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AERAS-402 is a replication-deficient recombinant adenovirus serotype 35 (Ad35) vector vaccine that encodes a fusion protein of three major Mycobacterium tuberculosis antigens: Ag85A, Ag85B, and TB10.4. These antigens are designed to induce both CD4+ and CD8+ T cell responses against M. tuberculosis. The vaccine aims to boost cellular immunity in the lung, the primary site of TB infection, by generating robust antigen-specific T cell responses. It has been evaluated as a prophylactic vaccine for tuberculosis in both animal models and human clinical trials, including studies using intramuscular and aerosol administration routes[1][2][5]. Developed primarily by Aeras (now part of IAVI), it has reached up to Phase 2 clinical trials for tuberculosis prevention but is not approved for use in any country[3][4].
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