South Indian leprosy vaccine trial: important lessons for mycobacterial immunology
1999; British Leprosy Relief Association; Volume: 70; Issue: 3 Linguagem: Inglês
10.5935/0305-7518.19990026
ISSN2162-8807
Autores Tópico(s)Mycobacterium research and diagnosis
Resumo171,400 individuals living in Chingleput District, South India, were recruited into a major leprosy vaccine trial organized by the Indian Council for Medical Research.The participants were randomized to receive a placebo, a plain BCG vaccine, a combination of BCG plus killed leprosy bacilli, or else a killed environmental mycobacterial vaccine: either 'Mycobacterium W', or 'Mycobacterium ICRC'.Eighty-five percent of these individuals were examined for leprosy between August 1993 and February 1995 and 75% were examined between January 1997 and September 1998.The codes were broken in December 1998, and revealed that each of the vaccines had provided significant protection over the interval between 4 and 8 years after vaccination: 65 .5% for the ICRC bacillus, 64% for combined BCG and killed My cobacterium leprae, 34% for BCG alone and 25•7% for the W bacillus.l These figures, and the data behind them, include several findings of considerable importance for research on mycobacterial immunology and vaccines.In the first follow-up survey (up to 4 years after vaccination), the incidence of leprosy was higher among each of the active vaccine groups, compared to the placebo recipients.Though these differences were not individually statistically significant, the result is consistent with similar patterns seen in the initial follow up in a leprosy vaccine trial in Burma, 2 and a tuberculosis vaccine trial in South India.3 , 4 This finding provides important further evidence that antigenic challenge can accelerate progression to mycobacterial disease among individuals
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