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Information × Registration Number 0217U006188, 0114U000246 , R & D reports Title C.diphtheriae surface antigens combined with diphtheria toxoid immunogenicity and double-testing methods of thier safety popup.stage_title Head Babich Evgenij Mihajlovich, Доктор технічних наук Registration Date 27-02-2017 Organization The Mechnikov Research Institute of microbiology and immunology at Kharciv popup.description2 The object of study: the production strain C. diphtheriae gravis, tox +, massachussets, the museum strain of C. diphtheriae № 255 gravis, tox +, the circulating strain of C. diphtheriae gravis, tox +, new, surface antigens of microbial cells C. diphtheriae, native purified concentrated diphtheria toxoid, diphtheria complex experimental vaccine candidates, electro-magnetic radiation of extremely high frequency, ultrasonic irradiation. The purpose of research: a scientific ground for developing of a new class of vaccine candidates, aimed at limiting of the colonization process of respiratory tract mucous membranes by pathogenic corynebacteria with a simultaneous prevention of diphtheria disease and experimental study of ways to increasing of the safety control efficiency of the antigenic complexes under study. Methods: microbiological, physical and chemical, immunological. Equipment: electromagnetic radiation generator with a frequency of 61 GHz, the mean frequency ultrasound source. Theoretical and practical results: It's shown the principal possibility of the development of efficient and safe complex diphtheria candidate vaccines based on native purified diphtheria toxoid and diphtheria bacterial antigenic preparations obtained using physical factors in laboratory and production environments. Adjuvant effect of bacterial antigenic components validated in various schemes of immunization of test animals, which gives reason to consider them as candidates for adjuvants that can replace aluminum hydroxide. It was found that the adjuvant effect of the antigenic preparations retained during a long-term storage. Immunization by bacterial diphtheria antigen prevents colonization of respiratory tract mucous membranes of test animals by diphtheria pathogen. An anticolonization activity of the immunization was stronger in the bacterial antigen complex with purified diphtheria toxoid. Reactogenicity of study antigenic preparations was determined by the degree of purification of the antigenic preparations and the concentration of protein in them. In connection with the emergence, in some cases, remote skin reactions to the introduction of candidate vaccines, it is advisable to extend the regulated four days period of observation. Determination of glucose utilization activity of C.diphtheriae culture can be used as an additional method for monitoring of the state of culture media and production culture. It was found that by using fluorimetry can be screened samples of diphtheria toxoid to determine its quality deviations. Novelty: scientific approaches to development of a combined candidate vaccines based on the use of C. diphtheriae surface antigens as adjuvant, adhesive and protective components in combination with diphtheria toxoid and additional methods of assessment of the safety and the quality of vaccine candidates. The effectiveness of implementation: improving of the efficiency of diphtheria vaccines due to the introduction in their structure of the bacterial antigen, which should support the formation of humoral immunity and possess anti colonization action against diphtheria. Scope: medical microbiology, vaccinal prevention, the development of anti-diphtheria vaccines. Product Description popup.authors Єлисеєва Ірина Віталіївна Ісаєнко Олена Юріївна Білозерський Володимир Іванович Бірюкова Світлана Василіївна Бабич Євгеній Михайлович Ждамарова Лариса Анатоліївна Колпак Світлана Анатоліївна Савінова Олена Михаліївна popup.nrat_date 2020-04-02 Close