Preclinical safety and immunogenicity evaluation of pre-sealed syringe inactivated tick-borne encephalitis vaccine
Objective To evaluate the preclinical safety and immunogenicity of 0.5 mL/dose of inactivated tick-borne encephalitis(TBE)vaccine with pre-sealed syringe.Methods The safety of the new packaged TBE inactivated vaccine was evaluated by using rabbit muscle irritation test and guinea pig systemic active anaphylaxis test,and compared with that of the original package(1.0 mL/bottle,cillin bottle).Thirty Kunming mice with 10-12 g body mass were immunized i.p.with TBE inactivated vaccines of new package and original package twice at an interval of 7 d,respectively.At 14 d after the initial immunization,the experimental group was challenged with virus(TBEV of"Senzhang"strain)of 10-2-10-6 dilu-tion,while the control group with the virus of 10-6-10-10 dilution by intraperitoneal administration.The results were obser-ved continuously for 21 d,and the immunogenicity of the TBE inactivated vaccines was evaluated by calculating the titer using Reed-Muech method.Results No death or dying condition was observed in all the groups of animals in the rabbit irritation test,and no abnormal reaction was observed in all groups in the guinea pig systemic active allergic reaction test.The immuno-genicity(immune protection index)of three batches of TBE inactivated vaccines with original package was 1.0 × 108,1.3 × 108,1.0 × 108,and that of three batches of TBE inactivated vaccines with new specification were 1.1 × 108,1.0 × 108 and 1.3 × 108,respectively,which met the requirements of greater than 1.0 × 105 in Chinese Pharmacopoeia(Volume Ⅲ,2020 edition),with no significant difference in immunogenicity between the vaccines of new and original specifications(F=0.063,P＞0.05).Conclusion The 0.5 mL/dose of pre-sealed syringe TBE inactivated vaccine has good preclinical safety and immunogenicity.
Tick-borne encephalitis virus(TBEV)Inactivated vaccine for tick-borne encephalitisPre-sealed syringeSafetyImmunogenicity
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