Abstract: Objective To compare the acute toxicity reaction of PIKA hepatitisB therapeutic vaccine(CHO cell) and its component on mice,which is PIKA adjuvant and recombinant hepatitisB vaccine(CHO cell). Methods ICR mice were randomized into solvent control group, high dose and low dose(PIKA adjuvant stoste and 2 times diluent) of PIKA adjuvant groups, recombinant hepatitis B vaccine(CHO cell) and high dose and low dose(vaccine stoste and2 times diluent ) of PIKA hepatitis B therapeutic vaccine ( CHO cell ) . Mice were administrated intramuscularly once with tested drugs(0.2 mL) and continuously observed for 14d for acute toxicity symptoms. Results All mice of every group survived and there were no toxicological changes in body weight, feed consumption, injection agents, appearance, behavioral activity, respiratory system, dejecta, organ macroscopic and pathological examination related to the tested drugs. Conclusion There is no obvious acute toxicity reaction on mice treated with PIKA hepatitis B therapeutic vaccine(CHO cell) and its component.

Key words: PIKA hepatitis B therapeutic vaccine(CHO cell), acute toxicity reaction, mice