title: Hepatitis B vaccine response among infants born to hepatitis B surface antigen-positive women.
abstract: OBJECTIVE
  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.
authors.affiliation: Division 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. Electronic address: shk3@cdc.gov.
authors.forename: Stephen C
authors.initials: SC
authors.lastname: Ko
authors.affiliation: Division 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.
authors.forename: Sarah F
authors.initials: SF
authors.lastname: Schillie
authors.affiliation: Division 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.
authors.forename: Tanja
authors.initials: T
authors.lastname: Walker
authors.affiliation: Division 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.
authors.forename: Steven L
authors.initials: SL
authors.lastname: Veselsky
authors.affiliation: Division 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.
authors.forename: Noele P
authors.initials: NP
authors.lastname: Nelson
authors.affiliation: New York City Department of Health and Mental Hygiene, New York, NY, United States.
authors.forename: Julie
authors.initials: J
authors.lastname: Lazaroff
authors.affiliation: Minnesota Department of Health, Saint Paul, MN, United States.
authors.forename: Susan
authors.initials: S
authors.lastname: Crowley
authors.affiliation: Florida Department of Health, Tallahassee, FL, United States.
authors.forename: Cristina
authors.initials: C
authors.lastname: Dusek
authors.affiliation: Texas Department of State Health Services, Austin, TX, United States.
authors.forename: Khalilah
authors.initials: K
authors.lastname: Loggins
authors.affiliation: Michigan Department of Community Health, Lansing, MI, United States.
authors.forename: Kenneth
authors.initials: K
authors.lastname: Onye
authors.affiliation: Immunization Services Division, National Center for Immunization and Respiratory Disease, Centers for Disease Control and Prevention, Atlanta, GA, United States.
authors.forename: Nancy
authors.initials: N
authors.lastname: Fenlon
authors.affiliation: Division 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.
authors.forename: Trudy V
authors.initials: TV
authors.lastname: Murphy
mesh_terms: D000293:Adolescent; D000328:Adult; D000917:Antibody Formation; D004279:DNA, Viral / Q000097:blood; D005260:Female; D006509:Hepatitis B / Q000517:prevention & control*; D006510:Hepatitis B Antibodies / Q000097:blood*; D006514:Hepatitis B Surface Antigens / Q000097:blood; D017325:Hepatitis B Vaccines / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D007115:Immunization Schedule; D007136:Immunoglobulins / Q000008:administration & dosage / Q000627:therapeutic use; D007223:Infant; D008875:Middle Aged; D015233:Models, Statistical; D015999:Multivariate Analysis; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000276:immunology; D012307:Risk Factors; D019562:Viral Load; D055815:Young Adult
chemical_list: D004279:DNA, Viral; D006510:Hepatitis B Antibodies; D006514:Hepatitis B Surface Antigens; D017325:Hepatitis B Vaccines; D007136:Immunoglobulins; C045213:hepatitis B hyperimmune globulin
keywords: Antibody response; Hepatitis B; Immunization; Perinatal; Vaccine