Safety and Immunogenicity of an Investigational Respiratory Syncytial Virus Vaccine (RSVPreF3) in Mothers and Their Infants: A Phase 2 Randomized Trial.

ABSTRACT:

Background

In a phase 1/2 study, a maternal respiratory syncytial virus vaccine candidate (RSVPreF3) demonstrated an acceptable safety profile and efficiently increased RSV-specific humoral immune responses in non-pregnant women.

Methods

In this phase 2 observer-blind, placebo-controlled, randomized clinical trial (NCT04126213), the safety of RSVPreF3 (60 or 120 µg), administered during late second or third trimester, was evaluated in 213 18- to 40-year-old healthy pregnant women through 6 months postdelivery and their offspring through infancy; immunogenicity was evaluated through day 43 postdelivery and day 181 postbirth, respectively.

Results

RSVPreF3 was well tolerated. No pregnancy-related or neonatal adverse events of special interest were considered vaccine/pla

SUBMITTER: Bebia Z 

PROVIDER: S-EPMC10420396 | biostudies-literature | 2023 Aug

REPOSITORIES: biostudies-literature