title: Viability, heat stability and immunogenicity of four BCG vaccines prepared from four different BCG strains.
abstract: Four BCG strains, French 1173-P2, Danish 1331, Japanese 172 and Glaxo-1077, among those most widely used throughout the world for tuberculosis vaccination, were prepared according to the respective conditions in each BCG-production unit. These 16 vaccine preparations were distributed and compared using standardized in vitro and in vivo conditions, based on optical density and bacillary mass/ml. The results presented in this report concern only the 4 freeze-dried BCG strains prepared by the Institut Pasteur BCG unit. It is shown that these 4 preparations differ in their in vitro characteristics such as growth, morphology, heat stability and viability, tested by colony-forming units and the ATP content. In addition, statistically significant differences were observed in biological control tests performed in guinea-pigs and mice when they were immunized with the same concentrations of 4 reconstituted vaccines. For instance, in tests measuring hallmarks of cell-mediated immunity--such as local granuloma formation, spleen index, delayed-type hypersensitivity to tuberculin, and non-specific immunopotentiation to unrelated antigen--a ranking order of relative immunopotency of the four strains was made, giving the following classification in decreasing order: French 1173-P2, Danish 1331, Japanese 172 and Glaxo-1077. Specific acquired resistance after BCG vaccination in mice was obtained with all four vaccines. However, higher protection was observed in mice vaccinated with Glaxo-1077 and French 1173-P2 strains. No obvious correlation existed between the intensity of cellular post-vaccination resistance and the above CMI tests, except those concerning the three-week index of BCG infection measured in the spleen, which correlated with the protection test.
mesh_terms: D000255:Adenosine Triphosphate / Q000032:analysis; D000818:Animals; D001500:BCG Vaccine / Q000032:analysis / Q000276:immunology*; D005260:Female; D006099:Granuloma / Q000209:etiology; D006168:Guinea Pigs; D006358:Hot Temperature; D006968:Hypersensitivity, Delayed; D007110:Immunity, Active; D007113:Immunity, Innate; D008214:Lymphocytes / Q000276:immunology; D008297:Male; D051379:Mice; D009163:Mycobacterium bovis / Q000166:cytology / Q000254:growth & development; D013045:Species Specificity; D013154:Spleen / Q000276:immunology; D014376:Tuberculosis / Q000276:immunology*; D014611:Vaccination
chemical_list: D001500:BCG Vaccine; D000255:Adenosine Triphosphate