In order to validate two new lots of Mérieux BCG vaccine (Mérieux seed derived from strain 1072), a calibration study was performed to compare their safety and immunogenicity to a full dose of the WHO-reference BCG vaccine (Tokyo strain 172) as well as the WHO-reference vaccine given at 1/10 of its normal concentration, in an open, randomized, four-arm, multicenter study in Senegal.
A total of 1041 healthy Senegalese children aged 8-10 years were screened for participation in this study, of whom 548 had a negative Mantoux test and complied with inclusion and exclusion criteria.
These children were randomly allocated a single dose of one of the following vaccines :
full-dose Mérieux BCG vaccine (lot E0650) ;
full-dose Mérieux BCG vaccine (lot E0624) ;
full-dose WHO-reference vaccine (Tokyo strain 172) : or 1/10 dose WHO-reference vaccine.
A follow-up examination, including a tuberculin test, was performed 10-12 weeks after BCG vaccination for 465 (85%) children : 236 Mérieux BCG vaccine (117 lot E0650 ; 119 lot E0624) : 115 full-dose WHO : 1141/10 dose WHO.
The percentage of subjects with a positive tuberculin test after vaccination was significantly lower (p<0.001) in the 1/10 dose group (81.5%) compared to the other three groups (>96%). (...)
Mots-clés Pascal : Mycobacterium bovis, Mycobacteriaceae, Mycobacteriales, Actinomycetes, Bactérie, BCG, Enfant, Homme, Vaccin, Vaccination, Programme sanitaire, Immunogénicité, Immunoprotection, Toxicité, Etude comparative, Tuberculose, Mycobactériose, Bactériose, Infection, Sénégal, Afrique, Afrique Ouest
Mots-clés Pascal anglais : Mycobacterium bovis, Mycobacteriaceae, Mycobacteriales, Actinomycetes, Bacteria, BCG, Child, Human, Vaccine, Vaccination, Sanitary program, Immunogenicity, Immunoprotection, Toxicity, Comparative study, Tuberculosis, Mycobacterial infection, Bacteriosis, Infection, Senegal, Africa, West Africa
Notice produite par :
Inist-CNRS - Institut de l'Information Scientifique et Technique
Cote : 99-0145704
Code Inist : 002B05A02. Création : 16/11/1999.