Daniel F Hoft, Azra Blazevic, Asmir Selimovic, Aldin Turan, Jan Tennant, Getahun Abate, John Fulkerson, Daniel E Zak, Robert Walker, Bruce McClain, Jerry Sadoff, Judy Scott, Barbara Shepherd, Jasur Ishmukhamedov, David A Hokey, Veerabadran Dheenadhayalan, Smitha Shankar, Lynn Amon, Garnet Navarro, Rebecca Podyminogin, Alan Aderem, Lew Barker, Michael Brennan, Robert S Wallis, Anne A Gershon, Michael D Gershon, Sharon Steinberg
BACKGROUND: We report a first-in-human trial evaluating safety and immunogenicity of a recombinant BCG, AERAS-422, over-expressing TB antigens Ag85A, Ag85B, and Rv3407 and expressing mutant perfringolysin. METHODS: This was a randomized, double-blind, dose-escalation trial in HIV-negative, healthy adult, BCG-naïve volunteers, negative for prior exposure to Mtb, at one US clinical site. Volunteers were randomized 2:1 at each dose level to receive a single intradermal dose of AERAS-422 (>10(5)-<10(6)CFU=low dose, ≥10(6)-<10(7)CFU=high dose) or non-recombinant Tice BCG (1-8×10(5)CFU)...
May 2016: EBioMedicine