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

Department

Infectious Diseases

Document Type

Article

Publication Title

The Journal of Infectious Diseases

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.

First Page

1362

Last Page

1370

DOI

10.1093/infdis/jix503

Volume

216

Issue

11

Publication Date

12-12-2017

Medical Subject Headings

Adjuvants, Immunologic (administration & dosage); Adjuvants, Pharmaceutic; Aged; Antibodies, Neutralizing (blood); Antibodies, Viral (blood); Antibody Formation; Antigens, Bacterial; Antigens, Viral (immunology); Double-Blind Method; Female; Glucosides (pharmacology); Humans; Immunoglobulin G (blood); Influenza Vaccines (immunology); Lipid A (pharmacology); Male; Middle Aged; Respiratory Syncytial Virus Infections (immunology, prevention & control); Respiratory Syncytial Virus Vaccines (immunology, therapeutic use); Respiratory Syncytial Virus, Human (immunology); Viral Fusion Proteins (administration & dosage, immunology)

PubMed ID

29029260

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