Safety and immunogenicity of Ad26.COV2.S in adolescents: Phase 2 randomized clinical trial.

ABSTRACT: We conducted a randomized, Phase 2 trial to assess the safety and humoral immunogenicity of reduced doses/dose volume of the standard dose of Ad26.COV2.S COVID-19 vaccine (5 × 10¹⁰ viral particles [vp]) in healthy adolescents aged 12-17 years. Participants were randomly assigned to receive Ad26.COV2.S at reduced dose levels of 0.625 × 10¹⁰ (0.5 mL), 1.25 × 10¹⁰ (0.5 mL) or 2.5 × 10¹⁰ (0.5 mL or low volume 0.25 mL) vp in a 1- or 2-dose (56-day interval) primary schedule. Adolescents who received a 1-dose primary schedule received a 2.5 × 10¹⁰ vp booster dose 6 months later. Safety and humoral immunogenicity were assessed up to 6 months post-last vaccination. All regimens were well tolerated, with no safety concerns identified. Local and

SUBMITTER: Tica J 

PROVIDER: S-EPMC11776467 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature