Evidence map›Paper›PMID 37433021›Full record

Trial reportThe Journal of infectious diseases2024

Safety, Immunogenicity, and Regimen Selection of Ad26.RSV.preF-Based Vaccine Combinations: A Randomized, Double-blind, Placebo-Controlled, Phase 1/2a Study.

Christy A Comeaux, Stephan Bart, Arangassery Rosemary Bastian, Vladislav Klyashtornyy, Els De Paepe, Edmund Omoruyi, Leslie van der Fits, Roy van Heesbeen, Esther Heijnen, Benoit Callendret and 1 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IClinical Trial, Phase IIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Journal of infectious diseases, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03502707 (A Randomized, Double-blind, Placebo-controlled Phase 1/2a Study for Safety and Immunogenicity Evaluations for Regimen Selection of Ad26.RSV.preF and/or RSV preF Protein Combinations Followed by Expanded Safety Evaluation in Adults Aged 60 Years and Older), which is not on this map. Cited by 15 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 1 pooled it
4.3field-weighted citation impact, top 5% 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.

NCT03502707 phase1 / phase2completednot on this map

A Randomized, Double-blind, Placebo-controlled Phase 1/2a Study for Safety and Immunogenicity Evaluations for Regimen Selection of Ad26.RSV.preF and/or RSV preF Protein Combinations Followed by Expanded Safety Evaluation in Adults Aged 60 Years and Older

TypeinterventionalSponsorJanssen Vaccines & Prevention B.V.Ran2018 to 2022Enrolled669ConditionsHealthyArmsPlacebo, RSV preF Protein 50 mcg, RSV preF Protein 150 mcg, Ad26.RSV.preF 1*10^11 vp, Mixture of Ad26.RSV.preF 5*10^10 vp Plus RSV preF Protein 50 mcg
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 1 synthesis or guideline pooled it, 20 citations in OpenAlex.

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  6. Developing the next-generation of adenoviral vector vaccines.Human vaccines & immunotherapeutics · 2025
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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

11 authors at 2 institutions in 2 countries.

Christy A ComeauxJanssen Vaccines & Prevention B.V., Leiden, the Netherlands.
Stephan BartTrial Professionals Consultant Group, Inc., Woodstock, Maryland.
Arangassery Rosemary BastianJanssen Vaccines & Prevention B.V., Leiden, the Netherlands.
Vladislav KlyashtornyyJanssen Infectious Diseases, Beerse, Belgium.
Els De PaepeJanssen Infectious Diseases, Beerse, Belgium.
Edmund OmoruyiJanssen Infectious Diseases, Beerse, Belgium.
Leslie van der FitsJanssen Vaccines & Prevention B.V., Leiden, the Netherlands.
Roy van HeesbeenJanssen Vaccines & Prevention B.V., Leiden, the Netherlands.
Esther HeijnenJanssen Vaccines & Prevention B.V., Leiden, the Netherlands.
Benoit CallendretJanssen Vaccines & Prevention B.V., Leiden, the Netherlands.
Jerald SadoffJanssen Vaccines & Prevention B.V., Leiden, the Netherlands.
Janssen (Netherlands) · NLJanssen (Belgium) · BE

Funding

Janssen Vaccines & Prevention BV
6 · The paper itself

Abstract

backgroundAd26.RSV.preF is an adenovirus serotype 26 vector-based respiratory syncytial virus (RSV) vaccine encoding a prefusion conformation-stabilized RSV fusion protein (preF) that demonstrated robust humoral and cellular immunogenicity and showed promising efficacy in a human challenge study in younger adults. Addition of recombinant RSV preF protein might enhance RSV-specific humoral immune responses, especially in older populations.

methodsThis randomized, double-blind, placebo-controlled, phase 1/2a study compared the safety and immunogenicity of Ad26.RSV.preF alone and varying doses of Ad26.RSV.preF-RSV preF protein combinations in adults aged ≥60 years. This report includes data from cohort 1 (initial safety, n = 64) and cohort 2 (regimen selection, n = 288). Primary immunogenicity and safety analyses were performed 28 days postvaccination (cohort 2) for regimen selection.

resultsAll vaccine regimens were well tolerated, with similar reactogenicity profiles among them. Combination regimens induced greater humoral immune responses (virus-neutralizing and preF-specific binding antibodies) and similar cellular ones (RSV-F-specific T cells) as compared with Ad26.RSV.preF alone. Vaccine-induced immune responses remained above baseline up to 1.5 years postvaccination.

conclusionsAll Ad26.RSV.preF-based regimens were well tolerated. A combination regimen comprising Ad26.RSV.preF, which elicits strong humoral and cellular responses, and RSV preF protein, which increases humoral responses, was selected for further development. Clinical Trials Registration. NCT03502707.

Indexed as

Respiratory Syncytial Virus, HumanRespiratory Syncytial Virus InfectionsRespiratory Syncytial Virus VaccinesAgedAntibodies, NeutralizingAntibodies, ViralHumansImmunity, HumoralImmunogenicity, VaccineMiddle AgedAntibodies, NeutralizingAntibodies, ViralRespiratory Syncytial Virus Vaccinesadenovirus serotype 26adult vaccinationrespiratory syncytial virusrespiratory syncytial virus vaccinevirus fusion proteins

Identifiers

PMID37433021
PMCPMC10786248
OpenAlexW4383896799

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.