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  1. Comparison of the safety and immunogenicity of the lyophilized Mérieux seed and the World Health Organization working reference BCG vaccines in school-aged children in Senegal.

    Article - En anglais

    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

    Logo du centre Notice produite par :
    Inist-CNRS - Institut de l'Information Scientifique et Technique

    Cote : 99-0145704

    Code Inist : 002B05A02. Création : 16/11/1999.