title: Safety and immunogenicity of an autoclaved Leishmania major vaccine.
abstract: 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.
authors.affiliation: Leishmaniasis Research Group/Sudan, Institute of Endemic Diseases, University of Khartoum, Khartoum, Sudan.
authors.forename: E A
authors.initials: EA
authors.lastname: Khalil
authors.forename: A M
authors.initials: AM
authors.lastname: Elhassan
authors.forename: E E
authors.initials: EE
authors.lastname: Zijlstra
authors.forename: O F
authors.initials: OF
authors.lastname: Osman
authors.forename: I A
authors.initials: IA
authors.lastname: Eljack
authors.forename: M E
authors.initials: ME
authors.lastname: Ibrahim
authors.forename: M M
authors.initials: MM
authors.lastname: Mukhtar
authors.forename: H W
authors.initials: HW
authors.lastname: Ghalib
authors.forename: F
authors.initials: F
authors.lastname: Modabbers
mesh_terms: 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
chemical_list: D054332:Leishmaniasis Vaccines; D016052:Protozoan Vaccines; C416262:autoclaved Leishmania major vaccine