Evidence map›Paper›PMID 33707061›Full record

Trial reportVaccine2021

A preliminary report of a randomized controlled phase 2 trial of the safety and immunogenicity of mRNA-1273 SARS-CoV-2 vaccine.

Laurence Chu, Roderick McPhee, Wenmei Huang, Hamilton Bennett, Rolando Pajon, Biliana Nestorova, Brett Leav, mRNA-1273 Study Group

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Vaccine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04405076 (A Phase 2a, Randomized, Observer-Blind, Placebo Controlled, Dose-Confirmation Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1273 SARS-COV-2 Vaccine in Adults Aged 18 Years and Older), which is not on this map. Cited by 137 papers, 16 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
137citing papers in PubMed, 16 pooled it
13.9field-weighted citation impact, top 1% 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.

NCT04405076 phase2completednot on this map

A Phase 2a, Randomized, Observer-Blind, Placebo Controlled, Dose-Confirmation Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1273 SARS-COV-2 Vaccine in Adults Aged 18 Years and Older

TypeinterventionalSponsorModernaTX, Inc.Ran2020 to 2021Enrolled660ConditionsSARS-CoV-2ArmsBiological: mRNA-1273, Placebo, mRNA-1273.351
3 · Its place in the literature

Who cites it

137 citing papers in PubMed, 16 syntheses or guidelines pooled it, 231 citations in OpenAlex.

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  4. Efficacy and safety of COVID-19 vaccines.The Cochrane database of systematic reviews · 2022
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  10. Immunogenicity and Safety of the COVID-19 Vaccines Compared With Control in Healthy Adults: A Qualitative and Systematic Review.Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research · 2022
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77 more citing papers are in PubMed but not listed here.

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

8 authors at 2 institutions in 1 country.

Laurence ChuBenchmark Research, 3100 Red River St #2, Austin, TX 78705, United States.
Roderick McPheeModerna, Inc., 200 Technology Sq, Cambridge, MA 02139, United States.
Wenmei HuangModerna, Inc., 200 Technology Sq, Cambridge, MA 02139, United States.
Hamilton BennettModerna, Inc., 200 Technology Sq, Cambridge, MA 02139, United States.
Rolando PajonModerna, Inc., 200 Technology Sq, Cambridge, MA 02139, United States.
Biliana NestorovaModerna, Inc., 200 Technology Sq, Cambridge, MA 02139, United States.
Brett LeavModerna, Inc., 200 Technology Sq, Cambridge, MA 02139, United States. Electronic address: brett.leav@modernatx.com.
mRNA-1273 Study Group
Moderna Therapeutics (United States) · USBenchmark Research (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundVaccines are urgently needed to prevent the global spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). We assessed the safety and immunogenicity of vaccine candidate mRNA-1273, encoding the prefusion-stabilized spike protein of SARS-CoV-2.

methodsThis phase 2, randomized, observer-blind, placebo-controlled trial was conducted at 8 sites in the USA, in healthy adults aged ≥18 years with no known history or risk of SARS-CoV-2 infection, and had not previously received an investigational CoV vaccine or treatment. Participants were stratified into two age cohorts (≥18-<55 and ≥55) and were randomly assigned (1:1:1) to either 50 or 100 µg of mRNA-1273, or placebo administered as two intramuscular injections 28 days apart. The primary outcomes were safety, reactogenicity, and immunogenicity assessed by anti-SARS-CoV-2-spike binding antibody level (bAb). Secondary outcome was immunogenicity assessed by SARS-CoV-2 neutralizing antibody (nAb) response.

resultsBetween 29 May and 8 July 2020, 600 participants were randomized, 300 per age cohort. The most common solicited adverse reactions were pain at injection site, headache, and fatigue following each vaccination in both age cohorts. One serious adverse event deemed unrelated by the site investigator occurred 33 days post-vaccination one. mRNA-1273 induced bAb and nAb by 28 days post-vaccination one that were higher at the 100 µg dose relative to the 50 µg dose; this difference was less apparent post-vaccination two. Binding antibodies and nAb increased substantially by 14 days following the second vaccination (day 43) to levels exceeding those of convalescent sera and remained elevated through day 57.

conclusionsVaccination with mRNA-1273 resulted in significant immune responses to SARS-CoV-2 in participants 18 years and older, with an acceptable safety profile, confirming the safety and immunogenicity of 50 and 100 µg mRNA-1273 given as a 2 dose-regimen. ClinicalTrials.gov; NCT04405076.

Indexed as

COVID-19VaccinesAdolescentAdultAntibodies, ViralCOVID-19 SerotherapyCOVID-19 VaccinesDouble-Blind MethodHumansImmunization, PassiveImmunogenicity, VaccineRNA, MessengerSARS-CoV-2Antibodies, ViralCOVID-19 VaccinesRNA, MessengerVaccinesCOVID-19ImmunogenicitymRNA-1273Phase 2SafetySARS-CoV-2Vaccine

Identifiers

PMID33707061
PMCPMC7871769
OpenAlexW3128853581

What OpenQuestion holds

Textmetadata
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.