Evidence map›Paper›PMID 40102593›Full record

Trial reportNature medicine2025

mRNA-based seasonal influenza and SARS-CoV-2 multicomponent vaccine in healthy adults: a phase 1/2 trial.

Amanda K Rudman Spergel, Jintanat Ananworanich, Ruiting Guo, Weiping Deng, Lizbeth Carmona, Kristin Schaefers, Yamuna D Paila, Boris Kandinov, Charles H Eger, Melissa Sinkiewicz and 3 more

Registry-linked trialAbstract readClinical Trial, Phase IIClinical Trial, Phase IRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Nature medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05827926 (A Phase 1/2, Randomized, Observer-blind, Active-Control Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-based Influenza and SARS-CoV-2 Multi-component Vaccines in Healthy Adults), which is not on this map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing 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.

NCT05827926 phase1 / phase2completednot on this map

A Phase 1/2, Randomized, Observer-blind, Active-Control Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-based Influenza and SARS-CoV-2 Multi-component Vaccines in Healthy Adults

TypeinterventionalSponsorModernaTX, Inc.Ran2023 to 2024Enrolled1,758ConditionsSARS-CoV-2, InfluenzaArmsInfluenza Vaccine 1, mRNA-1083.1, mRNA-1083.2, mRNA-1083.3, Investigational Influenza Vaccine 1
3 · Its place in the literature

Who cites it

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

  1. Pooled it
  2. Trial
  3. Trial
  4. Article
  5. Article
  6. Review
  7. Review
  8. Review
  9. Article
  10. Article
  11. 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

13 authors.

Amanda K Rudman SpergelModerna Inc., Cambridge, MA, USA.
Jintanat AnanworanichModerna Inc., Cambridge, MA, USA.
Ruiting GuoModerna Inc., Cambridge, MA, USA.
Weiping DengModerna Inc., Cambridge, MA, USA.
Lizbeth CarmonaModerna Biopharma Canada Corporation, Toronto, Ontario, Canada.
Kristin SchaefersModerna Inc., Cambridge, MA, USA.
Yamuna D PailaModerna Inc., Cambridge, MA, USA.
Boris KandinovModerna Inc., Cambridge, MA, USA.
Charles H EgerVelocity Clinical Research Inc., Cincinnati, OH, USA.
Melissa SinkiewiczModerna Inc., Cambridge, MA, USA.
Sarah ShaoModerna Inc., Cambridge, MA, USA.
Carole HenryModerna Inc., Cambridge, MA, USA.
Christine A ShawModerna Inc., Cambridge, MA, USA. christine.shaw@modernatx.com.ORCID http://orcid.org/0000-0002-0471-206X

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

A multicomponent vaccine targeting several seasonal respiratory pathogens may provide simultaneous protection in a single-injection regimen. We present interim (28 days) findings from a phase 1/2 study of an mRNA-based multicomponent vaccine (mRNA-1083), encoding seasonal influenza and SARS-CoV-2 antigens. Adults (18-79 years) were randomly assigned to receive different compositions of mRNA-1083 at varying dose levels on day 1. The primary study objectives were reactogenicity through 7 days and safety through 28 days postvaccination, and the secondary study objective was immunogenicity against vaccine-matched influenza and SARS-CoV-2 strains at day 29 assessed by hemagglutination inhibition and pseudovirus neutralization assays, respectively. The multicomponent mRNA-1083 vaccine was generally well-tolerated, with most solicited adverse reactions being Grade 1 or 2 in severity. The incidence of unsolicited adverse events was similar across vaccine groups. mRNA-1083 induced immune responses against influenza and SARS-CoV-2 that were, in general, similar to or higher than those achieved with licensed quadrivalent influenza (standard or high dose) and SARS-CoV-2 (bivalent mRNA-1273) vaccines. These data support ongoing phase 3 evaluation of the mRNA-1083 vaccine. ClinicalTrials.gov registration: NCT05827926 .

Indexed as

COVID-19COVID-19 VaccinesInfluenza VaccinesmRNA VaccinesVaccines, CombinedAdolescentAdultAgedAntibodies, ViralFemaleHumansImmunogenicity, VaccineInfluenza, HumanMaleMiddle AgedRNA, MessengerAntibodies, ViralCOVID-19 VaccinesInfluenza VaccinesmRNA VaccinesRNA, MessengerVaccines, Combined

Identifiers

PMID40102593

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.