trial of a non-living crude vaccine against zoonotic cutaneous leishmaniasis

a field trial was canied outon60 volunteers selected in yazd province, central iran, with a vaccine containing killed promastigotes of l. major prepared by the razi institute, hessarak. during these phase i studies which lasted for more than two years, we examined acceptable doses of the vaccine alone or mixed with bcg. the results so far indicate that 50 to 1000 µg of the vaccine alone can be well tolerated without major side-effects. the mixture of bcg with 400 µg of the vaccine produced pain and itching in five out of six volunteers, a self-limiting lymphadenopathy in one out of six, and fever in three out of six. further trials are planned with reduced doses of bcg. the leishmania skin test became positive in a high proportion of the treated individuals after vaccination. circulating antibodies were detected from two weeks to one month after vaccination.