Safety and potency of rotavirus master seed G4P6 (2001019203)

Background: Rota vaccine is used to prevent diarrhea in children under 5 years old. Two vaccines are being used in developed countries: Rotarix (GSK) and RotaTeq (Merk). Rotarix vaccine was produced from master seed G1P8 and RotaTeq vaccine was from the coordination of human rotavirus strains G1, G2, G3, G4 and cow rotavirus strain. Thanks to the help of WHO, Ministry of Health and Ministry of Science and Technology, Center for research and production of vaccines and biologicals \ufffd?Ha Noi made study of creating rotavirus master seed G4P6 for Rota vaccine production in Vietnam. Objectives: To evaluate the safety and potency of rotavirus master seed G4P6 in the laboratory and experimental animals. Subjects and method: Rotavirus master seed G4P6 (2001019203) lot 1 (MS-PL5) and lot 2 (MS-PL5) produced in 2005, preserved at -800C were determined potency by Immunofluorescence (IF) method and tested for safety on rabits and rats. Results:2 lots of Rotavirus master seed G4P6 that had been produced in Center for research and production of vaccines and biologicals \ufffd?Ha Noi had high titre and safety in the laboratory and experimental animals. Conclusion: The results were the basis of Rota vaccine production in Vietnam.

Titre and safety of rotavirus master seed G1P8 (KH0118)

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.

Safety and potency of rotavirus master seed G1P4 (2001019210)

Background: Rota vaccine is used to prevent diarrhea in children under 5 years old. Two vaccines are being used in developed countries: Rotarix (GSK) and RotaTeq (Merk). Rotarix vaccine was produced from master seed G1P8 and RotaTeq vaccine was from the coordination of human rotavirus strains G1, G2, G3, G4 and cow rotavirus strain.Thanks to the helps of WHO, Ministry of Health and Ministry of Science and Technology, Center for research and production of vaccines and biologicals \ufffd?Ha Noi made study of creating rotavirus master seed G1P4 for Rota vaccine production in Vietnam. Objectives: To evaluate the safety and potency of rotavirus master seed G1P4 in the laboratory and experimental animals. Subjects and method: Rotavirus master seed G1P4 (2001019210) lot 1 (MS-P5) and lot 2 (MS-P5) produced in 2005, preserved at -800C were determined potency by Immunofluorescence (IF) method and tested for safety on rabits and rats. Results:2 lots of Rotavirus master seed G1P4 that had been produced in Center for research and production of vaccines and biologicals \ufffd?Ha Noi had high titre and safety in the laboratory and experimental animals. Conclusion: The result was the basis of Rota vaccine production in Vietnam.