Evidence map›Paper›PMID 33400792›Full record

Trial reportThe Journal of infectious diseases2022

Prevention of Respiratory Syncytial Virus Infection in Healthy Adults by a Single Immunization of Ad26.RSV.preF in a Human Challenge Study.

Jerald Sadoff, Els De Paepe, John DeVincenzo, Efi Gymnopoulou, Joris Menten, Bryan Murray, Arangassery Rosemary Bastian, An Vandebosch, Wouter Haazen, Nicolas Noulin and 7 more

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in The Journal of infectious diseases, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03334695 (An Exploratory, Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Prophylactic Efficacy of a Single Immunization of Ad26.RSV.preF Against Respiratory Syncytial Virus Infection in a Virus Challenge Model in Healthy 18 to 50 Year-Old Adults), which is not on this map. Cited by 54 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
54citing papers in PubMed, 3 pooled it
11.1field-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.

NCT03334695 phase2completednot on this map

An Exploratory, Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Prophylactic Efficacy of a Single Immunization of Ad26.RSV.preF Against Respiratory Syncytial Virus Infection in a Virus Challenge Model in Healthy 18 to 50 Year-Old Adults

TypeinterventionalSponsorJanssen Vaccines & Prevention B.V.Ran2017 to 2018Enrolled64ConditionsHealthyArmsAd26.RSV.preF, Placebo
3 · Its place in the literature

Who cites it

54 citing papers in PubMed, 3 syntheses or guidelines pooled it, 90 citations in OpenAlex.

  1. Efficacy and safety of respiratory syncytial virus vaccines.The Cochrane database of systematic reviews · 2025
    Pooled it
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  3. Vaccines for the common cold.The Cochrane database of systematic reviews · 2022
    Pooled it
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  13. 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

17 authors at 4 institutions in 4 countries.

Jerald SadoffJanssen Vaccines and Prevention BV, Leiden, The Netherlands.
Els De PaepeJanssen Infectious Diseases, Beerse, Belgium.
John DeVincenzoUniversity of Tennessee School of Medicine, Memphis, Tennessee, USA.
Efi GymnopoulouJanssen Infectious Diseases, Beerse, Belgium.
Joris MentenJanssen Infectious Diseases, Beerse, Belgium.
Bryan MurrayhVIVO, London, United Kingdom.
Arangassery Rosemary BastianJanssen Vaccines and Prevention BV, Leiden, The Netherlands.
An VandeboschJanssen Infectious Diseases, Beerse, Belgium.
Wouter HaazenJanssen Infectious Diseases, Beerse, Belgium.
Nicolas NoulinhVIVO, London, United Kingdom.
Christy ComeauxJanssen Vaccines and Prevention BV, Leiden, The Netherlands.
Esther HeijnenJanssen Vaccines and Prevention BV, Leiden, The Netherlands.
Kingsley EzehVIVO, London, United Kingdom.
Anthony GilberthVIVO, London, United Kingdom.
Rob Lambkin-WilliamshVIVO, London, United Kingdom.
Hanneke SchuitemakerJanssen Vaccines and Prevention BV, Leiden, The Netherlands.
Benoit CallendretJanssen Vaccines and Prevention BV, Leiden, The Netherlands.
Janssen (Netherlands) · NLhVIVO (United Kingdom) · GBJanssen (Belgium) · BEUniversity of Tennessee Health Science Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRespiratory syncytial virus (RSV) is a significant cause of severe lower respiratory tract disease in children and older adults, but has no approved vaccine. This study assessed the potential of Ad26.RSV.preF to protect against RSV infection and disease in an RSV human challenge model.

methodsIn this double-blind, placebo-controlled study, healthy adults aged 18-50 years were randomized 1:1 to receive 1 × 1011 vp Ad26.RSV.preF or placebo intramuscularly. Twenty-eight days postimmunization, volunteers were challenged intranasally with RSV-A (Memphis 37b). Assessments included viral load (VL), RSV infections, clinical symptom score (CSS), safety, and immunogenicity.

resultsPostchallenge, VL, RSV infections, and disease severity were lower in Ad26.RSV.preF (n = 27) vs placebo (n = 26) recipients: median VL area under the curve (AUC) quantitative real-time polymerase chain reaction: 0.0 vs 236.0 (P = .012; predefined primary endpoint); median VL-AUC quantitative culture: 0.0 vs 109; RSV infections 11 (40.7%) vs 17 (65.4%); median RSV AUC-CSS 35 vs 167, respectively. From baseline to 28 days postimmunization, geometric mean fold increases in RSV A2 neutralizing antibody titers of 5.8 and 0.9 were observed in Ad26.RSV.preF and placebo, respectively. Ad26.RSV.preF was well tolerated.

conclusionsAd26.RSV.preF demonstrated protection from RSV infection through immunization in a human challenge model, and therefore could potentially protect against natural RSV infection and disease. CLINICAL TRIALS REGISTRATION: NCT03334695; CR108398, 2017-003194-33 (EudraCT); VAC18193RSV2002.

Indexed as

Respiratory Syncytial Virus, HumanRespiratory Syncytial Virus InfectionsRespiratory Syncytial Virus VaccinesAgedAntibodies, NeutralizingAntibodies, ViralChildHumansImmunizationViral Fusion ProteinsAntibodies, NeutralizingAntibodies, ViralRespiratory Syncytial Virus VaccinesViral Fusion Proteinsadenoviral vectorsadultschallenge studyPre-F proteinrespiratory syncytial virusRSV fusion proteinvaccine

Identifiers

PMID33400792
PMCPMC9417128
OpenAlexW3120740310

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.