Evidence map›Paper›PMID 36130187›Full record

ArticleClinical infectious diseases : an official publication of the Infectious Diseases Society of America2023

Associations of Immunogenicity and Reactogenicity After Severe Acute Respiratory Syndrome Coronavirus 2 mRNA-1273 Vaccine in the COVE and TeenCOVE Trials.

Uma Siangphoe, Lindsey R Baden, Hana M El Sahly, Brandon Essink, Kashif Ali, Gary Berman, Joanne E Tomassini, Weiping Deng, Rolando Pajon, Roderick McPhee and 5 more

Open access · bronzeAbstract read
In one paragraph

Article in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.6field-weighted citation impact, top 33% 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.

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

5 citing papers in PubMed, 6 citations in OpenAlex.

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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

15 authors at 5 institutions in 1 country.

Uma SiangphoeInfectious Disease Development, Moderna, Cambridge, Massachusetts, USA.ORCID 0000-0002-0560-6314
Lindsey R BadenDivision of Infectious Diseases, Brigham and Women's Hospital, Boston, Massachusetts, USA.
Hana M El SahlyMolecular Virology and Microbiology, Baylor College of Medicine, Houston, Texas, USA.
Brandon EssinkMeridian Clinical Research, Savannah, Georgia, USA.
Kashif AliKool Kids Pediatrics, DM Clinical Research, Houston, Texas, USA.
Gary BermanThe Clinical Research Institute, Minneapolis, Minnesota, USA.
Joanne E TomassiniInfectious Disease Development, Moderna, Cambridge, Massachusetts, USA.
Weiping DengInfectious Disease Development, Moderna, Cambridge, Massachusetts, USA.
Rolando PajonInfectious Disease Development, Moderna, Cambridge, Massachusetts, USA.
Roderick McPheeInfectious Disease Development, Moderna, Cambridge, Massachusetts, USA.
Avika DixitInfectious Disease Development, Moderna, Cambridge, Massachusetts, USA.
Rituparna DasInfectious Disease Development, Moderna, Cambridge, Massachusetts, USA.
Jacqueline M MillerInfectious Disease Development, Moderna, Cambridge, Massachusetts, USA.
Honghong ZhouInfectious Disease Development, Moderna, Cambridge, Massachusetts, USA.
COVE and TeenCOVE Study Groups
Moderna Therapeutics (United States) · USBaylor College of Medicine · USBrigham and Women's Hospital · USClinical Research Institute · USMeridian Clinical Research · 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
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
NCATS NIH HHS UL1 TR002384NIAID NIH HHS UM1 AI068614NIAID NIH HHS UM1 AI068618NIAID NIH HHS UM1 AI068619NIAID NIH HHS UM1 AI068635NIAID NIH HHS UM1 AI068636NIAID NIH HHS UM1 AI148684
6 · The paper itself

Abstract

backgroundThe reactogenicity and immunogenicity of coronavirus disease 2019 (COVID-19) vaccines are well studied. Little is known regarding the relationship between immunogenicity and reactogenicity of COVID-19 vaccines.

methodsThis study assessed the association between immunogenicity and reactogenicity after 2 mRNA-1273 (100 µg) injections in 1671 total adolescent and adult participants (≥12 years) from the primary immunogenicity sets of the blinded periods of the Coronavirus Efficacy (COVE) and TeenCOVE trials. Associations between immunogenicity through day 57 and solicited adverse reactions (ARs) after the first and second injections of mRNA-1273 were evaluated among participants with and without solicited ARs using linear mixed-effects models.

resultsmRNA-1273 reactogenicity in this combined analysis set was similar to that reported for these trials. The vaccine elicited high neutralizing antibody (nAb) geometric mean titers (GMTs) in evaluable participants. GMTs at day 57 were significantly higher in participants who experienced solicited systemic ARs after the second injection (1227.2 [1164.4-1293.5]) than those who did not (980.1 [886.8-1083.2], P = .001) and were associated with fever, chills, headache, fatigue, myalgia, and arthralgia. Significant associations with local ARs were not found.

conclusionsThese data show an association of systemic ARs with increased nAb titers following a second mRNA-1273 injection. While these data indicate systemic ARs are associated with increased antibody titers, high nAb titers were observed in participants after both injections, consistent with the immunogenicity and efficacy in these trials. These results add to the body of evidence regarding the relationship of immunogenicity and reactogenicity and can contribute toward the design of future mRNA vaccines.

Indexed as

COVID-19COVID-19 Vaccines2019-nCoV Vaccine mRNA-1273AdolescentAdultAntibodies, NeutralizingAntibodies, ViralHumansImmunogenicity, VaccineSARS-CoV-22019-nCoV Vaccine mRNA-1273Antibodies, NeutralizingAntibodies, ViralCOVID-19 VaccinesimmunogenicitymRNA-1273reactogenicitySARS-CoV-2solicited adverse reactions

Identifiers

PMID36130187
PMCPMC10202429
OpenAlexW4296907709

What OpenQuestion holds

Textmetadata
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Registered trials

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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.