Neonatal Hepatitis B Vaccine, Low / No Answer Immune Effect

BackgroundHepatitis B is one of the infectious diseases caused by the hepatitis B virus(HBV) globally.Hepatitis B is not only hurt people's health badly and but also cause serious economic burden,it has become a serious public health problem in China.Vaccination of Hepatitis B vaccine(HepB) is an effective way to prevent hepatitis B,which is the best way to interrupt mother-to-child transmission of HBV.The earlier the vaccination of HepB,the earlier the prevention of HBV infection.However,there are still some non-and-low responders to HepB after vaccination,who might be infected with HBV and have potential risk to be chronic carriers after the exposed to HBV.In China,the infants are priority population of vaccination.To find a effective way to decrease the rate of non-and-low responders among infants is the focus of researchers over the years, therefore it is necessary to explore the non-and-low responders after vaccination and determine the measures to improve the seroconversion of vaccination.In this study, Immunization effect is analyzed by revaccinating 3 doses HepB in non-and-low responders of infants,in order to improve the level of anti-HBs titer of the relevant reference for the strategy.Objectives1.To determine the immunogenicity of HepB primary immunization by different immune procedures.2.To determine the rate and related factors of non-and-low response among infants.3.To evaluate the immunization effect of different revaccination strategies to non-and-low response children,and to provide the guideline for the HepB immunization for non-and-low responder and the strategy for revaccination of non-and-low response children after basic HepB immunization.MethodsA survey was conducted and blood samples of the infants vaccinated 3 doses of HepB at 0,1,6 months in Guangzhou,Beijing and Ningbo was collected.Infants with hepatitis B surface antigen(HBsAg) negative,hepatitis B core antibody(anti-HBc) negative and anti-hepatitis B surface antibody(anti-HBs) titer＜100mIU/ml were given vaccine at 0,1,6 months and collected blood samples again after 1 dose and 3 dose of HepB.Using a questionnaire survey,we compile the gender,birthday,birth weight,HepB vaccination date,HepB vaccine types,HepB vaccine dose of infants and HBV infection status, pregnancy weeks of mothers.Blood samples were tested to HBsAg,anti-HBc and quantitative detection of anti-HBs titer.Data was inputted twicly by softeware of Epidata3.1 at site and national level,data was analysized by SPSS15.0.Results1.Of the three types of HepB immunization procedure,the GMT of 10μg-10μg-10μg, 10μg-5μg-5μg and 5μg-5μg-5μg was 275.34mIU/ml,236.76mIU/ml,226.15mIU/ml respectively;three types of positive rates of anti-HBs were 98.11%,98.12%,97.92%, and there was no significant difference(P＞0.05).2.Non-and-low responding rate of basic immunization after 3 doses of HepB was 18.54%,of which the low response rate was 16.53%and non-response rate was 2.02%;non response rates of 10μg-10μg-10μg,10μg-5μg-5μg and 5μg-5μg-5μg of three types of HepB vaccination were 1.89%,1.88%,2.08%respectively,there was no significant difference(P＞0.05),low responding rates were 8.49%,15.31%, 17.42%,in which 5μg-5μg-5μg group of low-response rate higher than the 10μg-10μg-10μg group with statistical significant difference(P＜0.05).3.The GMT of non-and-low responding children in group A(before revaccination), group B(after revaccinated 1 dose HepB) and group C(after revaccinated 3 dose HepB) were 21.33mIUml,88.82mIU/ml,167.10mIU/ml;the proportion of non-responders in three groups were 20.43%,9.09%,2.22%;proportion of low responders of group B and group C were 82.96%and 48.99%,and there was statistical significant difference(P＜0.05).4.The GMT after 3 doses revaccination with four kinds of HepB,included yeast 5μg, yeast 10μg,CHO 10μg,and Hansenula 10μg were 168.83mIU/ml,175.09mIU/ml, 150.88mIU/ml,177.73mIU/ml respectively;proportion of titers of 100mIU/ml and above for four kinds HepB were 82.61%,86.21%,80.49%and 83.33% respectively,and there was no significant difference(P＞0.05).Conclusions1.Three types of HepB immunization procedure of 10μg-10μg-10μg,10μg-5μg-5μg and 5μg-5μg-5μg have higher anti-HBs titer and positive rate of anti-HBs.And lower rate of responding can be produced in high-dose HepB.2.There was no statistical significant difference by gender,birth date,birth weight of infants and HBV infection status,pregnancy-cycle of mothers in this study.3.The immunization effect of revaccination of 3 doses HepB is better than revaccination of 1 dose HepB to the non-and-low responding children vaccinated at 0,1,6 months. 4.The four kinds of HepB,including yeast 5μg,yeast 10μg,CHO 10μg,and Hansenula 10μg,had basically the same immunization effect after 3 doses revaccination at 0,1,6 months to non-and-low response children.