Evidence map›Paper›PMID 29617814›Full record

Trial reportThe Journal of infectious diseases2018

A Respiratory Syncytial Virus Vaccine Based on the Small Hydrophobic Protein Ectodomain Presented With a Novel Lipid-Based Formulation Is Highly Immunogenic and Safe in Adults: A First-in-Humans Study.

Joanne M Langley, Lisa D MacDonald, Genevieve M Weir, Donna MacKinnon-Cameron, Lingyun Ye, Shelly McNeil, Bert Schepens, Xavier Saelens, Marianne M Stanford, Scott A Halperin

Open access · bronzeAbstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in The Journal of infectious diseases, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 39 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
39citing papers in PubMed, 3 pooled it
3.6field-weighted citation impact, top 7% 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.

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

39 citing papers in PubMed, 3 syntheses or guidelines pooled it, 56 citations in OpenAlex.

  1. Efficacy and safety of respiratory syncytial virus vaccines.The Cochrane database of systematic reviews · 2025
    Pooled it
  2. Vaccines for the common cold.The Cochrane database of systematic reviews · 2022
    Pooled it
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  9. Human anthrax vaccines: Current status and future prospects.Human vaccines & immunotherapeutics · 2025
    Review
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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

10 authors at 3 institutions in 2 countries.

Joanne M LangleyCanadian Center for Vaccinology (Dalhousie University, IWK Health Centre, and the Nova Scotia Health Authority).
Lisa D MacDonaldImmunovaccine, Halifax, Canada.
Genevieve M WeirImmunovaccine, Halifax, Canada.
Donna MacKinnon-CameronCanadian Center for Vaccinology (Dalhousie University, IWK Health Centre, and the Nova Scotia Health Authority).
Lingyun YeCanadian Center for Vaccinology (Dalhousie University, IWK Health Centre, and the Nova Scotia Health Authority).
Shelly McNeilCanadian Center for Vaccinology (Dalhousie University, IWK Health Centre, and the Nova Scotia Health Authority).
Bert SchepensVIB-UGent Center for Medical Biotechnology, VIB, Ghent University, Ghent, Belgium.
Xavier SaelensVIB-UGent Center for Medical Biotechnology, VIB, Ghent University, Ghent, Belgium.
Marianne M StanfordCanadian Center for Vaccinology (Dalhousie University, IWK Health Centre, and the Nova Scotia Health Authority).
Scott A HalperinCanadian Center for Vaccinology (Dalhousie University, IWK Health Centre, and the Nova Scotia Health Authority).
Dalhousie University · CAGhent University · BEImmunovaccine (Canada) · CA

Funding

CIHR
6 · The paper itself

Abstract

Background: Respiratory syncytial virus infection can cause lower respiratory tract infection in older adults comparable to influenza, but no vaccines are available. Methods: This was a randomized, observer-blinded, first-in-humans study of a novel synthetic RSV antigen based on the ectodomain of the small hydrophobic glycoprotein (SHe) of RSV subgroup A, formulated with either the lipid and oil-based vaccine platform DepoVax (DPX-RSV[A]) or alum (RSV[A]-Alum), in healthy, 50-64-year-old individuals. Two dose levels (10 or 25 µg) of SHe with each formulation were compared to placebo. A booster dose was administered on day 56. Results: There was no indication that the vaccine was unsafe. Mild pain, drowsiness, and muscles aches were the most common solicited adverse events (AEs), and the frequencies of the AEs did not increase after dose 2. Robust anti-SHe-specific immune responses were demonstrated in the DPX-RSV(A) 10-μg and 25-μg groups (geometric mean titer, approximately 10-fold and 100-fold greater than that of placebo at days 56 and 236, respectively), and responses were sustained in the DPX-RSV(A) 25-μg group at day 421. Responses to the RSV(A)-Alum vaccines were very low. Conclusions: A novel antigen from the SH protein of RSV, formulated in a lipid and oil-based vaccine platform, was highly immunogenic, with sustained antigen-specific antibody responses, and had an acceptable safety profile.

Indexed as

Adjuvants, ImmunologicAlum CompoundsAntibodies, ViralDrug-Related Side Effects and Adverse ReactionsFemaleHealthy VolunteersHumansImmunity, HumoralImmunization ScheduleLipidsMaleMiddle AgedPlacebosRespiratory Syncytial Virus, HumanRespiratory Syncytial Virus InfectionsRespiratory Syncytial Virus VaccinesAdjuvants, ImmunologicAlum Compoundsaluminum sulfateAntibodies, ViralLipidsPlacebosRespiratory Syncytial Virus VaccinesRetroviridae Proteins, Oncogenicsmall hydrophobic protein, virusVaccines, Subunit

Identifiers

PMID29617814
PMCPMC6049039
OpenAlexW2794724225

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.