Evidence map›Paper›PMID 39792478›Full record

Trial reportThe Journal of infectious diseases2025

Safety and Immunogenicity of SARS-CoV-2 Spike Receptor-Binding Domain and N-Terminal Domain mRNA Vaccine.

Spyros Chalkias, Antionette Pragalos, Adebayo Akinsola, Gary Berman, Madhavi Ampajwala, Jay Meyer, Lorraine Schoch, Wen Zhou, Yamuna D Paila, Weiping Deng and 5 more

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

Trial report in The Journal of infectious diseases, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05137236 (A Phase 2A, Randomized, Stratified, Observer-Blind Study to Evaluate the Immunogenicity and Safety of mRNA-1283 Vaccine Boosters for SARS-CoV-2), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing 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.

NCT05137236 phase2completednot on this map

A Phase 2A, Randomized, Stratified, Observer-Blind Study to Evaluate the Immunogenicity and Safety of mRNA-1283 Vaccine Boosters for SARS-CoV-2

TypeinterventionalSponsorModernaTX, Inc.Ran2021 to 2023Enrolled540ConditionsSARS-CoV-2ArmsmRNA-1283, mRNA-1283.211, mRNA-1273, mRNA-1283.529
3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Trial
  2. Review
  3. Article
  4. Article
  5. Review
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.

Spyros ChalkiasClinical Development, Infectious Diseases, Moderna, Inc, Cambridge, Massachusetts, USA.ORCID 0000-0002-6254-1158
Antionette PragalosCTI Clinical Trial and Consulting Services, Covington, Kentucky, USA.
Adebayo AkinsolaTekton Research, Atlanta, Georgia, USA.
Gary BermanClinical Research Institute, Inc, Minneapolis, Minnesota, USA.
Madhavi AmpajwalaAdvanced Care Research Centers (ACRC) Trials, Plano, Texas, USA.
Jay MeyerVelocity Clinical Research, Lincoln, Nebraska, USA.
Lorraine SchochClinical Operations, Infectious Disease, Moderna, Inc, Cambridge, Massachusetts, USA.
Wen ZhouBiostatistics, Moderna, Inc, Cambridge, Massachusetts, USA.
Yamuna D PailaClinical Biomarkers, Infectious Disease, Moderna, Inc, Cambridge, Massachusetts, USA.
Weiping DengBiostatistics, Moderna, Inc, Cambridge, Massachusetts, USA.
Jing FengBiostatistics, Moderna, Inc, Cambridge, Massachusetts, USA.
Elizabeth de WindtClinical Safety, Moderna, Inc, Cambridge, Massachusetts, USA.
Darin EdwardsInfectious Disease, Moderna, Inc, Cambridge, Massachusetts, USA.
Jacqueline MillerResearch and Development, Infectious Disease, Moderna, Inc, Cambridge, Massachusetts, USA.
Rituparna DasResearch and Development, Infectious Disease, Moderna, Inc, Cambridge, Massachusetts, USA.

Funding

Moderna, Inc
6 · The paper itself

Abstract

backgroundmRNA-1283 is an investigational coronavirus disease 2019 (COVID-19) mRNA vaccine encoding the receptor-binding and N-terminal domains of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein in contrast to the original mRNA-1273 vaccine, which encodes the full-length spike protein.

methodsA phase 2a, dose-ranging, observer-blind, randomized study conducted in adults (aged ≥18 years) previously vaccinated with mRNA-1273 evaluated the safety and immunogenicity of a single dose of mRNA-1283 (2.5, 5, and 10 µg) and its bivalent formulation, mRNA-1283.211 (5 and 10 µg; encoding original SARS-CoV-2 and Beta) against the comparator mRNA-1273 vaccine, 50 µg (part A). A subsequent, open-label study (part B) evaluated the safety and immunogenicity of a monovalent Omicron BA.1 vaccine, mRNA-1283.529 (5 and 10 µg).

resultsA total of 340 participants were randomized in part A, and 200 participants were enrolled in part B. All dose levels of mRNA-1283 vaccines were well tolerated and increased the neutralizing antibody (nAb) responses at day 29 compared to baseline against SARS-CoV-2 D614G and Beta. The nAb responses elicited by mRNA-1283 were higher than those elicited by mRNA-1273. mRNA-1283.529 (part B) increased nAb at day 29 against Omicron BA.1. Antibody responses remained detectable for a year postvaccination.

conclusionsmRNA-1283 was well tolerated and exhibited improved immunogenicity compared to mRNA-1273. CLINICAL TRIALS REGISTRATION: NCT05137236.

Indexed as

COVID-19COVID-19 VaccinesImmunogenicity, VaccineSARS-CoV-2Spike Glycoprotein, Coronavirus2019-nCoV Vaccine mRNA-1273AdolescentAdultAgedAntibodies, NeutralizingAntibodies, ViralFemaleHumansMaleMiddle AgedmRNA Vaccines2019-nCoV Vaccine mRNA-1273Antibodies, NeutralizingAntibodies, ViralCOVID-19 VaccinesmRNA VaccinesSpike Glycoprotein, Coronavirusspike protein, SARS-CoV-2Vaccines, Syntheticbooster vaccinationclinical studyCOVID-19mRNA-1273mRNA-1283mRNA vaccinesSARS-CoV-2

Identifiers

PMID39792478
PMCPMC11998576

What OpenQuestion holds

Textmetadata
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.