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 s
tudy.
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 or < 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. T
he 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. Th
e leishmanin skin conversion was significantly higher in the ALM+BCG group
compared to the BCG alone group (p <0.0005). Furthermore, the Leishmanin sk
in test conversion was significantly higher in children than adults (p <0.0
005). One adult volunteer in the ALM+BCG group converted in both the Leishm
anin skin and the DAT tests.
Conclusion: We conclude that two doses of ALM+BCG are safe and immunogenic,
especially in children.