Trial of non-living crude vaccine against zoonotic cutaneous leishmaniasis

ABSTRACT

A field trial was carried out on 60 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 micro g of the vaccine alone can be well tolerated without major side-effects. The mixture of BCG with 400 micro g 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