Safety and immunogenicity of an autoclaved Leishmania major vaccine.

OBJECTIVE To test the safety and immunogenicity of two doses of autoclaved L. major (ALM) vaccine mixed with BCG. SETTING Kala-azar endemic area of eastern Sudan. DESIGN This was a randomised, double blind and BCG controlled phase I/II study. SUBJECTS Eighty healthy volunteers (forty children and forty adults) with no past history of kala-azar, no reactivity to leishmanin antigen and with a reciprocal direct agglutination test (DAT) titre of <200 were recruited. Informed consents were obtained from volunteers or their guardians in case of children. MAIN OUTCOME MEASURES Conversion in the leishmanin skin and the DAT tests. INTERVENTION Two intra-dermal injections of either ALM+BCG or BCG alone. The injections were three weeks apart. RESULTS Side effects were minimal and confined to the injection site, with no significant difference between the ALM+BCG and the BCG alone groups. The leishmanin skin conversion was significantly higher in the ALM+BCG group compared to the BCG alone group (p<0.0005). Furthermore, the Leishmanin skin test conversion was significantly higher in children than adults (p<0.0005). One adult volunteer in the ALM+BCG group converted in both the Leishmanin skin and the DAT tests. CONCLUSION We conclude that two doses of ALM+BCG are safe and immunogenic, especially in children.