A 2-Dose AERAS-402 Regimen Boosts CD8⁺ Polyfunctionality in HIV-Negative, BCG-Vaccinated Recipients.

ABSTRACT: Despite the widespread use of BCG, tuberculosis (TB) remains a global threat. Existing vaccine candidates in clinical trials are designed to replace or boost BCG which does not provide satisfying long-term protection. AERAS-402 is a replication-deficient Ad35 vaccine encoding a fusion protein of the M. tuberculosis (Mtb) antigens 85A, 85B, and TB10.4. The present phase I trial assessed the safety and immunogenicity of AERAS-402 in participants living in India - a highly TB-endemic area. Healthy male participants aged 18-45 years with a negative QuantiFERON-TB Gold in-tube test (QFT) were recruited. Enrolled participants (n=12) were randomized 2:1 to receive two intramuscular injections of either AERAS-402 (3 x 10¹⁰ viral particles [vp]); (n=8) or placebo (n=4) on study da

SUBMITTER: Sivakumaran D 

PROVIDER: S-EPMC8231292 | biostudies-literature | 2021

REPOSITORIES: biostudies-literature