The Long-term Efficacy Of 17～20 Years After Being Immunized With Chinese Hamster Ovary Cell Derived Hepatitis B Vaccine And Antibody Response After Revaccination

Objectives 1 To observe the efficacy of Chinese Hamster Ovary(CHO)hepatitis B vaccine after completely primary vaccination for 17～20 years,and analyze the influencing factors of HBV infection.2 To observe immunogenicity of a booster vaccination and to analyze the influencing factors of unresponsive.3 Based on the above analysis and research,whether the adult completely primary vaccination needs to be strengthened.Methods A total of 1347 subjects born in lishuangdian,nangang,yongan,wuxing,quancheng,nanniu and zhufuton township between 1997～1999 and completed primary vaccination without booster immunization were enrolled.Questionnaire survey,blood sample collection and treatment and laboratory detection of Hepatitis B virus surface Antigen(HBsAg)and Antibody to Hepatitis B core Antigen(Anti-HBc)and Antibody to Hepatitis B surface Antigen(Anti-HBs)were conducted.Subjects who were negative in all three laboratory tests were randomly divided into two groups: the commercially available Chinese Hamster Ovary(CHO)vaccine(20μg)and the Brewer’s yeast vaccine(20μg).The Anti-HBs was retested one month later to observe the immunogenicity.SPSS was used for statistical analysis.Results 1 Basic immune effect study: The HBsAg positive rate was 0.45%,and the HBsAg positive rate for 17～20 years of immunization was 0.35%,0,0.84% and 0.94%,respectively.The Anti-HBc positive rate was 1.34%,and the Anti-HBc positive rate for17～20 years was 1.05%,0.63%,2.32% and 0.94%,respectively.The Anti-HBs positive rate was 74.61%,and the Anti-HBs positive rate for 17～20 years was 75.87%,75.63%,74.11% and 68.87%,respectively.There was no difference in Anti-HBs titer distribution among different immunization duration and gender(P>0.05).Anti-HBs GMC for 17～20 years was 151.36,177.01,162.56 and 164.44 m IU/m L,respectively.5 hepatitis B serological markers combination mode were detected in this study.Anti-HBs single positive detection rate(73.79%)was the highest,followed by three all-negative models(24.87%).Logistic regression revealed that long-term living HBsAg positive members is a risk factor for HBV infection(P=0.002,OR=7.494).2 Re-vaccinated immune effect study:The follow-up rate was 73.13%(245/335).Anti-HBs positive rate of population was 93.47%(229/245).Female positive rate(96.30%)was higher than male(90.00%)(P=0.047).The positive rates of the groups in 1997～1999 were 90.91%,96.15% and 93.67%,respectively,and the differences were not significant(P>0.05).The HepB(CHO)positive rate(97.62%)was higher than the HepB(yeast)(89.08%)(P=0.007).There was no difference in Anti-HBs titer distribution among gender and age groups(P>0.05).AntiHBs titer distribution was different among vaccine types,and the CHO group was higher(P=0.001).Anti-HBs positive GMC was 367.28 m IU/m L(95%CI:313.33,429.54).Among them,male Anti-HBs GMC was 345.14 m IU/m L and female was 384.59 m IU/m L,and the difference was not significant(P>0.05).Anti-HBs GMC in the groups of 1997～1999 was 376.70,340.41 and 385.48 m IU/m L,respectively,and the difference was not significant(P>0.05).Anti-HBs GMC in HepB(CHO)group was 420.73 m IU/m L,in HepB(yeast)group was 313.33 m IU/m L,with no significant difference(P>0.05).Univariate analysis showed that there were significant differences in Anti-HBs unresponsiveness rate among gender,vaccine type and Body Mass Index(BMI)(P<0.05).Logistic regression revealed that the higher the pre-booster anti-HBs level was,the lower the Anti-HBs unresponsiveness rate was(P=0.000,OR=0.044).The Anti-HBs unresponsive rate of the HepB(CHO)was lower than HepB(yeast)(P=0.015,OR=6.416).BMI is a risk factor for unresponsive Anti-HBs.With the increase of BMI,the unresponsive rate of Anti-HBs tends to increase(P=0.023,OR=2.704).Conclusions 1 The protective effect of HepB(CHO)vaccine was good after 17 to 20 years of primary immunization.2 Basic HBsAg,Anti-HBc and Anti-HBs negative individuals produced effective immune responses with one dose recombinant HBV vaccine,and a single booster dose of 20μg HepB(CHO)provided better immune response.The higher the pre-booster anti-HBs level was,the lower the Anti-HBs unresponsiveness rate was.The Anti-HBs unresponsive rate of the HepB(CHO)was lower than HepB(yeast).With the increase of BMI,the unresponsive rate of Anti-HBs tends to increase.3 Based on the results of this study,adults do not need to be immunized after completely primary vaccination.Figure 2;Table 20;Reference 144...