Safety and immunogenicity of UB-612 heterologous booster in adults primed with mRNA, adenovirus, or inactivated COVID-19 vaccines: a randomized, active-controlled, Phase 3 trial.

ABSTRACT:

Background

Authorized COVID-19 vaccines require boosters for continued protection; however, the lack of cross-platform compatible boosters creates practical challenges to keeping populations protected.

Methods

This Phase 3, multicenter, international, randomized, active-controlled trial compared UB-612 as a third-dose heterologous booster to BNT162b2, ChAdOx1-S, or BBIBP-CorV homologous boosters in healthy subjects aged ≥16 years. Participants were randomly assigned 1:1 to receive a single intramuscular injection of UB-612 or an active comparator matching the primary dose, and were stratified for age, sex, N-protein seropositivity, and time since the last dose of their primary series COVID-19 vaccination. The primary objective was to show non-inferiority of neutralizing anti

SUBMITTER: Rumyantsev A 

PROVIDER: S-EPMC12301762 | biostudies-literature | 2025 Aug

REPOSITORIES: biostudies-literature