SAFETY AND IMMUNOGENICITY OF A NATIONAL COMBINED VACCINE AGAINST PERTUSSIS, DIPHTHERIA, TETANUS, HEPATITIS B AND Hib-INFECTION, CONTAINING ACELLULAR PERTUSSIS COMPONENT, DURING IMMUNIZATION OF ADULTS
| Autor: | A V Polushkina, K A Pavroz, O Yu Sosnina, A M Nikolaeva, I V Feldblyum, T V Vyaznikova, A. E Ershov, D. M Trofimov, T V Danilina |
|---|---|
| Předmět: |
safety
Pediatrics medicine.medical_specialty 030231 tropical medicine Medicine (miscellaneous) immunization Microbiology Helsinki declaration 03 medical and health sciences 0302 clinical medicine Medicine adults aged 18-60 years 030212 general & internal medicine Seroconversion Reactogenicity business.industry Tetanus Diphtheria General Medicine Hepatitis B medicine.disease QR1-502 Vaccination Immunization Immunology business combined vaccine aapdt-hepb+hib |
| Zdroj: | Scopus-Elsevier Журнал микробиологии, эпидемиологии и иммунобиологии, Vol 0, Iss 1, Pp 46-51 (2016) |
| Popis: | Aim. Study safety, reactogenicity and immunologic effectiveness of a national combined vaccine against diphtheria, pertussis (acellular component), tetanus, hepatitis B and Hib-infection during immunization of volunteers aged 18 - 60 years. Materials and methods. The study was carried out in accordance with ethical standards and requirements, regulated by Helsinki declaration and Good clinical practice (ICHGCP). In a simple non-randomized clinical trial 20 adult volunteers took part, the mean age of those was 46.9 years. Results. Registered post-vaccination reactions (both local and systemic) were mild and of moderate degree of severity, stopped independently after 2 - 3 days without administration of drug treatment. Postvaccinal complications were not noted. Parameters of general and biochemical analysis of blood, urine, IgE content in dynamics of immunization were within normal limits. A single administration of aAPDT-HepB+Hib to individuals aged 18 - 60 years resulted in development of antibodies against all the components of the preparation. Seroconversion factor fluctuated from 6.9 to 53.5. Conclusion. The results obtained allow to recommend the vaccine for evaluation of its safety, reactogenicity, immunologic and prophylaxis effectiveness in randomized clinical observation trials in children. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|