A Randomized Phase 1 Clinical Trial of a Respiratory Syncytial Virus and Human Metapneumovirus Combination Protein-Based Virus-like Particle Vaccine in Adults 60-75 Years of Age.

ABSTRACT:

Background

Respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) are important causes of severe lower respiratory tract disease (LRTD) in adults ≥65 years of age. We report safety and immunogenicity for IVX-A12, a combination, protein-based virus-like particle (VLP) vaccine against RSV- and hMPV-associated LRTD.

Methods

This phase 1 trial (NCT05664334) randomized healthy adults 60-75 years of age to receive 1 intramuscular dose of IVX-A12 at low (75 µg RSV/75 µg hMPV), medium (75 µg RSV/150 µg hMPV), or high dose levels (75 µg RSV/225 µg hMPV) ± oil-in-water adjuvant MF59® (low and medium dose levels only), or placebo. Safety and immunogenicity were assessed through day 365 postvaccination.

Results

Overall, 140 participants received IVX-A12 (n = 117) or p

SUBMITTER: Shapiro C 

PROVIDER: S-EPMC11977332 | biostudies-literature | 2025 Apr

REPOSITORIES: biostudies-literature