Safety and potency of rotavirus master seed G4P6 (2001019203)

ABSTRACT

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.