Evidence map›Paper›PMID 39261482›Full record

Trial reportNature communications2024

Omicron COVID-19 immune correlates analysis of a third dose of mRNA-1273 in the COVE trial.

Bo Zhang, Youyi Fong, Jonathan Fintzi, Eric Chu, Holly E Janes, Avi Kenny, Marco Carone, David Benkeser, Lars W P van der Laan, Weiping Deng and 33 more

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase III
In one paragraph

Trial report in Nature communications, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04470427 (A Phase 3, Randomized, Stratified, Observer-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1273 SARS-CoV-2 Vaccine in Adults Aged 18 Years and Older), which is not on this map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing 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.

NCT04470427 phase3completednot on this map

A Phase 3, Randomized, Stratified, Observer-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1273 SARS-CoV-2 Vaccine in Adults Aged 18 Years and Older

TypeinterventionalSponsorModernaTX, Inc.Ran2020 to 2022Enrolled30,415ConditionsSARS-CoV-2ArmsmRNA-1273, Placebo
3 · Its place in the literature

Who cites it

13 citing papers in PubMed.

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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

43 authors.

Bo ZhangVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.ORCID 0000-0002-4381-1124
Youyi FongVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.
Jonathan FintziBiostatistics Research Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
Eric ChuClinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick, MD, USA.
Holly E JanesVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.
Avi KennyDepartment of Biostatistics, University of Washington, Seattle, WA, USA.
Marco CaroneDepartment of Biostatistics, University of Washington, Seattle, WA, USA.ORCID 0000-0003-2106-0953
David BenkeserDepartment of Biostatistics and Bioinformatics, Rollins School of Public Health, Emory University, Atlanta, GA, USA.ORCID 0000-0002-1019-8343
Lars W P van der LaanDepartment of Statistics, University of Washington, Seattle, WA, USA.
Weiping DengModerna, Inc, Cambridge, MA, USA.
Honghong ZhouModerna, Inc, Cambridge, MA, USA.
Xiaowei WangModerna, Inc, Cambridge, MA, USA.
Yiwen LuVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.
Chenchen YuVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.
Bhavesh BorateVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.
Haiyan ChenBiomedical Advanced Research and Development Authority, Washington, DC, USA.
Isabel ReederBiomedical Advanced Research and Development Authority, Washington, DC, USA.ORCID 0009-0009-0374-6768
Lindsay N CarppVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.ORCID 0000-0003-0333-5925
Christopher R HouchensBiomedical Advanced Research and Development Authority, Washington, DC, USA.
Karen MartinsBiomedical Advanced Research and Development Authority, Washington, DC, USA.
Lakshmi JayashankarBiomedical Advanced Research and Development Authority, Washington, DC, USA.
Chuong HuynhBiomedical Advanced Research and Development Authority, Washington, DC, USA.
Carl J FichtenbaumDivision of Infectious Diseases, Department of Medicine, University of Cincinnati, Cincinnati, OH, USA.ORCID 0000-0002-6778-7253
Spyros KalamsDepartment of Pathology, Microbiology and Immunology, Vanderbilt University Medical Center, Nashville, TN, USA.ORCID 0000-0003-0098-7995
Cynthia L GayDepartment of Medicine, Division of Infectious Diseases, UNC HIV Cure Center, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, NC, USA.ORCID 0000-0002-3620-3059
Michele P AndrasikVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.
James G KublinVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.
Lawrence CoreyVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.ORCID 0000-0002-2179-2436
Kathleen M NeuzilCenter for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, MD, USA.ORCID 0000-0001-9480-2714
Frances PriddyModerna, Inc, Cambridge, MA, USA.
Rituparna DasModerna, Inc, Cambridge, MA, USA.
Bethany GirardModerna, Inc, Cambridge, MA, USA.
Hana M El SahlyDepartment of Molecular Virology and Microbiology, Baylor College of Medicine, Houston, TX, USA.ORCID 0000-0003-0489-0074
Lindsey R BadenBrigham and Women's Hospital, Boston, MA, USA.ORCID 0009-0004-1752-1926
Thomas JonesBiomedical Advanced Research and Development Authority, Washington, DC, USA.
Ruben O DonisBiomedical Advanced Research and Development Authority, Washington, DC, USA.ORCID 0000-0001-6137-8312
Richard A KoupVaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
Peter B GilbertVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.ORCID 0000-0002-2662-9427
Dean FollmannBiostatistics Research Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA. dfollmann@niaid.nih.gov.ORCID 0000-0003-4073-0393
United States Government (USG) COVID-19 Immune Assays Team
Moderna, Inc. Team
Coronavirus Vaccine Prevention Network (CoVPN)/Coronavirus Efficacy (COVE) Team
USG/CoVPN Biostatistics Team

