Evidence map›Paper›PMID 31340042›Full record

Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2020

First-in-Human Randomized Study to Assess the Safety and Immunogenicity of an Investigational Respiratory Syncytial Virus (RSV) Vaccine Based on Chimpanzee-Adenovirus-155 Viral Vector-Expressing RSV Fusion, Nucleocapsid, and Antitermination Viral Proteins in Healthy Adults.

Paola Cicconi, Claire Jones, Esha Sarkar, Laura Silva-Reyes, Paul Klenerman, Catherine de Lara, Claire Hutchings, Philippe Moris, Michel Janssens, Laurence A Fissette and 5 more

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02491463 (A Study to Evaluate Safety, Reactogenicity and Immunogenicity of GSK Biologicals' RSV Investigational Vaccine Based on Viral Proteins Encoded by Chimpanzee-derived Adenovector), which is not on this map. Cited by 41 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
41citing papers in PubMed, 2 pooled it
5.6field-weighted citation impact, top 3% 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.

NCT02491463 phase1completednot on this map

A Study to Evaluate Safety, Reactogenicity and Immunogenicity of GSK Biologicals' RSV Investigational Vaccine Based on Viral Proteins Encoded by Chimpanzee-derived Adenovector (ChAd155-RSV) (GSK3389245A) in Healthy Adults

TypeinterventionalSponsorGlaxoSmithKlineRan2015 to 2017Enrolled73ConditionsRespiratory Synctial Virus InfectionsArmsGSK3389245A_LD GROUP, GSK3389245A_HD GROUP, Bexsero, Placebo
3 · Its place in the literature

Who cites it

41 citing papers in PubMed, 2 syntheses or guidelines pooled it, 57 citations in OpenAlex.

  1. Vaccines for the common cold.The Cochrane database of systematic reviews · 2022
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  9. Developing the next-generation of adenoviral vector vaccines.Human vaccines & immunotherapeutics · 2025
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

15 authors at 4 institutions in 3 countries.

Paola CicconiOxford Vaccine Group, Department of Paediatrics, University of Oxford, United Kingdom.
Claire JonesOxford Vaccine Group, Department of Paediatrics, University of Oxford, United Kingdom.
Esha SarkarOxford Vaccine Group, Department of Paediatrics, University of Oxford, United Kingdom.
Laura Silva-ReyesOxford Vaccine Group, Department of Paediatrics, University of Oxford, United Kingdom.
Paul KlenermanNuffield Department of Medicine, University of Oxford, United Kingdom.
Catherine de LaraNuffield Department of Medicine, University of Oxford, United Kingdom.
Claire HutchingsNuffield Department of Medicine, University of Oxford, United Kingdom.
Philippe MorisGSK, Rixensart, Belgium.
Michel JanssensGSK, Rixensart, Belgium.
Laurence A FissetteGSK, Wavre, Belgium.
Marta PicciolatoGSK, Rixensart, Belgium.
Amanda LeachGSK, Rockville, Maryland.
Antonio Gonzalez-LopezGSK, Rockville, Maryland.
Ilse DieussaertGSK, Rockville, Maryland.
Matthew D SnapeOxford Vaccine Group, Department of Paediatrics, University of Oxford, United Kingdom.
University of Oxford · GBGlaxoSmithKline (Belgium) · BEGlaxoSmithKline (United States) · USNational Institute for Health Research · GB

Funding

Wellcome Trust 109965/Z/15/Z
6 · The paper itself

Abstract

backgroundRespiratory syncytial virus (RSV) disease is a major cause of infant morbidity and mortality. This Phase I, randomized, observer-blind, placebo- and active-controlled study evaluated an investigational vaccine against RSV (ChAd155-RSV) using the viral vector chimpanzee-adenovirus-155, encoding RSV fusion (F), nucleocapsid, and transcription antitermination proteins.

methodsHealthy 18-45-year-old adults received ChAd155-RSV, a placebo, or an active control (Bexsero) at Days (D) 0 and 30. An escalation from a low dose (5 × 109 viral particles) to a high dose (5 × 1010 viral particles) occurred after the first 16 participants. Endpoints were solicited/unsolicited and serious adverse events (SAEs), biochemical/hematological parameters, cell-mediated immunogenicity by enzyme-linked immunospot, functional neutralizing antibodies, anti RSV-F immunoglobin (Ig) G, and ChAd155 neutralizing antibodies.

resultsThere were 7 participants who received the ChAd155-RSV low dose, 31 who received the ChAd155-RSV high dose, 19 who received the placebo, and 15 who received the active control. No dose-related toxicity or attributable SAEs at the 1-year follow-up were observed. The RSV-A neutralizing antibodies geometric mean titer ratios (post/pre-immunization) following a high dose were 2.6 (D30) and 2.3 (D60). The ratio of the fold-rise (D0 to D30) in anti-F IgG over the fold-rise in RSV-A-neutralizing antibodies was 1.01. At D7 after the high dose of the study vaccine, the median frequencies of circulating B-cells secreting anti-F antibodies were 133.3/106 (IgG) and 16.7/106 (IgA) in peripheral blood mononuclear cells (PBMCs). The median frequency of RSV-F-specific interferon γ-secreting T-cells after a ChAd155-RSV high dose was 108.3/106 PBMCs at D30, with no increase after the second dose.

conclusionsIn adults previously naturally exposed to RSV, ChAd155-RSV generated increases in specific humoral and cellular immune responses without raising significant safety concerns. CLINICAL TRIALS REGISTRATION: NCT02491463.

Indexed as

Respiratory Syncytial Virus InfectionsRespiratory Syncytial Virus VaccinesAdenoviridaeAdolescentAdultAnimalsAntibodies, NeutralizingAntibodies, ViralHumansLeukocytes, MononuclearMiddle AgedNucleocapsidPan troglodytesViral ProteinsVirionYoung AdultAntibodies, NeutralizingAntibodies, ViralRespiratory Syncytial Virus VaccinesViral Proteinsfirst-in-human studyRSVviral vector vaccine

Identifiers

PMID31340042
PMCPMC7201425
OpenAlexW2962696674

What OpenQuestion holds

Textmetadata
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.