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Updated: Sep 23, 2026
Deciphering the Molecular Mechanism and Function of Pore-Forming Toxins Using Leishmania major
Published on: October 28, 2022
Safety and immunogenicity of an autoclaved Leishmania major vaccine
E A Khalil1, A M Elhassan, E E Zijlstra
1Leishmaniasis Research Group/Sudan, Institute of Endemic Diseases, University of Khartoum, Khartoum, Sudan.
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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