DEVELOPMENT AND STANDARDIZATION OF FROZEN-DRIED VACCINE FORM FOR PREVENTION OF HAEMOPHILUS INFLUENZAE TYPE B-INDUCED INFECTIONS

Aim. To produce a frozen-dried vaccine form for prevention of infections induced by Haemophilus influenza of type b (HIB-vaccine), its standardization and preclinical assessment. Materials and methods. HIB-vaccine quality was estimated by the following parameters: quantitative determination of polyribosilribitol phosphate (PRP), solubility, drying mass loss, sterility, osmolarity, immunogenicity. Preclinical assessment of HIB-vaccine safety was performed on outbred white mice using standard methods including the study of acute and chronic toxicity, pathomorphological, hematological and biochemical investigations. Results. Technology of producing a frozen-dried drug form of HIB-vaccine was developed. To determine the identity of HIB-vaccine titanic component, an original method based on coagglutination reaction was offered. It was shown that a frozen-dried HIB-vaccine stimulates production of PRP antibodies in rabbits at the level comparable with AKT-HIB and Kimi-HIB vaccines (16,91, 17,19 and 15,28 mkg/ml, respectively). When using AKDS-Hep V+HIB and aAKDS-Hep V+HIB vaccines, a higher level of antibodies to polysaccharide (42,91 and 40,31 mkg/ml), respectively) as compared to monovaccines ( p <0,05) was observed. While studying HIB-vaccines in the tests of acute and chronic toxicity, no decrease in animal body mass as well as essential changes in biochemical and hematological indices was stated that proves absence of toxic effects of the drug. Conclusion. The studied physiochemical properties, sterility, identity, immunogenicity and specific safety showed that a frozen-dried form of synthetic conjugated vaccine for prevention of type b hemophilic infection, produced by the developed technology, completely corresponds to the requirements of European Pharmacopeia and can be used as a component of combined vaccines for prevention of diphtheria, tetanus, whooping cough, hepatitis B and hemophilic infection of type b .

Type b hemophilic infection, HIB-vaccine, osmolarity, stability, polyribosilribitol phosphate (PRP), preclinical studies, acute toxicity, immunogenicity