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- Title
Immunogenicity and Safety of 3 Formulations of a Respiratory Syncytial Virus Candidate Vaccine in Nonpregnant Women: A Phase 2, Randomized Trial.
- Authors
Schwarz, Tino F; McPhee, Roderick A; Launay, Odile; Leroux-Roels, Geert; Talli, Jaak; Picciolato, Marta; Gao, Feng; Cai, Rongman; Nguyen, Thi Lien-Anh; Dieussaert, Ilse; Miller, Jacqueline M; Schmidt, Alexander C
- Abstract
<bold>Background: </bold>Respiratory syncytial virus (RSV) is a common cause of respiratory tract illness and hospitalization in neonates and infants. RSV vaccination during pregnancy may protect offspring in their first months of life.<bold>Methods: </bold>This randomized, observer-blind, multicenter, phase 2 study evaluated the immunogenicity and safety of an RSV candidate vaccine in healthy nonpregnant women aged 18-45 years. Four hundred participants were randomized (1:1:1:1) to receive a single intramuscular dose of vaccine containing 30 µg, 60 µg, or 120 µg of RSV fusion protein engineered to preferentially maintain a prefusion conformation (RSV-PreF vaccine) or placebo.<bold>Results: </bold>Thirty days postvaccination, RSV-A neutralizing antibody geometric mean titers (GMTs) increased 3.75-, 4.42- and 4.36-fold; RSV-B neutralizing antibody GMTs 2.36-, 2.54- and 2.76-fold; and palivizumab competing antibody (PCA) concentrations 11.69-, 14.38- and 14.24-fold compared with baseline levels in the 30 µg, 60 µg, and 120 µg RSV-PreF groups, respectively. Antibody titers and PCA concentrations at day 30 were significantly higher with the 120 µg compared to the 30 µg RSV-PreF vaccine. All RSV-PreF vaccine formulations and the placebo had similar reactogenicity profiles. No serious adverse events were considered to be related to the RSV-PreF vaccine.<bold>Conclusions: </bold>The 3 formulations of the investigational RSV-PreF vaccine were well-tolerated and induced RSV-A and RSV-B neutralizing antibodies and PCAs in healthy, nonpregnant women.<bold>Clinical Trials Registration: </bold>NCT02956837.
- Subjects
VIRAL vaccines; RESPIRATORY syncytial virus; CLINICAL trial registries; CHIMERIC proteins; PROTEIN engineering
- Publication
Journal of Infectious Diseases, 2019, Vol 220, Issue 11, p1816
- ISSN
0022-1899
- Publication type
journal article
- DOI
10.1093/infdis/jiz395