Reactogenicity, safety and immonogenicity of a recombinant bivaccine againstsmallpox and hepatitis В in limited clinical trials
- Issue: Vol 49, No 5 (2004)
- Pages: 22-26
- Section: Articles
- Submitted: 09.06.2023
- Published: 15.10.2004
- URL: https://virusjour.crie.ru/jour/article/view/11869
- ID: 11869
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Abstract
The reactogenicity of the embryonic live recombinant variola and hepatitis В bivaccine as tablets (Revax-BT) as
well as its safety and immunogenicity were evaluated in clinical trials made in volunteers who had previously immunized
or not with variola vaccine. A preliminary conclusion was made on a lack of side effects and drug safety
in primary vaccination and been revaccination with low and high doses. Primary immunization of volunteers and
as bivaccination with high doses stimulated the most pronounced immune response to the vaccine virus versus
such effect observed in immunization of volunteers with low vaccine doses. Humoral immune response to HBs
was observed in 75% of volunteers of both groups after as bivaccination. Such response was most pronounced
in examinees immunized with low vaccine doses versus those who received high bivaccine doses. At the same
time, no protective levels of humoral immunity response to HBs Ag were observed in volunteers first vaccinated.
well as its safety and immunogenicity were evaluated in clinical trials made in volunteers who had previously immunized
or not with variola vaccine. A preliminary conclusion was made on a lack of side effects and drug safety
in primary vaccination and been revaccination with low and high doses. Primary immunization of volunteers and
as bivaccination with high doses stimulated the most pronounced immune response to the vaccine virus versus
such effect observed in immunization of volunteers with low vaccine doses. Humoral immune response to HBs
was observed in 75% of volunteers of both groups after as bivaccination. Such response was most pronounced
in examinees immunized with low vaccine doses versus those who received high bivaccine doses. At the same
time, no protective levels of humoral immunity response to HBs Ag were observed in volunteers first vaccinated.
References
- Ашмарин И. П., Воробьев А. А. Статистические методы в микробиологических исследованиях. - Л., 1962.
- Маренникова С. С., Щелкунов С. Н. Патогенные для человека ортопоксвирусы. - 1998.
- Методы оценки клеточных эффекторных функций гиперчувствительности замедленного типа: Метод, рекомендации. - М., 1990.
- Нетесова И. Г. Субтип HBsAg как одна из характеристик инфекции гепатита В у различных групп населения Западной Сибири: Дис. ... канд. биол. наук. - Кольцове, 2002.
- Онищенко Г. Г., Сандахчиев Л. С., Нетесов С. В., Щелкунов С. В. Биотерроризм как национальная и глобальная угроза // Журн. микробиол. - 2000. - № 6. - С. 83-85.
- Пат. 1575576 РФ. Рекомбинантная плазмидная ДНК р7,5 S2-S, содержащая pre-S2-S ген вируса гепатита В, способ ее конструирования и штамм рекомбинантного вируса осповакцины, экспрессирующий pre-S2-S ген вируса гепатита В // Беляев А. С., Путинцева Н. И., Дмитриев И. П. и др. - Заявка № 4445111 от 20.06.88.
- Пат. 2076735 РФ. МПК А 61 К 39/00. Живая рекомбинантная вакцина гепатита В на основе вируса осповакцины для перорального применения и способ ее получения // Муратов П. Ю., Сандахчиев Л. С., Дмитриев И. П. и др. Патентообладатель ГНЦ ВБ "Вектор". - Приоритет 23.03.94 г. Опубл. 10.04.97.
- Справочник по микробиологическим и вирусологическим методам исследования / Под ред. М. О. Биргера. - М., 1967. - С. 105; 171.
- Bulkr R. M. L., Smith G. L., Gemer К. et al. Decreased viru- lence of recombinant vaccine virus expression vectors is associated with a thymidinekinase negative phenotype // Nature. - 1985. - Vol. 317, N 6040. - P. 813-815.
- Fenner F., Henderson D. A., Arita I. et al. Smallpox and Its Eradication. - Geneva, 1988.
- Frey S. E., Couch R. В., Tacket С. О. et al. Clinical responses to undiluted and diluted smallpox vaccine // N. Engl. J. Med. - 2002. - Vol. 346, N 17. - P. 1265-1274.
- Henderson D. A. The looming threat of bioterrorism // Science. -1999. - Vol. 283. - P. 1279-1282.
- Jahrling P. B. Production of Cell Culture and Alternative Vaccines for Smallpox Immunization. - WHO, 1999.