| Objective:In recent years,public health emergencies and outbreaks caused by chicken pox still occur in China,the high proportion of breakthrough cases after an injection of varicella vaccine,the phenomenon hints that traditional chicken pox vaccine one dose immunization program may not be effective in the prevention of chickenpox and breakthrough cases occurred.Safety and immunogenicity of this study was to evaluate the varicella vaccine immunization program for the two doses,for promoting two doses varicella vaccine immunization program and regularizing two doses interval immunization program to provide data support.Methods:Using the method of field trial,in Wanrong County,Shanxi province were selected to meet the conditions of 1-12 years old healthy children 1800,divided into 1-3 years old,4-6 years old and 7-12 years old three age groups.The proportion of each age group according to 2:2:1:1 were randomly divided into experimental group 1,experimental group 2,control group 1and control group 2.The subjects in experimental group 1 were vaccinated two doses of varicella vaccine interval 3 months,the subjects in experimental group 2 were vaccinated two doses of varicella vaccine interval 6 months,the subjects in control group were vaccinated one dose of hepatitis B vaccine.The subjects in experimental group 1 and experimental group 2 were drawn blood before vaccination and after every dose of vaccination 1.5 months,the subjects in control group 1 were drawn blood before vaccination and after vaccination 1.5 months and 4.5 months,the subjects in control group 2 were drawn blood before vaccination and after vaccination 1.5 months and 7.5 months.To evaluate immunogenicity by using membrane immunofluorescence to test the Antibody titers,observed and recorded the adverse reactions to evaluate safety.To use Epidata3.1 software to input and file data,using SPSS18.0 software to statistics and analysis data,measurement data two groups mean compared using t-test,multiple group mean compared using analysis of variance,rates were compared using the ?~2 test,multiple comparisons between groups were used LSD-t method.Results:In this study,1800 subjects were enrolled in this study,there were 904 males and896 females,the ratio was about 1:1.The average age of the study group was 5.81±0.09years old,the average age of the control group was 5.74±0.13 years old.There was no significant difference in the gender and age of the study group and the control group(P(29)0.05).There was no significant difference in GMT levels before vaccination between study group and control group(P(29)0.05).In total 1800 subjects,1744 of them completed the whole process of safety observation,the safety research completion rate was 96.89%,1622 subjects completed the whole process of immunogenicity and obtained effective serological data,the immunogenicity research completion rate was 90.11%.After the second dose of varicella vaccine vaccinated,the total adverse reaction rate occurred between 3%and 8%,which local adverse reactions in about 1%,systemic adverse reactions at around 2%-7%,the rate of adverse reactions after the second dose of varicella vaccine with different inoculation interval had no significant difference(P>0.05).After the second dose of varicella vaccine vaccinated,the local adverse reactions were mainly manifested as pain and redness at the inoculation site,systemic reactions mainly included fever and rash,severity was mainly mild to moderate,and no severe adverse reactions occur.The GMT level was 1:107.54-1:199.28 after one dose varicella vaccine vaccination,the GMT level was 1:435.03-1:733.47 after two doses varicella vaccine vaccination.The GMT levels after one dose varicella vaccine vaccination higher than that by the former,the difference has statistically significant(P<0.001);the GMT levels after two doses vaccination higher than one dose vaccination,the difference has statistically significant(P<0.001).The difference of GMT level after 3 months and 6 months inoculation with second dose of the vaccine has no statistically significant(P(29)0.05).Between different age groups,the GMT levels after one dose vaccination had significant difference(P<0.01),the GMT levels after two doses vaccination had significant difference(P<0.001),the 1-3 years old group were higher than 4-6 years old group and 7-12 years old group(P<0.05),the difference was no statistically significant between 4-6 years old group and7-12 years old group(P(29)0.05).After 3 months and 6 months inoculation with second dose of the vaccine,the GMT 4 times growth rate second dose of vaccination compared first dose of vaccination were no significant difference(P>0.05).After one dose vaccination,the antibody positive conversion rate was 85.21%-93.21%,after two doses vaccination,the antibody positive conversion was 97.81%-99.14%.The antibody positive conversion rate after two doses of vaccination was higher than one dose of vaccination,the difference has statistically significant(P<0.001).There was no significant difference in the antibody positive conversion rate between interval 3 months and 6 months vaccination the second dose of varicella vaccine(P(29)0.05).Conclusion:In 1-12 years old healthy children were vaccinated with two doses of varicella vaccine,which had good safety and serological protection effect.Compared vaccination one dose of varicella vaccine with vaccination two doses varicella vaccine,the GMT and antibody positive conversion rate was significantly increased.There was no significant difference in the antibody positive conversion rate and GMT level after interval 3 months and 6 months vaccination the second dose varicella vaccine. |
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