Evaluation of a mosaic HIV 1 vaccine in a multicentre randomised double blind placebo controlled phase 1 2a clinical trial APPROACH and in rhesus monkeys.

Journal Abstract: This phase I/IIa clinical trial evaluated the safety and immunogenicity of adenovirus serotype 26 (Ad26) vector-based HIV-1 vaccine regimens in 393 participants across multiple regions. Results demonstrated that all vaccine regimens were well-tolerated, with the mosaic Ad26 prime/Ad26+gp140 boost regimen showing the strongest immunogenic response, eliciting significant antibody and T-cell responses. A parallel study in rhesus monkeys confirmed the vaccine's potential for protective efficacy, providing critical insights for the development of an HIV-1 vaccine.