Titre and safety of rotavirus master seed G1P8 (KH0118)

ABSTRACT

Background: Rotavirus vaccines used to prevent acute diarrhea among children under 5 years old. In Vietnam, with the assistance of the World Health Organization (WHO), Centers for disease control and prevention (CDC), Atlanta, United States, Ministry of Health and Ministry of science and technology researched to create rotavirus master seed G1P8 which would use to produce Rota virus in Vietnam. Objectives: to evaluate titre and safety of rotavirus master seed G1P8 in vitro and in experimental animals. Subjectives and Method: experimental studies in vitro and experimental animals. Rotavirus master seed G1P8 (KH0118) series 1 (MS-P5) and series 2 (MS-P5) produced in 2005, preserved 80oC, were determined by immunofluorescence method (with unit of FFU/ml). The strains were tested in experimental animal\u2019s safety like the safe requirements of World Health Organization on live-attenuated vaccine (OPV). Results: no detection for exotic virus strains in virus suspension by PCR and titres of rotavirus master seed were similar and were more than 107 FFU / ml. 10 intervened rabbits were healthy life during follow up period, 8/10 these rabbits increased weight after follow up period, only two rabbits reduced weight but increase of mean weight of all 10 rabbits was 106%. 5 intervened guinea-pig increased mean weight (158%) and healthy during follow-up period. 4 experimental white mice increased mean weight (195%), higher than control groups. It was safety in experimenting on baby mice. Conclusions: two lots of rotavirus master seed G1P8 produced in POLYVAC had high titre and safety both in vitro and in experimental animals.