Evidence map›Paper›PMID 37336877›Full record

Trial reportNature communications2023

Safety and immunogenicity of a phase 1/2 randomized clinical trial of a quadrivalent, mRNA-based seasonal influenza vaccine (mRNA-1010) in healthy adults: interim analysis.

Ivan T Lee, Raffael Nachbagauer, David Ensz, Howard Schwartz, Lizbeth Carmona, Kristi Schaefers, Andrei Avanesov, Daniel Stadlbauer, Carole Henry, Ren Chen and 4 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled TrialClinical Trial, Phase IClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Nature communications, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04956575 (A Phase 1/2, Randomized, Stratified, Observer-Blind, Dose-Ranging Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1010 Seasonal Influenza Vaccine in Healthy Adults 18 Years and Older), which is not on this map. Cited by 87 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
87citing papers in PubMed, 2 pooled it
21.9field-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.

NCT04956575 phase1 / phase2completednot on this map

A Phase 1/2, Randomized, Stratified, Observer-Blind, Dose-Ranging Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1010 Seasonal Influenza Vaccine in Healthy Adults 18 Years and Older

TypeinterventionalSponsorModernaTX, Inc.Ran2021 to 2022Enrolled885ConditionsSeasonal InfluenzaArmsmRNA-1010, Placebo, Active Comparator
3 · Its place in the literature

Who cites it

87 citing papers in PubMed, 2 syntheses or guidelines pooled it, 103 citations in OpenAlex.

  1. Pooled it
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  3. Trial
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  9. Article
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  11. Towards mRNA therapeutics 2.0.Nature reviews. Drug discovery · 2026
    Review
  12. Article
  13. Article
  14. Observational
  15. mRNA Vaccines for Influenza: Hope for a Universal Vaccine?BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2026
    Review
  16. Review
  17. Article
  18. Article
  19. Article
  20. Review

27 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

14 authors at 3 institutions in 1 country.

Ivan T LeeModerna, Inc., Cambridge, MA, USA.
Raffael NachbagauerModerna, Inc., Cambridge, MA, USA. Raffael.Nachbagauer@modernatx.com.ORCID 0000-0001-5568-5420
David EnszMeridian Clinical Research, Sioux City, IA, USA.
Howard SchwartzResearch Centers of America, Hollywood, FL, USA.
Lizbeth CarmonaModerna, Inc., Cambridge, MA, USA.
Kristi SchaefersModerna, Inc., Cambridge, MA, USA.
Andrei AvanesovModerna, Inc., Cambridge, MA, USA.
Daniel StadlbauerModerna, Inc., Cambridge, MA, USA.
Carole HenryModerna, Inc., Cambridge, MA, USA.
Ren ChenModerna, Inc., Cambridge, MA, USA.
Wenmei HuangModerna, Inc., Cambridge, MA, USA.
Daniela Ramirez SchremppModerna, Inc., Cambridge, MA, USA.
Jintanat AnanworanichModerna, Inc., Cambridge, MA, USA.
Robert ParisModerna, Inc., Cambridge, MA, USA. Robert.Paris@modernatx.com.
Moderna Therapeutics (United States) · USCancer Treatment Centers of America · USMeridian Clinical Research · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Despite vaccine availability, influenza remains a substantial global public health concern. Here, we report interim findings on the primary and secondary objectives of the safety, reactogenicity, and humoral immunogenicity of a quadrivalent messenger RNA (mRNA) vaccine against seasonal influenza, mRNA-1010, from the first 2 parts of a 3-part, first-in-human, phase 1/2 clinical trial in healthy adults aged ≥18 years (NCT04956575). In the placebo-controlled Part 1, a single dose of mRNA-1010 (50 µg, 100 µg, or 200 µg) elicited hemagglutination inhibition (HAI) titers against vaccine-matched strains. In the active-comparator-controlled Part 2, mRNA-1010 (25 µg, 50 µg, or 100 µg) elicited higher HAI titers than a standard dose, inactivated seasonal influenza vaccine for influenza A strains and comparable HAI titers for influenza B strains. No safety concerns were identified; solicited adverse reactions were dose-dependent and more frequent after receipt of mRNA-1010 than the active comparator. These interim data support continued development of mRNA-1010.

Indexed as

Influenza, HumanInfluenza VaccinesAdolescentAdultAntibodies, ViralDouble-Blind MethodHemagglutination Inhibition TestsHumansmRNA VaccinesSeasonsVaccines, CombinedVaccines, InactivatedAntibodies, ViralInfluenza VaccinesmRNA-1010 influenza vaccinemRNA VaccinesVaccines, CombinedVaccines, Inactivated

Identifiers

PMID37336877
PMCPMC10279702
OpenAlexW4381190545

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.