Evidence map›Paper›PMID 35145311›Full record

Trial reportNature medicine2022

Initial analysis of viral dynamics and circulating viral variants during the mRNA-1273 Phase 3 COVE trial.

Rolando Pajon, Yamuna D Paila, Bethany Girard, Groves Dixon, Katherine Kacena, Lindsey R Baden, Hana M El Sahly, Brandon Essink, Kathleen M Mullane, Ian Frank and 10 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase III
In one paragraph

Trial report in Nature medicine, 2022. 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 29 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed, 2 pooled it
3.5field-weighted citation impact, top 6% of its field
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

29 citing papers in PubMed, 2 syntheses or guidelines pooled it, 35 citations in OpenAlex.

  1. Assessing the robustness of COVID-19 vaccine efficacy trials: systematic review and meta-analysis, January 2023.Euro surveillance : bulletin Europeen sur les maladies transmissibles = European communicable disease bulletin · 2023
    Pooled it
  2. Efficacy and safety of COVID-19 vaccines.The Cochrane database of systematic reviews · 2022
    Pooled it
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  7. Stochastic interventional approach to assessing immune correlates of protection: Application to the COVE messenger RNA-1273 vaccine trial.International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases · 2023
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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

20 authors at 8 institutions in 1 country.

Rolando PajonModerna, Inc., Cambridge, MA, USA. rolando.pajon@modernatx.com.ORCID http://orcid.org/0000-0002-5155-5079
Yamuna D PailaModerna, Inc., Cambridge, MA, USA.
Bethany GirardModerna, Inc., Cambridge, MA, USA.
Groves DixonModerna, Inc., Cambridge, MA, USA.
Katherine KacenaModerna, Inc., Cambridge, MA, USA.
Lindsey R BadenBrigham and Women's Hospital, Boston, MA, USA.
Hana M El SahlyBaylor College of Medicine, Houston, TX, USA.
Brandon EssinkMeridian Clinical Research, Omaha, NE, USA.
Kathleen M MullaneUniversity of Chicago, Chicago, IL, USA.
Ian FrankUniversity of Pennsylvania, Philadelphia, PA, USA.
Douglas DenhanClinical Trials of Texas, San Antonio, TX, USA.
Edward KerwinCriscor Clinical Research Institute, Medford, OR, USA.ORCID http://orcid.org/0000-0002-1697-9036
Xiaoping ZhaoModerna, Inc., Cambridge, MA, USA.
Baoyu DingModerna, Inc., Cambridge, MA, USA.
Weiping DengModerna, Inc., Cambridge, MA, USA.
Joanne E TomassiniModerna, Inc., Cambridge, MA, USA.ORCID http://orcid.org/0000-0002-9399-2867
Honghong ZhouModerna, Inc., Cambridge, MA, USA.
Brett LeavModerna, Inc., Cambridge, MA, USA.
Florian SchödelModerna, Inc., Cambridge, MA, USA.
COVE Trial Consortium
Moderna Therapeutics (United States) · USBaylor College of Medicine · USBrigham and Women's Hospital · USClinical Research Institute · USClinical Trials of Texas · USMeridian Clinical Research · USUniversity of Illinois Chicago · USUniversity of Pennsylvania · US

Funding

LOC: HIV Vaccine Trials NetworkUM1AI068614 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Dan H. Barouch, Lawrence Corey · 2011 to 2026
$1175.6M
Leadership and Operations Center (LOC), AIDS Clinical Trials Group (ACTG); LOC 1/UM1AI068636 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Joseph J Eron, RAJESH T GANDHI · 2011 to 2026
$1073.1M
LOC: HIV Prevention Trials NetworkUM1AI068619 · NIAID · FAMILY HEALTH INTERNATIONAL · PI Sinead Delany-Moretlwe, RAPHAEL J LANDOVITZ · 2011 to 2026
$779.5M
LC: HIV Vaccine Trials NetworkUM1AI068618 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Margaret Juliana McElrath · 2011 to 2026
$483.6M
SDMC: HIV Vaccine Trials NetworkUM1AI068635 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Peter B. Gilbert, Yunda Huang · 2011 to 2026
$385.9M
Disparities in COVID Disease Severity and Outcomes in New York CityUL1TR002384 · NCATS · WEILL MEDICAL COLL OF CORNELL UNIV · PI JULIANNE L IMPERATO-MCGINLEY · 2017 to 2026
$86.2M
Virus & Reservoirs CoreP30AI045008 · NIAID · UNIVERSITY OF PENNSYLVANIA · PI DAVID S METZGER · 1999 to 2026
$78.6M
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
Harvard Medical School Vaccine Clinical Trials UnitUM1AI069412 · NIAID · BRIGHAM AND WOMEN'S HOSPITAL · PI Lindsey Robert Baden, Daniel R. Kuritzkes · 2012 to 2026
$57.2M
University of Pennsylvania HIV Clinical Trials UnitUM1AI069534 · NIAID · UNIVERSITY OF PENNSYLVANIA · PI Ian Frank, PABLO TEBAS · 2012 to 2026
$33.0M
Vaccine and Treatment Evaluation Units (VTEU)-DMID 21-0004UM1AI148575 · NIAID · BAYLOR COLLEGE OF MEDICINE · PI HANA M EL SAHLY · 2020 to 2026
$29.4M
NCATS NIH HHS UL1 TR002384NIAID NIH HHS P30 AI045008NIAID NIH HHS UM1 AI068614NIAID NIH HHS UM1 AI068618NIAID NIH HHS UM1 AI068619NIAID NIH HHS UM1 AI068635NIAID NIH HHS UM1 AI068636NIAID NIH HHS UM1 AI069412NIAID NIH HHS UM1 AI069534NIAID NIH HHS UM1 AI148575NIAID NIH HHS UM1 AI148684
6 · The paper itself

Abstract

The mRNA-1273 vaccine for coronavirus disease 2019 (COVID-19) demonstrated 93.2% efficacy in reduction of symptomatic severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections in the blinded portion of the Phase 3 Coronavirus Efficacy (COVE) trial. While mRNA-1273 demonstrated high efficacy in prevention of COVID-19, including severe disease, its effect on the viral dynamics of SARS-CoV-2 infections is not understood. Here, in exploratory analyses, we assessed the impact of mRNA-1273 vaccination in the ongoing COVE trial (number NCT04470427) on SARS-CoV-2 copy number and shedding, burden of disease and infection, and viral variants. Viral variants were sequenced in all COVID-19 and adjudicated COVID-19 cases (n = 832), from July 2020 in the blinded part A of the study to May 2021 of the open-label part B of the study, in which participants in the placebo arm started to receive the mRNA-1273 vaccine after US Food and Drug Administration emergency use authorization of mRNA-1273 in December 2020. mRNA-1273 vaccination significantly reduced SARS-CoV-2 viral copy number (95% confidence interval) by 100-fold on the day of diagnosis compared with placebo (4.1 (3.4-4.8) versus 6.2 (6.0-6.4) log

Indexed as

COVID-19SARS-CoV-22019-nCoV Vaccine mRNA-1273HumansUnited States2019-nCoV Vaccine mRNA-1273

Identifiers

PMID35145311
PMCPMC9018421
OpenAlexW4225259281

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

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.