Publication date: Dec 04, 2024

Background: Different platforms were used to develop vaccines against SARS-CoV-2 which were instrumental in bringing an end to the pandemic. Nevertheless, long term efficacy and safety profiles of the various vaccine types is still being investigated. The current trial aimed to assess the safety and immunogenicity of the Gam-COVID-Vac combined vector vaccine against SARS-CoV-2-induced coronavirus infection up to 6 months post vaccination. Methods: In this randomized, double-blind, placebo-controlled trial, study participants 18 (or older) years of age with no prior SARS-COV-2 infection or vaccination were randomized (3:1) to receive the heterologous recombinant human adenovirus-vectored vaccines serotypes 26 and 5 or placebo. Immunogenicity was determined based on quantitative IgG antibodies (Abs) to viral S and N proteins, virus-neutralizing Abs (VNA), seroconversion rates, and S protein-specific CD4 and CD8 T cell responses. Results: A total of 990 participants were randomized to the vaccine (n=74) and placebo (n=246) groups. Overall incidence of Adverse events (AEs) was 1844 (81.5%) in the vaccine and 501 in placebo (82.1%) groups, the majority being in the mild/moderate categories. Two doses of vaccine induced VNA in 100% of participants on Day 42, with geometric mean ratio (GMR) reaching maximum at 120 days with average 24.14 (p

PDF

Semantics

Download Document