This report provides results from a controlled, double blind, randomized, prophylactic
leprosy vaccine trial conducted in South India. Four
vaccines, viz BCG, BCG+ killed M. leprae, M.w and ICRC were studied in this trial in comparison with
normal saline placebo. From about 3,00,000 people, 2,16,000 were found eligible for vaccination and among them, 1,71,400 volunteered to participate in the study. Intake for the study was completed in two and a half years from January 1991. There was no instance of serious toxicity or side effects subsequent to vaccination for which premature decoding was required. All the
vaccine candidates were safe for human use. Decoding was done after the completion of the second resurvey in December 1998. Results for
vaccine efficacy are based on examination of more than 70% of the original "vaccinated" cohort population, in both the first and the second resurveys. It was possible to assess the overall protective efficacy of the candidate
vaccines against
leprosy as such. Observed incidence rates were not sufficiently high to ascertain the protective efficacy of the candidate
vaccines against progressive and serious forms of
leprosy. BCG+ killed M. leprae provided 64% protection (CI 50.4-73.9), ICRC provided 65.5% protection (CI 48.0-77.0), M.w gave 25.7% protection (CI 1.9-43.8) and BCG gave 34.1% protection (CI 13.5-49.8). Protection observed with the ICRC
vaccine and the combination
vaccine (BCG+ killed M. leprae) meets the requirement of public health utility and these
vaccines deserve further consideration for their ultimate applicability in
leprosy prevention.