Study of an Live-Attenuated Respiratory Syncytial Virus Vaccine in Infants and Toddlers

Summary

The primary objectives of the study were: * To assess the safety profile of each dose of the study product after each and any administration in all infants and toddlers regardless of baseline serostatus. * To characterize the Respiratory Syncytial Virus (RSV) A serum neutralizing antibody responses to the study product in each vaccine group after vaccination in RSV-naïve participants. The secondary objectives of the study were: * To quantify the amount of vaccine virus shed by each participant by baseline serostatus. * To determine the proportion of vaccinated infants and toddlers in each vaccine group infected with the vaccine virus at D56 (56 days after vaccination 1) for Cohorts 1, 2, 3 and 4, and at Day 84 (28 days after vaccination 2) for Cohorts 2 and 4 by baseline serostatus. * To characterize the RSV A serum neutralizing antibody responses to the study product in each vaccine group after vaccination in RSV-experienced participants. * To characterize serum RSV anti-F immunoglobulin G (IgG) antibody responses to the study product in each vaccine group after vaccination by baseline serostatus. * To characterize serum RSV antibody responses (RSV A-neutralizing and anti-RSV F IgG) to the study product in each vaccine group after the RSV surveillance season or at least 5 months after the last vaccine administration by baseline serostatus.

Timeline

Start

2020-09-17

Primary completion

2023-04-13

Completion

2023-04-13

Publications

• Idoko OT, Vargas SL, Bueso A, Rivera D, Edward H, Simon M, Banooni P, Berger S, Janicot S, Vercasson C, Pallardy S, Nteene R, Adhikarla H, Gerchman E, Gasparotto M, Gallichan S, Rivas E, Buchholz UJ, Collins PL, Sesay S, Gurunathan S, De Bruijn I, Dhingra MS. Live-Attenuated Intranasal RSV Vaccine in Infants and Toddlers. NEJM Evid. 2025 Sep;4(9):EVIDoa2500026. doi: 10.1056/EVIDoa2500026. Epub 2025 Aug 26.

Drugs

Indications