02294nas a2200289   4500000000100000008004100001260001200042100001200054700001800066700001900084700001500103700001600118700002200134700001600156700001300172700002000185700001700205700001700222700001700239700001300256700001700269245005400286300001200340490000700352520163100359022001401990       1998                            d  c01/19981 aGupte M1 aVallishayee R1 aAnantharaman D1 aNagaraju B1 aSreevatsa S1 aBalasubramanyam S1 ade Britto R1 aElango N1 aUthayakumaran N1 aMahalingam V1 aLourdusamy G1 aRamalingam A1 aKannan S1 aArokiasamy J00aComparative leprosy vaccine trial in south India.  a369-3880 v703 a<p>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.</p>
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