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Hepatitis B vaccine response among infants born to hepatitis B surface antigen-positive women
Stephen C Ko1, Sarah F Schillie1, Tanja Walker1
1Division of Viral Hepatitis, National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention, Centers for Disease Control and Prevention, Atlanta, GA 30333, United States.
Insights
Most infants born to hepatitis B surface antigen-positive mothers respond to the hepatitis B (HepB) vaccine series. Optimal post-vaccination serologic testing (PVST) timing, within 1-2 months of the final dose, is crucial for accurate HepB vaccine response assessment.
Area of Science:
- Immunology
- Pediatrics
- Public Health
Background:
- Hepatitis B virus (HBV) infection poses a significant risk to infants born to infected mothers.
- Hepatitis B (HepB) vaccination and hepatitis B immune globulin (HBIG) are recommended at birth for infants of HBsAg-positive women.
- Completion of the HepB vaccine series and post-vaccination serologic testing (PVST) are critical for ensuring immunity.
Purpose of the Study:
- To evaluate factors influencing hepatitis B (HepB) vaccine response in infants born to hepatitis B surface antigen (HBsAg)-positive women.
- To identify predictors of non-response to the HepB vaccine series in a large cohort.
- To optimize the timing of post-vaccination serologic testing (PVST) for accurate assessment of vaccine-induced immunity.
Main Methods:
- Analysis of data from the Enhanced Perinatal Hepatitis B Prevention Program (EPHBPP) (2008-2013).
- Inclusion of HBsAg-negative infants born to HBsAg-positive mothers who received at least three HepB vaccine doses.
- Definition of vaccine non-responders as infants with antibody to hepatitis B surface antigen (anti-HBs) <10mIU/mL at PVST; multivariable analyses used to identify predictors of non-response.
Main Results:
- Of 8654 infants receiving ≥3 HepB vaccine doses, 94.7% responded to the primary series and 94.8% to a second series.
- Factors associated with non-response (anti-HBs <10mIU/mL) included preterm birth (<37 weeks), delayed birth dose (>12 hours), early final dose (<6 months), 3 vs. 4 doses, and prolonged PVST interval (>6 months).
- A PVST interval >6 months from the final dose significantly increased the odds of non-response (OR=2.7), with response rates decreasing from 98% at 1-2 months to 78.4% at 15-16 months post-vaccination.
Conclusions:
- The primary HepB vaccine series elicits a protective immune response in the vast majority (95%) of infants born to HBsAg-positive mothers.
- The interval between the final HepB vaccine dose and PVST is a critical factor influencing serologic response assessment.
- Optimal PVST timing within 1-2 months of the final HepB vaccine dose is recommended to accurately determine vaccine-induced immunity and avoid unnecessary revaccination.
Purpose:
Annually, an estimated 25,000 infants are born to hepatitis B surface antigen (HBsAg)-positive women in the United States. Hepatitis B (HepB) vaccine and hepatitis B immune globulin (HBIG) are recommended at birth, followed by completion of vaccine series and post-vaccination serologic testing (PVST). In a large cohort of infants born to HBsAg-positive women, factors influencing vaccine response were evaluated.
Methods:
Data were from HBsAg-negative infants born to HBsAg-positive women in the Enhanced Perinatal Hepatitis B Prevention Program (EPHBPP) from 2008 to 2013. Vaccine non-responders were defined as infants with antibody to hepatitis B surface antigen (anti-HBs) <10mIU/mL at PVST after receiving ≥3 vaccine doses. Multivariable analyses modeled statistically significant predictor variables associated with non-response.
Results:
A total of 17,951 maternal-infant pairs were enrolled; 8654 HBsAg-negative infants born to HBsAg-positive mothers received ≥3 doses of vaccine with anti-HBs results. 8199 (94.7%) infants responded to a primary HepB series; 199 (94.8%) to a second series. Factors associated with anti-HBs <10mIU/mL included gestational age <37 weeks, vaccine birth dose >12h after birth, timing of final vaccine dose <6 months after birth, receipt of 3 vs. 4 vaccine doses, and PVST interval >6 months from final vaccine dose in bivariate analysis. PVST interval >6 months from final vaccine dose (OR=2.7, CI=2.0, 3.6) was significantly associated with anti-HBs <10mIU/mL; the proportion increased from 2% at 1-2 months to 21.6% at 15-16 months after the final dose. Receipt of a 4th dose improved the response rate (OR=0.5, CI=0.3, 0.8).
Conclusions:
Ninety-five percent of a large cohort of uninfected infants born to HBsAg-positive mothers in the United States responded to primary HepB vaccine series. The proportion of infants with anti-HBs <10mIU/mL increased with longer interval between the final vaccine dose and PVST. Optimal timing of PVST is within 1-2 months of final vaccine dose to avoid unnecessary revaccination.
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