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.


METHODS
Kala-azar endemic area of eastern Sudan.


METHODS
This was a randomised, double blind and BCG controlled phase I/II study.


METHODS
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.


METHODS
Conversion in the leishmanin skin and the DAT tests.


METHODS
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.


CONCLUSIONS
We conclude that two doses of ALM+BCG are safe and immunogenic, especially in children.
Khalil
E A
EA
Leishmaniasis Research Group/Sudan, Institute of Endemic Diseases, University of Khartoum, Khartoum, Sudan.
Elhassan
A M
AM
Zijlstra
E E
EE
Osman
O F
OF
Eljack
I A
IA
Ibrahim
M E
ME
Mukhtar
M M
MM
Ghalib
H W
HW
Modabbers
F
F
D000293:Adolescent; D000328:Adult; D000368:Aged; D000818:Animals; D002648:Child; D002675:Child, Preschool; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D007125:Immunogenetics; D007223:Infant; D007891:Leishmania / Q000187:drug effects / Q000276:immunology*; D007896:Leishmaniasis / Q000276:immunology* / Q000517:prevention & control*; D054332:Leishmaniasis Vaccines; D008297:Male; D008875:Middle Aged; D016052:Protozoan Vaccines / Q000009:adverse effects* / Q000276:immunology / Q000627:therapeutic use*; D012016:Reference Values
D054332:Leishmaniasis Vaccines; D016052:Protozoan Vaccines; C416262:autoclaved Leishmania major vaccine