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In 2023, protein-based respiratory syncytial virus (RSV) vaccines based on the prefusion stabilized F protein were licensed for use in older persons and pregnant women. After promising early safety and immunogenicity data, mRNA-1345 (an mRNA vaccine targeting the same antigen) is being evaluated in a randomized, placebo-controlled, manufacturer-sponsored phase 2–3 trial. The primary outcome is prevention of RSV-associated lower respiratory tract disease (LRTD) with two symptoms and LRTD with three symptoms.
A total of 35,413 participants received mRNA-1345 (17,734) or placebo (17,679); median age, 67; 49.0% female, 75.9% with fit status, 6.9% with risk factors for lower respiratory disease; median follow-up, 112 days. In a prespecified prima…