关键词: 季节性流感病毒, 裂解疫苗, 动物实验, 安全性, 免疫原性

Abstract: Objective To evaluate the safety and immunogenicity of split seasonal influenza vaccine in BALB / c mice. Method The toxicity test was performed according to the requirements in Chinese Pharmacopoeia( Volume Ⅲ ,2015 edition) . For immunogenicity, BALB / c mice were divided into two groups randomly. The mice in test group were immunized with split vaccine at a dosage of 0. 1 mL intramuscularly, and those in negative control group with PBS. The mice were monitored daily for their activities, diet and weight up to day 49 post- immunization. Sera were harvested from the mice on day 0, 14, 28, 35 and 49 for seroconversion confirmation using hemagglutination inhibition ( HI ) assays. Result Our toxicity test results were consistent with the requirements in Chinese Pharmacopoeia( Volume Ⅲ , 2015 edition) ,and the vaccine was safe and had no effect on the growth of mice. The HI antibody of 100% antisera raised against A( H1N1) pam09 and A( H3N2) were positive after immunization 28 days, and 70% antisera raised against B ( Victoria lineage ) were positive after immunization 35 days. The concentration of the antibodies reached the peak after immunization 35 days. Our result indicated that the tested vaccine could elicited antibodies against A ( H1N1 ) pam09, A ( H3N2 ) and B ( Victoria lineage ) by first immunization. Conclusion The split seasonal influenza vaccine was safe and efficacious in BALB / c mice.

Key words: Seasonal Influenza virus, Split vaccine, animal experiment, safety, immunogenicity