Controlled field trials of a vaccine against New World cutaneous leishmaniasis.

Two controlled, double blind field trials of a non-living promastigote vaccine against New World Cutaneous Leishmaniasis (NWCL) were conducted in 1981 and 1983 in Brazil. Brazilian Army conscripts were randomly assigned to the vaccine or placebo groups and tested during their training in the Amazon jungle, a high risk area for NWCL. The results obtained showed: no significant differences between the vaccine and the placebo groups with respect to a number of characteristics (age, race, previous contact with the jungle, etc.); no significant differences between the participants who got and who did not get NWCL during the trial, with respect to length of exposure, contact with the jungle, etc. and a reduction of 67.3 and 85.7% in the annual incidence rate of NWCL, in 1981 and 1983 respectively (although the difference between incidence rates of the disease in vaccinated and control groups in the 1983 trial was not statistically significant), among those vaccinated who had converted to a positive leishmanin skin test as compared with the placebo groups.

RCT Entities:   Population Interventions Outcomes