Immunogenicity and Safety of Heterologous Versus Homologous Prime-Boost Regimens With BBIBP-CorV and Ad26.COV2.S COVID-19 Vaccines: A Multicentric, Randomized, Observer-Blinded Non-inferiority Trial in Madagascar and Mozambique.

ABSTRACT:

Background

Data on immunogenicity and safety of heterologous prime-boost (HePB) regimens using the BBIBP-CorV and Ad26.COV2.S have not yet been reported in sub-Saharan Africa.

Methods

We conducted a randomized, observer-blinded, non-inferiority trial assessing the immunogenicity and safety of HePB regimens using BBIBP-CorV and Ad26.COV2.S, in adults aged 18-65 years. Participants enrolled, were stratified by baseline severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) serostatus, and randomized into four arms in a 1:1:1:1 ratio: A1 (BBIBP-CorV, Ad26.COV2.S), A2 (BBIBP-CorV, BBIBP-CorV), B1 (Ad26.COV2.S, BBIBP-CorV), and B2 (placebo, Ad26.COV2.S), administered at 28-day intervals. Fifteen participants in each arm were randomized separately in the immunology subset at

SUBMITTER: Ramgi P 

PROVIDER: S-EPMC12282515 | biostudies-literature | 2025 Jul

REPOSITORIES: biostudies-literature