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  • Title: Safety and immunogenicity of an autoclaved Leishmania major vaccine.
    Author: Khalil EA, Elhassan AM, Zijlstra EE, Osman OF, Eljack IA, Ibrahim ME, Mukhtar MM, Ghalib HW, Modabbers F.
    Journal: East Afr Med J; 2000 Sep; 77(9):468-70. PubMed ID: 12862135.
    Abstract:
    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.
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