Hepatitis B vaccine alone may be enough for preventing hepatitis B virus transmission in neonates of HBsAg (+)/HBeAg (−) mothers

Background and aim

To prospectively evaluate the efficacy of vaccine alone compared with vaccine plus HBIG for preventing HBV transmission in neonates of HBsAg (+)/HBeAg (−) mothers.

Methods

Combined immunization is currently recommended for neonates of HBsAg (+) mothers in China. As a result, a randomized design is infeasible due to ethical reasons. In practice, Guangxi Zhuang Autonomous Region and Jiangsu Province implement vaccine alone and vaccine plus HBIG strategies for neonates born to HBsAg (+)/HBeAg (−) mothers, respectively. We alternatively enrolled neonates of HBsAg (+)/HBeAg (−) mothers from these two regions. Three doses of a recombinant yeast-derived hepatitis B vaccine were given at 0, 1 and 6 months with or without HBIG at birth.

Results

At 7 months, sera were collected from 132 neonates in Guangxi Zhuang Autonomous Region and 752 neonates in Jiangsu Province. Baseline characteristics of both mothers and neonates were comparable in the two regions. No differences were revealed regarding the occurrence of perinatal HBV transmission with or without HBIG at birth [0.1% (1/752) vs. 0.0% (0/132), p = 1.000]. The anti-HBs response rates were 97.7% (129/132) and 98.5% (740/751) for the neonates with vaccine alone and with HBIG (p = 0.758), respectively. Vaccine alone induced a significantly higher anti-HBs GMC as compared to vaccine plus HBIG at 7 months of age (1555.3 mIU/mL vs. 654.9 mIU/mL, p < 0.0001). At 12 months of age, protective levels of anti-HBs remained in 97.4% (596/612) and 98.3% (118/120) of the neonates receiving and not receiving HBIG, respectively (p = 0.771). The neonates receiving combined prophylaxis had a markedly lower anti-HBs GMC (210.7 mIU/mL vs. 297.0 mIU/mL, p = 0.011). Horizontal HBV transmission occurred in none of the successfully immunized neonates for both compared groups at 12 months of age.

Conclusions

Vaccine alone may be enough for preventing HBV transmission in neonates of HBsAg (+)/HBeAg (−) mothers.