Evidence map›Paper›PMID 29029260›Full record

Trial reportThe Journal of infectious diseases2017

An Adjuvanted, Postfusion F Protein-Based Vaccine Did Not Prevent Respiratory Syncytial Virus Illness in Older Adults.

Judith Falloon, Jing Yu, Mark T Esser, Tonya Villafana, Li Yu, Filip Dubovsky, Therese Takas, Myron J Levin, Ann R Falsey

Registry-linked trialAbstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Journal of infectious diseases, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02508194 (A Phase 2b Randomized, Double-blind Study to Evaluate the Efficacy of MEDI7510 for the Prevention of Acute Respiratory Syncytial Virus-associated Respiratory Illness in Older Adults), which is not on this map. Cited by 73 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
73citing papers in PubMed, 7 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.

NCT02508194 phase2terminatednot on this map

A Phase 2b Randomized, Double-blind Study to Evaluate the Efficacy of MEDI7510 for the Prevention of Acute Respiratory Syncytial Virus-associated Respiratory Illness in Older Adults

TypeinterventionalSponsorMedImmune LLCRan2015 to 2016Enrolled1,900ConditionsRespiratory Syncytial VirusArmsMEDI7510, IIV, Placebo
3 · Its place in the literature

Who cites it

73 citing papers in PubMed, 7 syntheses or guidelines pooled it.

  1. Pooled it
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  3. Efficacy and safety of respiratory syncytial virus vaccines.The Cochrane database of systematic reviews · 2025
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  6. Vaccines for the common cold.The Cochrane database of systematic reviews · 2022
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13 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors.

Judith FalloonMedImmune, Gaithersburg, Maryland.
Jing YuMedImmune, Gaithersburg, Maryland.
Mark T EsserMedImmune, Gaithersburg, Maryland.
Tonya VillafanaMedImmune, Gaithersburg, Maryland.
Li YuMedImmune, Gaithersburg, Maryland.
Filip DubovskyMedImmune, Gaithersburg, Maryland.
Therese TakasMedImmune, Gaithersburg, Maryland.
Myron J LevinUniversity of Colorado Anschutz Medical Campus, Aurora.
Ann R FalseyRochester General Hospital and University of Rochester, New York.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Respiratory syncytial virus (RSV) is an important cause of illness in older adults. This study assessed efficacy of a vaccine for prevention of RSV-associated acute respiratory illness (ARI), defined by specified symptoms with virologic confirmation. Methods: This phase 2b study evaluated RSV postfusion F protein (120 µg) with glucopyranosyl lipid adjuvant (5 µg) in 2% stable emulsion. Subjects aged ≥60 years were randomly assigned at a ratio of 1:1 to receive vaccine or placebo (all received inactivated influenza vaccine). Ill subjects recorded symptoms and provided blood and nasal swab samples. Results: In the per-protocol population (n = 1894), the incidence of RSV-associated ARI occurring ≥14 days after dosing was 1.7% and 1.6% in the vaccine and placebo groups, respectively, for a vaccine efficacy (VE) of -7.1% (90% confidence interval [CI], -106.9%-44.3%). Efficacy was not observed in secondary analyses that included seroresponse to nonvaccine RSV antigens (VE, 8.9%; 90% CI, -28.5%-35.4%) or symptoms combined with seroresponse (VE, 10.0%; 90% CI, -45.4%-44.4%). On day 29, 92.9% of vaccinees had an anti-F immunoglobulin G antibody seroresponse. Overall, 48.5% and 30.9% of RSV vaccine recipients reported local and systemic solicited symptoms, respectively. Conclusion: The RSV vaccine was immunogenic but did not protect older adults from RSV illness. Clinical Trials Registration: NCT02508194.

Indexed as

Adjuvants, ImmunologicAdjuvants, PharmaceuticAgedAntibodies, NeutralizingAntibodies, ViralAntibody FormationAntigens, BacterialAntigens, ViralDouble-Blind MethodFemaleGlucosidesHumansImmunoglobulin GInfluenza VaccinesLipid AMaleAdjuvants, ImmunologicAdjuvants, PharmaceuticAntibodies, NeutralizingAntibodies, ViralAntigens, BacterialAntigens, ViralF protein, human respiratory syncytial virusglucopyranosyl lipid-AGlucosidesImmunoglobulin GInfluenza VaccinesLipid ARespiratory Syncytial Virus VaccinesvaccinViral Fusion ProteinsAdjuvantclinical trialefficacyrespiratory syncytial virussubunitvaccine

Identifiers

PMID29029260
PMCPMC5853767

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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.