Immunogenicity and Safety of 3 Formulations of a Respiratory Syncytial Virus Candidate Vaccine in Nonpregnant Women: A Phase 2, Randomized Trial
Tino F Schwarz, Roderick A McPhee, Odile Launay, Geert Leroux-Roels, Jaak Talli, Marta Picciolato, Feng Gao, Rongman Cai, Thi Lien-Anh Nguyen, Ilse Dieussaert, Jacqueline M Miller, Alexander C Schmidt, Tino F Schwarz, Roderick A McPhee, Odile Launay, Geert Leroux-Roels, Jaak Talli, Marta Picciolato, Feng Gao, Rongman Cai, Thi Lien-Anh Nguyen, Ilse Dieussaert, Jacqueline M Miller, Alexander C Schmidt
Abstract
Background: 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.
Methods: 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.
Results: 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.
Conclusions: 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.
Clinical trials registration: NCT02956837.
Keywords: maternal immunization; neutralizing antibodies; nonpregnant women; palivizumab competing antibody; randomized trial; respiratory syncytial virus; safety.
© The Author(s) 2019. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.
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