Hepatitis B Vaccine for Infants of HBsAg-Positive Mothers

Clinical Question

Do hepatitis B vaccine and immune globulin prevent hepatitis B infection in newborns of mothers who are positive for hepatitis B surface antigen (HBsAg)?

Evidence-Based Answer

Hepatitis B vaccine, hepatis B immune globulin, and the combination of both reduce the risk of transmission of hepatitis B virus from mother to newborn, especially in newborns of mothers positive for hepatitis B e antigen (HBeAg). The combination of vaccine and immune globulin is more effective than vaccine alone.

Practice Pointers

Without intervention, 70 to 90 percent of infants born to women who are positive for both HBsAg and HBeAg will have chronic hepatitis B infection by six months of age.¹ This Cochrane review of 29 clinical trials demonstrates that vaccine and immune globulin each are effective in preventing infection and that they are more effective in combination.

The reviewers found that compared with no intervention, hepatitis B immune globulin alone and the combination of immune globulin and vaccine reduced transmission of hepatitis B virus by 50 percent. The combination of vaccine and hepatitis B immune globulin also reduced transmission compared with vaccine alone (relative risk = 0.54; 95% confidence interval [CI], 0.41 to 0.73; 10 trials). Recombinant and plasma-derived vaccines were comparable in effectiveness, as were high-dose and low-dose vaccines.

Most of the trials included only mothers who tested positive for HBsAg and HBeAg. The number needed to treat to prevent transmission of hepatitis B from mothers who are positive for HBsAg but negative for HBeAg is likely to be much lower, but data for this population are limited.

The Advisory Committee on Immunization Practices recommends that all pregnant women be screened for HBsAg during routine prenatal care and that they be reevaluated and the results recorded when they report to the hospital in labor. Patients with positive results should be reported to local or state prenatal hepatitis B prevention programs and case-management tracking programs. Women who present in labor who are at high risk of infection or do not have HBsAg results should be tested as soon as possible. Newborns of mothers who are positive for HBsAg should receive single-antigen hepatitis B vaccine and hepatitis B immune globulin within 12 hours of birth. Thimerosal has been removed from vaccines, so neonatal vaccination can be performed.

Infants of mothers whose HBsAg status is unknown should receive single-antigen hepatitis B vaccine within 12 hours of birth. If the results of subsequent HBsAg testing of the mother are positive, the infant should receive hepatitis B immune globulin within seven days of birth. A complete hepatitis B vaccine series should be completed on all infants regardless of newborn vaccinations. At the end of the vaccination series at nine to 18 months, the infant should be tested for HBsAg and hepatitis B surface antibody.²