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- Title
An Adjuvanted, Postfusion F Protein-Based Vaccine Did Not Prevent Respiratory Syncytial Virus Illness in Older Adults.
- Authors
Falloon, Judith; Jing Yu; Esser, Mark T.; Villafana, Tonya; Li Yu; Dubovsky, Filip; Takas, Therese; Levin, Myron J.; Falsey, Ann R.; Yu, Jing; Yu, Li
- Abstract
<bold>Background: </bold>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.<bold>Methods: </bold>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.<bold>Results: </bold>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.<bold>Conclusion: </bold>The RSV vaccine was immunogenic but did not protect older adults from RSV illness.<bold>Clinical Trials Registration: </bold>NCT02508194.
- Subjects
RESPIRATORY syncytial virus infection vaccines; HEALTH of older people; VACCINE effectiveness; SYMPTOMS; PLACEBOS; BACTERIAL antigens; IMMUNOMODULATORS; CLINICAL trials; COMPARATIVE studies; DRUGS; GLYCOSIDES; IMMUNOGLOBULINS; INFLUENZA vaccines; LIPIDS; RESEARCH methodology; MEDICAL cooperation; PROTEINS; RESEARCH; RESPIRATORY syncytial virus; VIRAL antibodies; VIRAL antigens; EVALUATION research; VIRAL vaccines; RANDOMIZED controlled trials; BLIND experiment; ANTIBODY formation; RESPIRATORY syncytial virus infections; PREVENTION; VACCINES
- Publication
Journal of Infectious Diseases, 2017, Vol 216, Issue 11, p1362
- ISSN
0022-1899
- Publication type
journal article
- DOI
10.1093/infdis/jix503