Table 1. Summary of clinical trials to identify novel vaccines for leprosy.

	vaccine	location	overall study size	study follow-up (years)	% protection	reference
	BCG BCG + killed M. leprae	Venezuela	29, 113	5	56 54	58
	BCG BCG + killed M. leprae	Malawi	121, 020	6–9	49 49	59
Whole bacteria	BCG BCG + killed M. leprae M. w ICRC	India	171, 400	4–7	34 64 26 66	61
	M. w (killed)	India	29, 420	8–10	39	64
	BCG M. vaccae BCG + M. vaccae	Vietnam	432	8	58 55 66	65
	BCG	composite of multiple studies (meta-analysis)			26–41a (experimental) 61 (observational)	50 , 51
Sub-unit	None reported

^a Setia and colleagues selected all the studies (experimental and observational) that described the efficacy of BCG with prevention of clinical leprosy (defined according to clinical and/or microscopic criteria) and excluded studies that measured the protective effect of BCG combined with other therapies (eg, chemotherapy, killed M leprae)/ Their meta-analysis was restricted to studies that measured the protective effect of BCG alone. Merle and colleagues selected only controlled trials with a clearly defined placebo (or nonintervention) group. To be included in their analysis, case-control studies had to define the criteria for selecting cases and controls, as well as the method for determining their BCG vaccination status.