The safety and immune response of rotavirus master seeds in monkeys

ABSTRACT

Background: Group A Rotavirus is the main cause of diarrhea in human especially in children under 5 years old. Rotavirus master seeds were established from group A Rotavirus (mainly 3 strains: G1P8, G1P4 and G4P6) causing acute diarrhea for children in Vietnam. The master seeds must meet the potency and safety in the laboratory as well as animal experiments under the guidance of WHO. Objectives: To determine the safety and immune response of rotavirus master seeds in monkeys to confirm their safety and effect in preclinical stage. Subjects and method: Baby Macacca mulatta monkeys had average weight of 1.5 kg (provided by monkey ranch in Reu island in Quang Ninh province) were tested and determined neutral antibody by immunofluorescence technique. Results: The rotavirus master seeds: G1P8 (KH0118); G1P4 (2001019210) and G4P6 (2001019203) had good safety and immune response with high neutral antibody after 3 dose vaccination in baby Macacca mulatta monkeys. Conclusion: The rotavirus master seeds would be a base for diarrhea vaccine production in Viet Nam under the guidance of the World Health Organization.