The immunogenicity in healthy infants and efficiency to prevent mother to child transmission of Hepatitis B virus of a 10 μg recombinant yeast-derived Hepatitis B vaccine (Hep-KSC)

Abstract

Background and AimsTo evaluate immunogenicity and efficacy of a 10μg recombinant Saccharomyces cerevisiae-derived hepatitis B vaccine (Kangtai Biological Products Co. Ltd, Shenzhen, China) (Hep-KSC) in newborns. MethodsOverall 1197 infants born to mothers negative for HBV markers (NM group) and 534 born to HBsAg-positive mothers (PM Group) were enrolled. Infants in NM group were given 10μg Hep-KSC, 10μg Engerix-B or 5μg Hep-KSC and those in PM group received 10μg Hep-KSC or 10μg Engerix-B at 0, 1 and 6 months, with an additional 200IU HBIG at birth for the latter. ResultsFor NM Group, 10μg Hep-KSC paralleled 10μg Engerix-B but outperformed 5μg Hep-KSC regarding seroprotective rate (95.06% vs 94.83% vs 89.67%, p=0.0077) and anti-HBs geometric mean concentration (GMC) (798.87mIU/ml vs 790.16mIU/ml vs 242.04mIU/ml, p<0.0001) at 7 months. The proportion of infants with anti-HBs greater than 1000mIU/ml was higher in 10μg Hep-KSC than 5μg Hep-KSC group (45.77% vs 11.93%, p<0.0001) at 7 and 12 months. For PM Group, the HBsAg positivity rate in 10μg Hep-KSC and 10μg Engerix-B group was 1.60% and 4.27% at 7 months, respectively. In 10μg Hep-KSC group, 93.61% and 91.29% achieved seroprotection at 7 and 12 months, respectively, and correspondingly 90.24% and 86.96% in 10μg Engerix-B group. The anti-HBs GMC was comparable between 10μg Hep-KSC and 10μg Engerix-B group at 7 and 12 months (575.31mIU/ml vs 559.64mIU/ml; 265.79mIU/ml vs 264.48mIU/ml). Conclusions10μg Hep-KSC might be appropriate for neonatal immunization with good immunogenicity and efficacy, especially for infants born to HBsAg-positive mothers.