title: Hepatitis B Virus Revaccination With Standard Versus Pre-S Vaccine in Previously Immunized Patients With Celiac Disease.
abstract: OBJECTIVE
  Previous studies have suggested that hepatitis B virus (HBV) vaccines may be less immunogenic in individuals with celiac disease (CD). A pre-S vaccine (Sci-B-Vac) has demonstrated superior immunogenicity compared with standard HBV vaccines in several diseases. We compared the short-term immunogenicity of a pre-S vaccine with a HBV vaccine (Engerix B) for repeat vaccination of seronegative, previously immunized patients with CD.
  
  
  METHODS
  Participants were 1 to 18-year-old children with CD who despite standard HBV vaccines in infancy had nonprotective hepatitis B surface antibody (HBs-Ab) concentrations (≤10 mIU/mL). Patients were randomized to receive either Engerix B or pre-S vaccine. HBs-Ab concentrations were measured 1 month after the first dose. For those who had not responded after 1 dose, measurement was repeated after the third dose.
  
  
  RESULTS
  Children (n = 82) were analyzed (42 pre-S vaccine and 40 Engerix B). Baseline characteristics were similar for both groups, including gluten-free diet status. Both arms showed high response rates following the first injection: 41 (98%) versus 35 (87%) for pre-S vaccine and Engerix B recipients, respectively (P = 0.08). All other patients responded when measured after dose 3. HBs-Ab concentrations (mIU/mL) were higher in the pre-S vaccine group (median 925, interquartile range [IQR] 424-1000) than the Engerix B group (median 363, IQR 106-996, P = 0.005). Twenty (48%) of the pre-S vaccine recipients were "high responders" (>1000 mIU/mL) versus 10 (25%) in Engerix B recipients (P = 0.008).
  
  
  CONCLUSIONS
  Both vaccines elicited adequate booster responses in most previously vaccinated patients with CD with nonprotective HBs-Ab concentrations. Pre-S vaccine administration resulted in higher Hbs-Ab concentrations. Our data suggest that a single dose of either vaccine is sufficient to raise titers to protective levels in most patients with CD.
authors.affiliation: Pediatrics Department, Shaare Zedek Medical Center, Jerusalem.
authors.forename: Merav
authors.initials: M
authors.lastname: Heshin-Bekenstein
authors.forename: Dan
authors.initials: D
authors.lastname: Turner
authors.forename: Raanan
authors.initials: R
authors.lastname: Shamir
authors.forename: Maskit
authors.initials: M
authors.lastname: Bar-Meir
authors.forename: Ron
authors.initials: R
authors.lastname: Dagan
authors.forename: Noam
authors.initials: N
authors.lastname: Zevit
authors.forename: Ari
authors.initials: A
authors.lastname: Silbermintz
mesh_terms: D000046:Academic Medical Centers; D000293:Adolescent; D000917:Antibody Formation / Q000187:drug effects; D036022:Capsid Proteins / Q000009:adverse effects / Q000235:genetics / Q000378:metabolism / Q000627:therapeutic use*; D002446:Celiac Disease / Q000097:blood / Q000150:complications / Q000276:immunology*; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D006509:Hepatitis B / Q000150:complications / Q000276:immunology / Q000517:prevention & control*; D006510:Hepatitis B Antibodies / Q000032:analysis*; D006514:Hepatitis B Surface Antigens / Q000009:adverse effects / Q000235:genetics / Q000378:metabolism / Q000627:therapeutic use*; D017325:Hepatitis B Vaccines / Q000009:adverse effects / Q000235:genetics / Q000378:metabolism / Q000627:therapeutic use*; D006801:Humans; D007110:Immunity, Active / Q000187:drug effects*; D007117:Immunization, Secondary; D016867:Immunocompromised Host / Q000187:drug effects; D007223:Infant; D007557:Israel; D059012:Lost to Follow-Up; D011498:Protein Precursors / Q000009:adverse effects / Q000235:genetics / Q000378:metabolism / Q000627:therapeutic use*; D014614:Vaccines, Synthetic / Q000009:adverse effects / Q000235:genetics / Q000378:metabolism / Q000627:therapeutic use
chemical_list: D036022:Capsid Proteins; C075654:Engerix-B; D006510:Hepatitis B Antibodies; D006514:Hepatitis B Surface Antigens; D017325:Hepatitis B Vaccines; C000608755:Pre-S vaccine; D011498:Protein Precursors; D014614:Vaccines, Synthetic; C050806:presurface protein 1, hepatitis B surface antigen; C050807:presurface protein 2, hepatitis B surface antigen