[Efficacy of recombinant hepatitis B vaccine and low-dose hepatitis B immune globulin in preventing mother-infant transmission of hepatitis B virus infection].
OBJECTIVE
To determine the efficacy of recombinant hepatitis B (rHB) vaccine and low-dose hepatitis B immune globulin (HBIG) in the prevention of mother-infant transmission of hepatitis B virus (HBV) infection.


METHODS
rHB vaccine was administered to two groups of healthy neonates born to mothers with both hepatitis B surface antigen and e antigen positive in Guangxi, Hunan and Hebei province. Two hundred eighty-nine subjects were included in active immunization group, receiving triple doses of rHB vaccine given i.m. at 0, 1 and 6 month intervals; while 186 subjects receiving 50 IU HBIG at birth with triple doses of rHB vaccine in the low-dose HBIG group.


RESULTS
Efficacy of active immunization alone was 87.8% (95% CI: 83.6 - 91.9). Efficacy of rHB vaccine and HBIG was 91.2% (95% CI: 86.7 - 95.6). No significant differences in efficacy by type of rHB vaccine (P = 0.707 2), immunoprophylaxis programs (P = 0.295 5) and regions of living (P = 0.998 7) were noticed. Seroprotection rates (anti-HBs >or= 10 mIU/ml) were detected in 91.1% and 93.5% in rHB vaccine alone recipients and rHB vaccine plus HBIG recipients, with geometric mean titer (GMT) of 153 mIU/ml and 164 mIU/ml at 1 year of age, respectively. Anti-rHBs decreased significantly with years after vaccination (chi(2) = 60.47, P = 0.000 1). Seroprotection rates of anti-rHBs antibodies decreased to 65.0% and 66.6% at 4 years of age in rHB vaccine alone recipients and rHB vaccine plus HBIG recipients, with GMT of 55 mIU/ml and 56 mIU/ml, respectively.


CONCLUSIONS
These results suggested that the effectiveness of rHB vaccine plus low-dose HBIG was much better than only active plasma-derived vaccine; however, methods used for anti-rHBs assay need to be evaluated and verified.
Xia
Guo-liang
GL
Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing 100052, China.
Gong
Jian
J
Wang
Ji-jie
JJ
Meng
Zong-da
ZD
Jia
Zhi-yuan
ZY
Cao
Hui-lin
HL
Liu
Chong-bai
CB
D002681:China / Q000453:epidemiology; D005260:Female; D006509:Hepatitis B / Q000453:epidemiology / Q000517:prevention & control* / Q000635:transmission; D006510:Hepatitis B Antibodies / Q000008:administration & dosage*; D017325:Hepatitis B Vaccines / Q000276:immunology; D006801:Humans; D007115:Immunization Schedule; D007074:Immunoglobulin G / Q000008:administration & dosage; D007231:Infant, Newborn; D018445:Infectious Disease Transmission, Vertical / Q000517:prevention & control*; D008297:Male; D014611:Vaccination; D014614:Vaccines, Synthetic / Q000276:immunology
D006510:Hepatitis B Antibodies; D017325:Hepatitis B Vaccines; D007074:Immunoglobulin G; D014614:Vaccines, Synthetic