美国每年大约有25,000个婴儿出生自乙肝表面抗原(HBsAg)阳性的母亲。指南推荐婴儿在出生时接受乙肝疫苗和乙肝免疫球蛋白(HBIG)，随后再接受3或4次疫苗注射。疫苗接种后血清试验（PVST）反应阳性指最后一次接种后乙肝表面抗体(anti-HBs) ≥10 mIU/mL，一般在9-18个月龄时最典型。第64届美国肝病研究学会（AASLD）年会公布了一项乙肝表面抗原阳性母亲所生婴儿的大样本队列研究，旨在评估影响疫苗接种反应的因素。

研究方法

对2008年-2012年间加入提高围产期乙肝预防(EPHBP)计划的乙肝表面抗原阳性母亲所生乙肝表面抗原阴性婴儿的数据进行分析。乙肝表面抗体<10 mIU/mL的定为对疫苗无反应。应用双变量分析确定疫苗无反应的相关因素。应用多变量分析计算比值比(OR)和95%置信区间(CI)，预示在统计学上有显著性差异。

研究结果

共有16,704个婴儿出生自乙肝表面抗原阳性的母亲。孕妇的中位年龄为30.1岁，64.6%的孕妇是亚洲或太平洋岛屿上的人。8,654个婴儿接受至少3次疫苗接种然后应用疫苗接种后血清试验检测乙肝表面抗体，8,199 (94.7%)个婴儿第一次接种后就发生反应。与乙肝表面抗体<10mIU/mL相关的因素有孕周<37周、第一次疫苗接种时间超过出生后12小时、与最后一次疫苗接种时间相差6个月以上、接受3或4次疫苗接种、疫苗接种后血清试验时间超过最后一次疫苗接种6个月。排除相互作用和干扰后，疫苗接种后血清试验时间与最后一次疫苗接种时间相差6个月以上与乙肝表面抗体<10mIU/mL显著相关(OR=2.7, CI=2.0, 3.6)，而接受4次疫苗接种能稍稍提高阳性反应的发生率(OR=0.5, CI=0.3, 0.8)。1-2个月后疫苗接种后血清试验得到婴儿乙肝表面抗体 <10mIU/mL结果的比例为2%，而11-12个月后该比例上升到13.3%。

结论

95%的乙肝表面抗原阳性母亲所生的婴儿对乙肝疫苗接种发生反应。乙肝表面抗体 <10mIU/mL婴儿的比例随着疫苗接种后血清试验时间与最后一次接种乙肝疫苗的时间间隔的增加而增加。尽管疫苗接种后血清试验时乙肝表面抗体 <10mIU/mL，但是如果婴儿初始的乙肝表面抗体≥10 mIU/mL，那么这些婴儿也会得到保护。为了避免不必要的重复接种，疫苗接种后血清试验的时间应该在最后一次接种后的6个月内。

原文摘要

PURPOSE: Annually, an estimated 25,000 infants are born to hepatitis B surface antigen (HBsAg)-positive women in the United States. Hepatitis B (HepB) vaccine and hepatitis B immune globulin (HBIG) are recommended at birth, followed by completion of the 3 or 4 dose HepB vaccine series. Post-vaccination serologic testing (PVST) response is defined by antibody to hepatitis B surface antigen (anti-HBs) ≥10 mIU/mL after the final dose, typically performed at age 9-18 months. In a large cohort of infants born to HBsAg-positive women, factors influencing vaccine response were evaluated. 

METHODS: Data were analyzed from HBsAg-negative infants born to HBsAg-positive women enrolled in the Enhanced Perinatal Hepatitis B Prevention (EPHBP) Program from 2008-2012. Vaccine non-responders were defined as infants with anti-HBs <10 mIU/mL. Factors associated with non-response were identified in bivariate analyses. Odds ratios (OR) and 95% confidence intervals  (CI) were calculated from multivariable analyses after inclusion of statistically significant predictor variables 

RESULTS: 16,704 infants were born to HBsAg-positive mothers. Median maternal age was 30.1 years and 64.6% were Asian/Pacific Islander. 8,654 infants with at least 3 doses of vaccine received PVST for anti-HBs and 8,199 (94.7%) responded to the initial vaccination series. Factors associated with anti-HBs <10mIU/mL included gestational age <37 weeks, vaccine birth dose >12 hours after birth, timing of last vaccine dose <6 months after birth, receipt of 3 vs. 4 vaccine doses, and PVST interval >6 months from final vaccination dose. After assessing for interaction and confounding, PVST interval >6 months from last vaccination dose (OR=2.7, CI=2.0, 3.6) was significantly associated with anti-HBs <10mIU/mL, while receipt of a 4th dose slightly improved the response rate (OR=0.5, CI=0.3, 0.8). The proportion of infants with anti-HBs <10mIU/mL increased from  at 1-2 months PVST to 13.3% at 11-12 months PVST. 

CONCLUSIONS: Ninety-five percent of all infants born to HBsAg-positive mothers responded to a primary HepB vaccine series. The small proportion of infants with anti-HBs <10mIU/mL increased with longer interval between the final vaccine dose and PVST. Although their anti-HBs levels were <10mIU/mL at the time of PVST, some infants might have been protected if their initial anti-HBs was ≥10 mIU/mL. To avoid unnecessary revaccination, optimal timing of PVST is within 6 months of final vaccination.

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