Abstract: Objective To study the intramuscular repeated dose toxicity of recombinant hepatitis B vaccine in cynomolgus monkeys. Methods Thirty normal cynomolgus monkeys were divided into three groups：normal control group and recombinant hepatitis B vaccine groups (20, 40 μg, each animal). The cynomolgus monkeys were administered intramuscularly with corresponding dose of drug for four times and followed with four weeks withdrawal. The body weight, body temperature, ECG, ophthalmology, urine, hematology, blood biochemistry, immune indexes, viscera index and histopathology were examined to study the toxicity of recombinant hepatitis B vaccine in cynomolgus monkeys. Results The body weight gain of normal cynomolgus monkeys were slightly reduced after administration with recombinant hepatitis B vaccine (40 μg, each animal). Abnormal increase of the levels of NE%、EO% and slight muscle stimulation were also found after administration. High level of antibody was induced after administration with recombinant hepatitis B vaccine (20, 40 μg, each animal) for two times. Conclusion Recombinant hepatitis B vaccine intramuscularly taken showed significant immunogenicity(20, 40 μg, each animal) and there were slight toxicities on body weight, hematology and injection site after administration with recombinant hepatitis B vaccine (40 μg, each animal).

Key words: recombinant hepatitis B vaccine, toxicity, immunogenicity, cynomolgus monkey