[Comparing immunogenicity and efficacy of two hepatitis B vaccines in newborn infants of hepatitis B surface antigen (+)/hepatitis B e antigen (+) carrier mothers]

Objective: To evaluate the effect of yeast recombinant HBV vaccine on protecting the newborns from HBV carrier mothers and to compare with plasma-derived vaccine.
Methods: There were 117 neonates from HBsAg(+)/HBeAg(+) carrier mothers involved in the study. Study group [76 of them received RECOMBIVAX HB(5 mcg/0.5 ml)] and control group (41 neonates receive plasma derived vaccine) had blood samples collected and received vaccine at 0, 1, 6, 9 month after birth respectively. HBV-DNA, HBsAg/HBeAg, HBsAb were determined by PCR, ELISA, RIA independently.
Results: (1) Children chronic HBV infection rates at 6, 9 month of age in study group were 7.89%, 5.26% respectively, which were lower than that of control group(14.63%, 17.07%). (2) The vaccine efficacy (VE) in study group was 93.82%, vs, that of control group was 79.92%. (3) The HBsAb positive rate in study group at 9 month of age was 94.74% which was significantly higher than that of control group(80.49%) (P < 0.05). (4) The difference of side-effect rates between the two groups was not significant.
Conclusion: Immunogenicity and efficacy of yeast-recombinant hepatitis B vaccine is better than that of plasma derived vaccine in newborn infants of HBsAg(+)/HBeAg(+) carrier mothers.