Evidence map›Paper›PMID 37330602›Full record

Trial reportNature communications2023

Examining protective effects of SARS-CoV-2 neutralizing antibodies after vaccination or monoclonal antibody administration.

Dean Follmann, Meagan P O'Brien, Jonathan Fintzi, Michael P Fay, David Montefiori, Allyson Mateja, Gary A Herman, Andrea T Hooper, Kenneth C Turner, Kuo- Chen Chan and 14 more

Registry-linked trialAbstract readClinical Trial
In one paragraph

Trial report in Nature communications, 2023. 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 33 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
33citing papers in PubMed, 1 pooled it
–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

33 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
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  11. Extending ImmunoSpotVaccines · 2026
    Article
  12. Exposure proximal immune correlates analysis.Biostatistics (Oxford, England) · 2025
    Article
  13. Review
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  15. Article
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  18. Review
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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

24 authors.

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
Meagan P O'BrienRegeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.
Jonathan FintziBiostatistics Research Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
Michael P FayBiostatistics Research Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.ORCID 0000-0002-8643-9625
David MontefioriDepartment of Surgery, Duke University Medical Center, Durham, NC, USA.
Allyson MatejaClinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick, MD, USA.
Gary A HermanRegeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.
Andrea T HooperRegeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.
Kenneth C TurnerRegeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.
Kuo- Chen ChanRegeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.ORCID 0000-0002-3341-8783
Eduardo Forleo-NetoRegeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.ORCID 0000-0003-1959-8156
Flonza IsaRegeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.
Lindsey R BadenBrigham and Women's Hospital, Boston, MA, USA.
Hana M El SahlyDepartment of Molecular Virology and Microbiology, Baylor College of Medicine, Houston, TX, USA.
Holly JanesVaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
Nicole Doria-RoseVaccine Research Center, National Institutes of Health, Bethesda, MD, USA.ORCID 0000-0002-5731-3054
Jacqueline MillerModerna, Inc., Cambridge, MA, USA.
Honghong ZhouModerna, Inc., Cambridge, MA, USA.
Weiping DangModerna, Inc., Cambridge, MA, USA.
David BenkeserDepartment of Biostatistics and Bioinformatics, Rollins School of Public Health, Emory University, Atlanta, GA, USA.ORCID 0000-0002-1019-8343
Youyi FongVaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
Peter B GilbertVaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
Mary MarovichBiostatistics Research Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
Myron S CohenInstitute for Global Health and Infectious Diseases, The University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.

Funding

WORK ORDER 126643 B539 EXPAND IC SUITE75N91019D00024 · NIAID · LEIDOS BIOMEDICAL RESEARCH, INC. · PI BRISCOE, LYNN · 2019 to 2025
$3932.6M
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 the Infectious Diseases Clinical Research Consortium (IDCRCLG) - Momi-Vax DMID #21-0004 {Supplement #6}UM1AI148684 · NIAID · EMORY UNIVERSITY · PI DAVID S STEPHENS · 2020 to 2026
$77.2M
Vaccine and Treatment Evaluation Units (VTEU)-DMID 21-0004UM1AI148575 · NIAID · BAYLOR COLLEGE OF MEDICINE · PI HANA M EL SAHLY · 2020 to 2026
$29.4M
Quantitative Immunological Assays to Assess SARS-CoV-2 Antibodies and VaccinesZICAI005169 · NIAID · NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES · PI DORIA-ROSE, NICOLE · 2023 to 2025
$2.1M
NCI NIH HHS 75N91019D00024NIAID NIH HHS UM1 AI068635NIAID NIH HHS UM1 AI148575NIAID NIH HHS UM1 AI148684
6 · The paper itself

Abstract

While new vaccines for SARS-CoV-2 are authorized based on neutralizing antibody (nAb) titer against emerging variants of concern, an analogous pathway does not exist for preventative monoclonal antibodies. In this work, nAb titers were assessed as correlates of protection against COVID-19 in the casirivimab + imdevimab monoclonal antibody (mAb) prevention trial (ClinicalTrials.gov #NCT4452318) and in the mRNA-1273 vaccine trial (ClinicalTrials.gov #NCT04470427). In the mAb trial, protective efficacy of 92% (95% confidence interval (CI): 84%, 98%) is associated with a nAb titer of 1000 IU50/ml, with lower efficacy at lower nAb titers. In the vaccine trial, protective efficacies of 93% [95% CI: 91%, 95%] and 97% (95% CI: 95%, 98%) are associated with nAb titers of 100 and 1000 IU50/ml, respectively. These data quantitate a nAb titer correlate of protection for mAbs benchmarked alongside vaccine induced nAb titers and support nAb titer as a surrogate endpoint for authorizing new mAbs.

Indexed as

Antibodies, MonoclonalCOVID-192019-nCoV Vaccine mRNA-1273Antibodies, NeutralizingAntibodies, ViralCOVID-19 VaccinesHumansSARS-CoV-2Vaccination2019-nCoV Vaccine mRNA-1273Antibodies, MonoclonalAntibodies, NeutralizingAntibodies, ViralCOVID-19 Vaccines

Identifiers

PMID37330602
PMCPMC10276829

What OpenQuestion holds

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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.