| ObjectiveHepatitis B is a potentially life-threatening liver infection caused by the hepatitis B virus.It is a major global health problem.Since 1992,China had recommended the routine infant hepatitis B immunization to prevent perinatal transmission of hepatitis B virus(HBV).The prevelance of Hepatitis B surface antigen(HBsAg)among children<15 years old has discreased,but in adults it remains high.The adults become the main population for new hepatitis B virus infection.Now the percentage of adults who received hepatitis B vaccination is low.Conventional hepatitis B virus(HBV)vaccination fails to achieve efficient protection for the healthy adults.Some factors were reported to be associated with non-response to HepB primary vaccination,such as old age,male,obesity and comorbidities,etc.However,there are only a few studies examined the association between those factors and the response to HepB revaccination among non-responders.This study aimed to evaluate efficacy of hepatitis B vaccination among adults in Deqing County,and the influencing factors after premilary hepatitis B vaccination.Meanwhile,the effect and safety of one dose 60?g hepatitis B revaccination among non-response adults was also evaluated.MethodsThree towns were chosen,including west Mo gan shan town,central Qian yuan town and eastern Xin An town,and then two villages were selected in each town.The adults aged 16?49 years old who had not been vaccinated hepatitis B were enrolled.The survey was completed by the well-training doctors after obtaining written informed consent from the subjects.The questionnaire included gender,age,and Hepatitis B exposure history.5mL venous blood was collected;the serum was separated and stored under low temperature.Hepatitis B virus surface Antigen(HBsAg),Hepatitis B virus surface antibody(anti-HBs),and hepatitis B virus core antibody(anti-HBc)were tested,respectively.Three groups of subjects whose HbsAg and Anti-HBs were negative received intramuscular 10 ?g hepatitis B vaccine(yeast)at 0,1 and 3 months program(group A),0,1 and 6 months program(group B),or 0,1 and 12 months program(group C),respectively.5mL Blood samples were collected after first does and after the third dose,respectively.Individual who had anti-HBs titer less than lOmIU/Ml after primary vaccination cycle were defined as "non-responder".Non-responder received revaccination one dose of 60 ?g hepatitis B vaccine by intramuscular injection after the primary completion of a year.The revaccinations were measured height and weight at the scene.One month later,anti-HBs detection was conducted.Hepatitis B vaccine was provided by the Zhejiang Provincial Center for Disease Control and Prevention,the frozen separated serum samples were sent to ADICON Clinical Laboratories Inc.in Hangzhou for HBsAg,anti-HBs and anti-HBc quantification by chemiluminescence immunoassay(CLIA).An Architect-i2000(Abbott,US)analyzer was used to perform the CLIA.HBsAg ?0.05 mIU/mL was considered to indicate the presence of HbsAg.An anti-HBc antibody level ? 1.00 mIU/ml was considered as positive result.Anti-HBs level>10 mIU/mL was considered as seroprotection;a data base was established by EpiData,and double data entry was performed.Statistical analysis was performed using SPSS 19.0.Chi square was done for comparing between two qualitative variables.Fisher's exact test was used when the expected frequency is less.than 5.Odds ratio(OR)was estimated as a comparison of risk between the two studied groups.Mann-Whitney Utest was used for comparison between two means.Pearson correlation analysis was used for the GMT trend test.Multivariate logistic regression model was conducted to assess the risk factors of non-response.Results1.Primary hepatitis B vaccination689 subjects were received primary vaccination sucessfully.The seroprotection rate was 82.29%;No response rate was 17.71%.And the geometric mean titer(GMT)was 75.19 mIU/mL.The seroprotection rate of male and female were 82.33%and 82.27%,respectively.Gender difference in seroprotection rate was not significant(?2?0.001,P = 0.982).The GMT of male and female were 82.44 mIU/mL and 70.52 mlU/mL respectively,and the difference was not significant(Z=-0.02,P=0.988).The average positive rates were respectively 83.02%,85.42%,81.36%,79.69%,81.43%among the adults aged 16?,25?,30?,35?and 40?49 years,and the difference was not significant(?2=1.76,P = 0.780).The GMT was 107.43 mIU/mL,122.60 mIU/mL,61.48 mIU/mL,53.94 mIU/mL and 48.67 mIU/mL in each age group respectively.The GMT showed a down-ward trend with age(r =-0.13,P<0.001).The multivariate logistic regression analysis showed that odds ratio(OR)of hepatitis B vaccine non-responsiveness in group C was 2.09 times higher than that in group B(95%CI:1.26?3.46,P=0.004),OR of positive single hepatitis B core antibody(anti-HBc)in primary immune non-responder was 1.73 times higher than that in the anti-HBc negative group(95%CI:1.07?2.80,P = 0.026),OR of non-response in the subjects with surgical history was 1.56 times higher than that in those without surgical history(95%CI:0,96?2.53,P = 0.070).2.Hepatitis B revaccinationAmong 122 non-responders,89 non-responders were enrolled for one dose 60?g hepatitis B revaccination.The revaccination seroprotection rate was 95.51%.The GMT was 585.39 mIU/ml.After the revaccination,74.16%of the subjects had good response(anti-HBs titer>100mIU/ml).BMV ? kg/m2 was a risk factor for adult non-response to HepB revaccination(P=0.029).The multivariate logistic regression analysis showed that with the increase of BMI,there was a trend of increasing non-response rate(OR=1.20,P=0.133).Conclusions1.Immunization of hepatitis B primary vaccine at three doses 10 ?g had good immunogenicity.However,the GMT showed a down-ward trend with age.Immune response in the anti-HBc positive adults after primary immunization was weaker than that of anti-HBc negative group.The level of immune response to hepatitis B vaccine was lower than anti-HBc negative group,and revaccination could increase response rate.The seroprotection rates had better in 0?1?3 months or 0?1?6 months than in 0?1?12 months,but the long-term effects should be investigated in future.2.One dose 60?g hepatitis B revaccination had good effects in adults who had no response to primary vaccination,and weight control might improve the effects of hepatitis B revaccination. |
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