Evidence map›Paper›PMID 40610413›Full record

Trial reportNature communications2025

Immune correlates analysis of mRNA-1345 RSV vaccine efficacy clinical trial.

Chong Ma, Jiejun Du, Lan Lan, Archana Kapoor, Gonzalo Perez Marc, Gilberto Jimenez, Christopher J A Duncan, Nancy Le Cam, Nina Lin, Frances Priddy and 8 more

Registry-linked trialAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Nature communications, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05127434 (A Phase 2/3, Randomized, Observer-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus), which is not on this map. Cited by 15 papers.

0numbers the graph read from it
0cells of the map it votes in
15citing 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.

NCT05127434 phase2 / phase3completednot on this map

A Phase 2/3, Randomized, Observer-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus (RSV), in Adults ≥60 Years of Age

TypeinterventionalSponsorModernaTX, Inc.Ran2021 to 2025Enrolled36,814ConditionsRespiratory Syncytial VirusArmsPlacebo, mRNA-1345
3 · Its place in the literature

Who cites it

15 citing papers in PubMed.

  1. Trial
  2. Trial
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  4. Respiratory Syncytial Virus Vaccination in Solid Organ Transplant Recipients: Interim Findings From a Phase 3 Trial of mRNA-1345.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2026
    Trial
  5. Review
  6. Review
  7. Article
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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

18 authors.

Chong MaModerna Inc, Cambridge, MA, USA.ORCID http://orcid.org/0000-0002-5054-9259
Jiejun DuModerna Inc, Cambridge, MA, USA.
Lan LanModerna Inc, Cambridge, MA, USA.
Archana KapoorModerna Inc, Cambridge, MA, USA.
Gonzalo Perez MarcHospital Militar Central Cirujano Mayor Dr. Cosme Argerich, Buenos Aires, Argentina.
Gilberto JimenezSpotlight Research Center LLC, Miami, FL, USA.
Christopher J A DuncanTranslational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, UK.
Nancy Le CamModerna Inc, Cambridge, MA, USA.
Nina LinModerna Inc, Cambridge, MA, USA.
Frances PriddyModerna Inc, Cambridge, MA, USA.
Sanjay GargModerna Inc, Cambridge, MA, USA.
Sonia K StoszekModerna Inc, Cambridge, MA, USA.
Christine A ShawModerna Inc, Cambridge, MA, USA.
Jaya GoswamiModerna Inc, Cambridge, MA, USA.
Eleanor WilsonModerna Inc, Cambridge, MA, USA.
Rituparna DasModerna Inc, Cambridge, MA, USA.
Honghong ZhouModerna Inc, Cambridge, MA, USA.
Lingyi ZhengModerna Inc, Cambridge, MA, USA. lingyi.zheng@modernatx.com.ORCID http://orcid.org/0000-0002-3446-3447

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Identifying an immunologic marker as a correlate of protection (CoP) for RSV vaccination is important. In the pivotal phase 3 trial, the mRNA-1345 vaccine demonstrated efficacy against RSV in older adults (NCT05127434). Here, we evaluate neutralizing antibodies (nAb) against RSV-A and -B, and IgG binding antibodies (bAb) to RSV fusion antigens as correlates of risk (CoR) and CoP against the pivotal trial's efficacy endpoints of RSV lower respiratory tract disease with ≥2 or ≥3 signs/symptoms (RSV-LRTD-2+ and -3 + ) and acute respiratory disease (RSV-ARD). Day 29 RSV nAb and prefusion (preF) IgG demonstrate consistent inverse correlates with RSV endpoint occurrence. Day 29 point estimates (95% CIs) of the hazard ratio of each endpoint (RSV-LRTD-2 + , RSV-LRTD-3 + , RSV-ARD) per 10-fold increase in RSV-A nAb are 0.44 (0.30-0.65), 0.41 (0.20-0.84), and 0.45 (0.28-0.71), respectively, similar to RSV-B nAb and preF IgG. These results demonstrate Day 29 RSV nAb and preF IgG are CoRs and support their role as CoPs against RSV endpoints.

Indexed as

Respiratory Syncytial Virus, HumanRespiratory Syncytial Virus InfectionsRespiratory Syncytial Virus VaccinesVaccine EfficacyAdultAgedAntibodies, NeutralizingAntibodies, ViralFemaleHumansImmunoglobulin GMaleMiddle AgedmRNA VaccinesAntibodies, NeutralizingAntibodies, ViralImmunoglobulin GmRNA-1345 respiratory syncytial virus vaccinemRNA VaccinesRespiratory Syncytial Virus Vaccines

Identifiers

PMID40610413
PMCPMC12229610

What OpenQuestion holds

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LicenceCC BY
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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.