Influencing factors for low response to hepatitis B vaccination in neonates
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摘要: 目的探索HBs Ag阳性母亲分娩的新生儿在接受乙型肝炎疫苗(Hep B)后发生免疫低应答的相关影响因素。方法招募了2012年7月-2015年7月参加HBV母婴传播阻断项目的 1152例HBs Ag阳性母亲分娩的新生儿,剔除了96例后,共1056例研究对象纳入分析,其中包含HBs Ag阳性/HBe Ag阴性母亲分娩的新生儿714例,HBs Ag阳性/HBe Ag阳性母亲分娩的新生儿342例。HBs Ag阳性/HBe Ag阴性和HBs Ag阳性/HBe Ag阳性母亲分娩的新生儿采用不同剂量的免疫接种方案,分别在其出生后2 h内注射10μg或20μg重组酵母Hep B,并联合100 IU乙型肝炎免疫球蛋白(HBIG),于1月龄及6月龄时再分别注射一剂10μg或20μg的Hep B。采集末次免疫后1个月的静脉血检测HBs Ag及抗-HBs水平。抗-HBs水平<100 m IU/ml为低应答者,抗-HBs水平≥100 m IU/ml为高应答者。对计量资料应用两独立样本t检验进行组间比较,计数资料应用χ2检验或Fisher精确检验进行组间比较。采用非条件logistic回归来分析新生儿Hep...Abstract: Objective To investigate the influencing factors for low response to hepatitis B (Hep B) vaccination in neonates born to HBs Ag-positive mothers. Methods A total of 1152 neonates born to HBs Ag-positive mothers who participated in the project of prevention of mother-to-child transmission of HBV from July 2012 to July 2015 were enrolled. After 96 neonates were excluded, 1056 neonates were included in the final analysis, including 714 neonates born to HBs Ag-positive/HBe Ag-negative mothers and 342 neonates born to HBs Ag-positive/HBe Ag-positive mothers. These two groups of neonates were given immunization at different doses, i. e., 10 μg or 20 μg Hep B derived in Saccharomyces cerevisiae and 100 IU hepatitis B immunoglobulin within 2 hours after birth, followed by the injection of 10 μg or20 μg Hep B at the ages of 1 and 6 months. Venous blood samples were collected at one month after the last immunization to measure the levels of HBs Ag and anti-HBs. The neonates with anti-HBs < 100 m IU/ml were classified as low responders, and those with anti-HBs ≥100 m IU/ml were classified as high responders. The two-independent-samples t test was used for comparison of continuous data between groups, and the chi-square test or the Fisher's exact test was used for comparison of categorical data between groups. An unconditional logistic regression analysis was used to identify the influencing factors for low response to Hep B in neonates. An analysis of covariance was used for comparison of the level of anti-HBs between groups. Results Compared with the 20 μg group, the 10 μg group had a significantly higher rate of low response (5. 7% vs 2. 0%, χ2= 7. 278, P = 0. 007) , significantly lower maternal HBV DNA load [ (2. 90 ± 1. 50) log10 IU/ml vs (7. 73 ± 1. 07) log10 IU/ml, t =-50. 297, P < 0. 001) ]and proportion of the mothers who received antiviral therapy during pregnancy (0. 7% vs 7. 0%, χ2= 34. 552, P < 0. 001) , and a significantly higher rate of preterm birth (3. 2% vs 1. 2%, χ2= 3. 907, P =0. 048) . The 10 μg group had a significantly lower proportion of neonates with artificial feeding than the 20 μg group (37. 8% vs 66. 4%, χ2= 75. 703, P < 0. 001) . In the 10 μg group, the unconditional logistic regression analysis showed that preterm birth (odds ratio [OR]=3. 31, 95% confidence interval [CI]: 1. 05-10. 40, P < 0. 05) and artificial feeding (OR = 2. 67, 95% CI: 1. 38-5. 07, P < 0. 05) were independent risk factors for low response to Hep B vaccination. The analysis of covariance showed that compared with the full-term infants, the preterm infants had a significantly lower level of anti-HBs (P = 0. 004) ; compared with those given breastfeeding or mixed feeding, the neonates given artificial feeding had a significantly lower level of anti-HBs (P = 0. 001) . In the 20 μg group, no maternal factors or infantile factors were found to be associated with the response to Hep B vaccination (all P > 0. 05) . Conclusion Preterm birth and artificial feeding are risk factors for low response to Hep B vaccination in neonates. Identification of neonates at risk of low response to Hep B vaccination will provide a basis for developing individualized Hep B vaccination schemes.
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Key words:
- hepatitis B vaccines /
- infant, newborn
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