OBJECTIVE: To test the safety and immunogenicity of two doses of autoclaved @entity3667 (ALM) vaccine mixed with BCG. SETTING: @entity234 endemic area of eastern Sudan. DESIGN: This was a randomised, double blind and BCG controlled phase I/II study. SUBJECTS: Eighty healthy volunteers (forty @entity1 and forty adults) with no past history of @entity234 , 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 @entity1 . 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 @entity1 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 @entity1 .

Safety and immunogenicity of an autoclaved XXXX vaccine.

@entity1 :: ('9606', 'Species') :: ['children'] @entity3667 :: ('5664', 'Species') :: ['L. major'] @entity234 :: ('MESH:D007898', 'Disease') :: ['Kala-azar', 'kala-azar']
@entity3667 :: (5664,Species) :: ['Leishmania major']
