| Objectives1. To determine the safety and immunogenicity of different doses of HepB in infants.2. To determine the relationship between Human Leukocyte Antigen (HLA) and non-and-low resonponding infants after the inoculation of different doses of HepB.3. To evaluate the safety and immunogenicity of high-dose vaccination (10μg) of HepB in infants, and to provide the scientific basis for the adjustment of HepB vaccination program in infants.MethodsA survey of infants born in local maternity was conducted in Yuyao and Ninghai.Following the principle of that, the infants born in Ninghai local maternity and mothers with hepatitis B surface antigen (HBsAg) negative was vaccinated 5μg,and all infants born in Yuyao local maternity and the infants in Ninghai local maternity and mothers with HBsAg positive was vaccinated 10μg,the infants vaccinated 3 doses of HepB at 0,1,6months collected the blood samples first in 1-2months after the vaccination program;then collected the blood samples second in 6 months after the vaccination program,based on the first blood samples.Then to study the relationship between the infants with hepatitis B surface Antibody(anti-HBs) <100mIU/ml and HLA DRB1*07,DRB1*04,DRB1*1501and DQB1*0401 in the results of the first blood.Using questionnaire surveys,we would know the gender,birth weight,HepB vaccine dose of infants,HBV infection of mothers and the safety status.Blood samples were tested to quantitative detection of HBsAg,anti-HBs and anti-HBc. Data was inputted twicly by software of Epi Data3.1, and data was analysized by SPSS16.0.Results1. In the study of 3604 times HepB vaccination, 3 cases of adverse reactions were found, and that were common reactions after HepB vaccination, the total adverse reaction rate was 83.24/1 million.2. Of the two different doses of 5μg and 10μg HepB immunization procedure, after 1-2 months,the Geometric Mean Titer (GMT) was 810.44 mIU/ml, 3114.23 mIU/ml respectively;two different doses of positive rate of anti-HBs were 93.63%,98.72%,and there was significant difference (P<0.05). After 6 months, the GMT of 5μg and 10μg was 320.65mIU/ml, 964.57mIU/ml respectively;two different doses of positive rate of anti-HBs were 81.91%,96.57% respectively,and there was significant difference(P<0.05).3.1-2 months after the inoculation of the two different doses of 5μg and 10μg HepB,non-and-low responding rates were 1.01%,0.00% respectively; 6 months after the inoculation of 5μg and 10μg hepB, low-and-non responding rates were 18.19%, 3.42 %, respectively, and there was significant difference(P<0.05).4. HBsAg positive mothers in different infection status, there were no significant differences between both of the gender and birth weight.There was significant difference(P<0.05) between the non-and-low responding infants and HLA DRB1 * 04,there were no significant difference(P>0.05) between the non-and-low responding infants and HLA DRB1 * 07, DRB1 * 1501 and DQB1 * 0401.Conclusions1. The two different doses of 5μg and 10μg HepB vaccination have higher anti-HBs titer and positive rate of anti-HBs.And they were safe.2. The infants vaccinated 3 doses of HepB at 0,1,6 months,the low-and-non responding rates inoculated 10μg HepB was lower than inoculated 5μg HepB,and low-and-non responding rates can decline after the higher dose immunization.3. The comparison of 1-2 months and 6 months after immunization, both of the GMT of anti-HBs after 10μg vaccination and the GMT of anti-HBs after 5μg vaccination declined,the GMT of anti-HBs of high doses HepB vaccination was still better than low doses HepB vaccination.And the GMT of anti-HBs of high doses can last longer.4. Low-and-non responding rate of 6 months after immunization was lower than 1-2 months after immunization.So anti-HBs titer and positive rate would diminish, as time went on. |
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