Abstract

This study aimed to find out the immune response effects and side effects after recombinant yeast hepatitis B vaccine inoculation in neonates. All 203 neonates were divided into three groups: 25 subjects in group A whose mother was HBsAg(+) HBeAg(+), 43 subjects in group B whose mother was HBsAg(+) HBeAg(-) and 135 subjects in group C whose mother was HBsAg(-). The immune response effects at 12th month after first inoculation were compared and side effects were observed. Non-responders received re-immunization at 12th month after first inoculation and immune response effects were compared at 36th month after first inoculation. There was no significant difference of anti-HBsAg(+) neonates proportion between group “A plus B” and group C, neither between group B and C at 12th month after innoculation. But there were significant differences between group A and B or C. There were 3, 1 and 0 HBsAg(+) neonates in 3 groups at 12th month after the first inoculation. There were 5, 2 and 10 infants identified as non-responders and received re-immunization in 3 groups. Among of the “non-responders” significant differences were found in anti-HBsAg(+) proportion between group “A plus B” and group C at 36th month. Only 1 HBsAg(+) was found in group A at 36th month. All subjects of responders remained anti-HBsAg(+) at 36th month. No serious side effects were found. This China-made recombinant yeast hepatitis B vaccination is safe and effective to prevent HBV vertical transmission. HBsAg and HBeAg status of mother perhaps affect the immune response effects on neonates.

Key words: Recombinant yeast hepatitis B vaccine, neonates.