Funding

WORK ORDER 126643 B539 EXPAND IC SUITE75N91019D00024 · NIAID · LEIDOS BIOMEDICAL RESEARCH, INC. · PI BRISCOE, LYNN · 2019 to 2025
$3932.6M
LOC: HIV Vaccine Trials NetworkUM1AI068614 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Dan H. Barouch, Lawrence Corey · 2011 to 2026
$1175.6M
SDMC: HIV Vaccine Trials NetworkUM1AI068635 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Peter B. Gilbert, Yunda Huang · 2011 to 2026
$385.9M
Leadership Group for a Global HIV Vaccine Clinical Trials NetworkU01AI068614 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI COREY, LAWRENCE · 2006 to 2010
$181.5M
Vaccine and Treatment Evaluation Units (VTEU)-DMID 21-0004UM1AI148575 · NIAID · BAYLOR COLLEGE OF MEDICINE · PI HANA M EL SAHLY · 2020 to 2026
$29.4M
Statistical Methods in HIV Vaccine Efficacy TrialsR37AI054165 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Peter B. Gilbert · 2010 to 2026
$6.7M
NCI NIH HHS 75N91019D00024NIAID NIH HHS R37 AI054165NIAID NIH HHS U01 AI068614NIAID NIH HHS UM1 AI068614NIAID NIH HHS UM1 AI068635NIAID NIH HHS UM1 AI148575
6 · The paper itself

Abstract

In the phase 3 Coronavirus Efficacy (COVE) trial (NCT04470427), post-dose two Ancestral Spike-specific binding (bAb) and neutralizing (nAb) antibodies were shown to be correlates of risk (CoR) and of protection against Ancestral-lineage COVID-19 in SARS-CoV-2 naive participants. In the SARS-CoV-2 Omicron era, Omicron subvariants with varying degrees of immune escape now dominate, seropositivity rates are high, and booster doses are administered, raising questions on whether and how these developments affect the bAb and nAb correlates. To address these questions, we assess post-boost BA.1 Spike-specific bAbs and nAbs as CoRs and as correlates of booster efficacy in COVE. For naive individuals, bAbs and nAbs inversely correlate with Omicron COVID-19: hazard ratios (HR) per 10-fold marker increase (95% confidence interval) are 0.16 (0.03, 0.79) and 0.31 (0.10, 0.96), respectively. In non-naive individuals the analogous results are similar: 0.15 (0.04, 0.63) and 0.28 (0.07, 1.08). For naive individuals, three vs two-dose booster efficacy correlates with predicted nAb titer at exposure, with estimates -8% (-126%, 48%), 50% (25%, 67%), and 74% (49%, 87%), at 56, 251, and 891 Arbitrary Units/ml. These results support the continued use of antibody as a surrogate endpoint.

Indexed as

2019-nCoV Vaccine mRNA-1273Antibodies, NeutralizingAntibodies, ViralCOVID-19Immunization, SecondarySARS-CoV-2Spike Glycoprotein, CoronavirusAdultCOVID-19 VaccinesFemaleHumansMaleVaccine Efficacy2019-nCoV Vaccine mRNA-1273Antibodies, NeutralizingAntibodies, ViralCOVID-19 VaccinesSpike Glycoprotein, Coronavirusspike protein, SARS-CoV-2

Identifiers

PMID39261482
PMCPMC11390939

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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.