A Randomized Phase 1/2 Study of a Respiratory Syncytial Virus Prefusion F Vaccine.

ABSTRACT:

Background

Protection against human respiratory syncytial virus (RSV) remains an unmet need potentially addressable by maternal immunization. This phase 1/2 study evaluated a bivalent prefusion F vaccine (RSVpreF) with antigens from RSV subgroups A and B.

Methods

Adults 18-49 years old (N = 618) were randomized to receive placebo or 60, 120, or 240 µg RSVpreF with or without Al(OH)3. Safety and immunogenicity were evaluated.

Results

RSVpreF recipients more frequently reported local reactions and systemic events than placebo recipients; these were mostly mild or moderate. No vaccine-related serious adverse events occurred through 12 months postvaccination. All RSVpreF formulations induced 1-month postvaccination virus-neutralizing titers higher than those associated wi

SUBMITTER: Walsh EE 

PROVIDER: S-EPMC9016447 | biostudies-literature | 2022 Apr

REPOSITORIES: biostudies-literature