 36.2, 82.8%) to 99.3% (99.1, 99.4%) at 10-fold decreased or increased titer shifts, respectively. The SVE estimates only weakly predicted variant-specific VE estimates (concordance correlation coefficient 0.062 for post 2-dose VE).
conclusionSVE analysis of COVE supports nAb titer as a CoP for messenger RNA vaccines. Predicting variant-specific VE proved difficult due to many limitations. Greater anti-Omicron titers may be needed for high-level protection against Omicron vs anti-D614G titers needed for high-level protection against pre-Omicron COVID-19.
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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.