A Cochrane [Abstract] 1 review included 29 trials, 5 of which were high quality. Compared with placebo/no intervention, vaccine reduced hepatitis B occurrence (RR 0.28, 95% CI) 0.20 to 0.40, 4 trials). No significant differences of hepatitis B occurrence were found comparing recombinant vaccine (RV) versus plasma-derived vaccine (PDV) (RR 1.00, 95% CI 0.71 to 1.42, 4 trials) and high-dose versus low-dose vaccine (PDV: RR 0.97, 95% CI 0.55 to 1.68, 3 trials; RV: RR 0.78, 95% CI 0.31 to 1.94, 1 trial). Compared with placebo/no intervention, hepatitis B immunoglobulin or the combination of vaccine plus hepatitis B immunoglobulin reduced hepatitis B occurrence (hepatitis B immunoglobulin: RR 0.50, 95% CI 0.41 to 0.60, 1 trial; PDV plus hepatitis B immunoglobulin: RR 0.08, 95% CI 0.03 to 0.17, 3 trials). Compared with vaccine, vaccine plus hepatitis B immunoglobulin reduced hepatitis B occurrence (RR 0.54, 95% CI 0.41 to 0.73, 10 trials). Hepatitis B vaccine and hepatitis B immunoglobulin seem safe, but few trials reported on adverse events.
A prospective observational cohort study 3 included 863 HBsAg-positive mothers and their 871 infants. Initial injections of hepatitis B immunoglobulin (HBIG) and the hepatitis vaccine were given within 2 hours after birth. At 7 months of age, no immunoprophylaxis failure was observed in the 565 infants born to HBeAg-negative mothers. Among the 306 infants born to HBeAg-positive mothers, immunoprophylaxis failed in 16 infants (5.2%) of the infants and they were found to be HBsAg-positive. HBV DNA levels ≥10 IU/mL, delayed vaccination over 2 hours (OR 4.14, 95% CI 1.00 to 7.18), and inadequate initial injection dose (OR 7.69, 95% CI 1.71 to 34.59) were independently associated with immunoprophylaxis failure. Adequate titers of antibody to HBsAg (anti-HBs, ≥100 mIU/mL) were present in 96.5% of immunoprophylaxis-successful infants.
A systematic review 2 including 32 studies was abstracted in DARE. All mothers of the study participants were positive for hepatitis B e antigen. The protective efficacy reported in the individual studies ranged from 42% to 100% in the plasma-derived vaccines, and from 66% to 100% in the recombinant DNA vaccines. Lower doses of PDV tended to give lower protective efficacy rates if no hepatitis B immunoglobulin was provided. 7 studies showed protective efficacy of low doses of PDV was increased when hepatitis B immunoglobulin is administered. This increase was not seen at doses of 10 µg or more of PDV.
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