Immune persistence and safety of the AS01_E-adjuvanted respiratory syncytial virus prefusion F protein-based vaccine in adults 50-59 years of age, including at-increased-risk adults: A randomized controlled trial.

ABSTRACT: In this phase 3, randomized, placebo-controlled multi-country study, the AS01_E-adjuvanted respiratory syncytial virus (RSV) prefusion F protein-based vaccine (adjuvanted RSVPreF3) was immunologically non-inferior at 1 month post-vaccination in adults 50-59 years of age (YOA) compared to adults ≥60 YOA, in whom efficacy was previously demonstrated. Here, we report end-of-study immunogenicity and safety results until 12 months post-vaccination. Participants 50-59 YOA were divided into an at-increased-risk (AIR) and a non-AIR subcohort, each randomized (2:1) to receive one dose of adjuvanted RSVPreF3 or placebo. A control cohort of participants ≥60 YOA received adjuvanted RSVPreF3. Humoral/cell-mediated immunity and safety were assessed. In total, 1152 participants 50-59 YOA receiv

SUBMITTER: Ferguson M 

PROVIDER: S-EPMC12599337 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature