An Evaluation On Safety And Immunogenicity Of Two Different Cell Matrix Rabies Vaccines

Objective:1 To assess the Adverse events after the immunization,so as to compare the safety of the two kinds of rabies vaccine.2 To evaluate the immunogenicity of the two kinds of rabies vaccine by analyzing the serum antibody levels before the immunization,14 days and 42 days after the immunization.3 To evaluate the allergenicity of the two kinds of rabies vaccine by analyzing the serum IgE levels before the immunization,14 days and 42 days after the immunization.Methods:1 Objects and design1.1 Research objectsSelect the healthy people aged 10 to 60 years old of Yuncheng wanrong county,Shanxi Province,who met the inclusion criteria,and sign the informed consent.1.2 VaccinesFreeze-dried rabies vaccine for human use(MRC-5 cell)and Freeze-dried rabies vaccine for human use(vero cell)1.3 Grouping designSafety observation subjects is 1200 people;360 of the 1200 subjects need observe the immunogenicity by detecting the serum antibody levels;60 of the 360 subjects need observe the allergenicity by detecting the serum IgE levels.1.4 VaccinationEach subject have a dose of vaccine intramuscular inoculated on the upper arm lateral deltoid respectively on the day of 0,3,7,14,28.1.5 Safety observationWe use active report combined with regular follow-up way to observe the adverse reactions after vaccination since the first needle after vaccination to 4 weeks after immunization,and fill in the subject diary and source document.1.6 Immunogenicity and allergen observationThe subjects of immunogenicity observation group should detect the serum antibody levels at the first day,14th day and 42th day.In addition,60 subjects of the group should detect the serum IgE levels.1.7 Statistical analysisWe use epidata3.1 software to input electronic database.Checking the consistency of the data after double entry,to insure the data is correct.All the data were analyzed by SPSS 19.0 software.Results:1 Safety analysis results1.1 Analysis of the adverse reaction of active solicitationThe overall adverse reaction rate of the experimental group is 34.06%,and the control group is 42.67%.The overall local adverse reaction rate of the experimental group is 21.70%,and the control group is 25.33%.The overall systemic adverse reaction rate of the experimental group is 17.53%,and the control group is 23.50%.All the incidence of adverse reaction in the experimental group are significantly lower than the control group(P<0.05).The main local adverse reaction is pain,and the main systemic adverse reaction is fever.1.2 Analysis of the adverse reaction of passive assemblyThe overall adverse reaction rate of the experimental group is 11.02%,and the control group is 12.67%.The main adverse reaction in the clinical trail is grade 1 and grade 2,no grade 4 adverse reaction appeared.Comparing the adverse reaction incidence of the two groups,there were no significant differences(P>0.05).2 Immunogenicity analysis resultsThe overall antibody positive rate of the experimental group and the control group was 100%on the 14th day and 42th day after the immunization.The total GMC were 48.17 IU/ml and 50.18 IU/ml at the 14th day after the immunization,and there is no statistical difference between groups(P>0.05).The total GMC were 12.85 IU/m and 13.98 IU/ml at the 42th day after the immunization,and there is no statistical difference between groups(P>0.05).3 Allergenicity analysis results3.1 Comparing the serum IgE levels of the two groups before the immunization,14th day and 42th day after the immunization,there is no significant difference(P>0.05).3.2 Comparing the serum IgE antibody GMC of two groups at three different time points,there is no significant difference(P>0.05).The results show that the vaccine is safe and don't cause allergic reaction.Conclusion:The immunogenicity and allergenicity of Two different cell matrix rabies vaccinesfor Human Use are similar.The study also find that the adverse reaction of MRC-5 cells rabies vaccine is slightly lower than the other.