Boosting BCG with proteins or rAd5 does not enhance protection against tuberculosis in rhesus macaques

Study design. A total of 64 rhesus macaques were enrolled into three challenge cohorts (A/B, n？=？20 each; C, n？=？24) and eight experimental groups: unvaccinated (No Vax, n？=？8 in Cohort A/B and n？=？4 in Cohort C presented separately because of differences in sampling schedules between cohorts); BCG-primed (BCG, n？=？8); BCG-primed and boosted IM/AE 20 or 25 weeks later with either an empty Ad5 vector [Ad5(Empty), n？=？7], Ad5 expressing ESAT-6 and Ag85B [Ad5(EB), n？=？8]; Ad5 expressing M72 [Ad5(M72), n？=？8]; or Ad5 expressing ESAT-6, Rv1733, Rv2626, and RpfD [Ad5(4Ag), n？=？7]; BCG-primed and boosted IM twice (4 or 5 weeks apart) 16–25 weeks later with either M72 protein or H56 protein in adjuvant (M72/AS01E, n？=？8 or H56:CAF01, n？=？6). Three months after boosting (32–38 weeks after BCG), macaques were challenged with a low dose of Mtb Erdman (8–16 CFU) and monitored for 6 months post challenge (study endpoint