Evidence map›Paper›PMID 41134084›Full record

SynthesisCPT: pharmacometrics & systems pharmacology2026

Establishing Immune Correlates of Protection Against Respiratory Syncytial Virus Infection to Accelerate Vaccine Development: A Model-Based Meta-Analysis.

Yushi Kashihara, Li Qin, Shinji Shimizu, Paul Matthias Diderichsen, Masakatsu Kotsuma, Kazutaka Yoshihara

Abstract readMeta-Analysis
In one paragraph

Synthesis in CPT: pharmacometrics & systems pharmacology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

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

  1. Pooled it
  2. Article
  3. Article
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

6 authors.

Yushi KashiharaDaiichi Sankyo Co. Ltd., Tokyo, Japan.ORCID https://orcid.org/0009-0002-0152-0238
Li QinCertara USA Inc., Radnor, Pennsylvania, USA.ORCID https://orcid.org/0000-0001-5002-3372
Shinji ShimizuDaiichi Sankyo Co. Ltd., Tokyo, Japan.
Paul Matthias DiderichsenCertara USA Inc., Radnor, Pennsylvania, USA.ORCID https://orcid.org/0000-0003-3567-7903
Masakatsu KotsumaDaiichi Sankyo Co. Ltd., Tokyo, Japan.
Kazutaka YoshiharaDaiichi Sankyo Co. Ltd., Tokyo, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The objectives of this study were to quantify the relationship between vaccine-induced immunogenicity responses and the protection against respiratory syncytial virus (RSV) infection-related clinical outcomes, and to evaluate immunogenicity as a surrogate marker for vaccine efficacy (VE) to accelerate RSV vaccine development. Serum neutralizing activity (SNA) and cell-mediated immunity (CMI) may serve as surrogate markers for the protection against RSV infection and are evaluated as immunogenicity endpoints in clinical trials of RSV vaccine candidates. Two meta-analytical approaches were applied to data from seven randomized placebo-controlled clinical trials that investigated RSV vaccines in older adults. The primary analysis examined the relationship between SNA and VE across three different clinical severity levels: (1) acute respiratory infection, (2) RSV lower respiratory tract disease (LRTD) with ≥ 2 clinical symptoms, and (3) RSV LRTD with ≥ 3 clinical symptoms (LRTD 3+). Furthermore, the additional contribution of CMI to VE, after accounting for the effect of SNA, was explored in a secondary analysis. The results demonstrated a positive correlation between SNA and VE across three clinical severity levels. Higher CMI was associated with higher VE specifically for RSV LRTD 3+, the most severe clinical level, suggesting that CMI may be correlated with additional clinical benefits in mitigating the severity of RSV infection. These findings provided preliminary evidence for immune correlates of protection against RSV infection and may aid in accelerating the development of new RSV vaccines.

Indexed as

Respiratory Syncytial Virus InfectionsRespiratory Syncytial Virus VaccinesVaccine DevelopmentAntibodies, NeutralizingAntibodies, ViralHumansImmunity, CellularRandomized Controlled Trials as TopicRespiratory Syncytial Virus, HumanVaccine EfficacyAntibodies, NeutralizingAntibodies, ViralRespiratory Syncytial Virus Vaccinesimmune correlates of protectionmodel‐based meta‐analysisrespiratory syncytial virus vaccine

Identifiers

PMID41134084
PMCPMC12896372

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

None linked

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.