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 o