title: Persistence of antibodies 20 y after vaccination with a combined hepatitis A and B vaccine.
abstract: Vaccination is the most effective and well-tolerated method of conferring long-term protection against hepatitis A and B viruses (HAV; HBV). Long-term studies are required to characterize the duration of protection and need for boosters. Following primary immunization of 150 and 157 healthy adults with 3-doses of combined hepatitis A/hepatitis B vaccine (HAB; Twinrix™, GSK Vaccines, Belgium) at 0-1-6 months in 2 separate studies, we measured vaccine-induced antibody persistence against HAV and HBV annually for 20 y (Study A: NCT01000324; Study B: NCT01037114). Subjects with circulating anti-HAV antibodies < 15 mIU/mL or with anti-hepatitis B surface antigen < 10 mIU/mL were offered an additional monovalent hepatitis A and/or B vaccine dose (Havrix™/Engerix™-B, GSK Vaccines, Belgium). Applying the immunogenicity results from these studies, mathematical modeling predicted long-term persistence. After 20 y, 18 and 25 subjects in studies A and B, respectively, comprised the long-term according-to-protocol cohort for immunogenicity; 100% and 96.0% retained anti-HAV antibodies ≥ 15 mIU/mL, respectively; 94.4% and 92.0% had anti-HBs antibodies ≥ 10 mIU/mL, respectively. Between Years 16-20, 4 subjects who received a challenge dose of monovalent hepatitis A vaccine (N = 2) or hepatitis B vaccine (N = 2), all mounted a strong anamnestic response suggestive of immune memory despite low antibody levels. Mathematical modeling predicts that 40 y after vaccination ≥ 97% vaccinees will maintain anti-HAV ≥ 15 mIU/mL and ≥ 50% vaccinees will retain anti-HBs ≥ 10 mIU/mL. Immunogenicity data confirm that primary immunization with 3-doses of HAB induces persisting anti-HAV and anti-HBs specific antibodies in most adults for up to 20 y; mathematical modeling predicts even longer-term protection.
authors.affiliation: a Centre for the Evaluation of Vaccination , Vaccine and Infectious Disease Institute, University of Antwerp , Antwerp , Belgium.
authors.forename: Pierre
authors.initials: P
authors.lastname: Van Damme
authors.affiliation: b Center for Vaccinology, Ghent University Hospital , Ghent , Belgium.
authors.forename: Geert
authors.initials: G
authors.lastname: Leroux-Roels
authors.affiliation: c GSK Pharmaceuticals , Mumbai , India.
authors.forename: P
authors.initials: P
authors.lastname: Suryakiran
authors.affiliation: d GSK Vaccines , Wavre , Belgium.
authors.forename: Nicolas
authors.initials: N
authors.lastname: Folschweiller
authors.affiliation: d GSK Vaccines , Wavre , Belgium.
authors.forename: Olivier
authors.initials: O
authors.lastname: Van Der Meeren
mesh_terms: D000328:Adult; D001530:Belgium / Q000453:epidemiology; D015331:Cohort Studies; D005260:Female; D005500:Follow-Up Studies; D006506:Hepatitis A / Q000453:epidemiology / Q000517:prevention & control; D035922:Hepatitis A Antibodies / Q000097:blood* / Q000276:immunology / Q000302:isolation & purification; D022362:Hepatitis A Vaccines / Q000008:administration & dosage / Q000276:immunology*; D006509:Hepatitis B / Q000453:epidemiology / Q000517:prevention & control; D006510:Hepatitis B Antibodies / Q000097:blood* / Q000276:immunology / Q000302:isolation & purification; D017325:Hepatitis B Vaccines / Q000008:administration & dosage / Q000276:immunology*; D006801:Humans; D007117:Immunization, Secondary; D000071497:Immunogenicity, Vaccine; D007156:Immunologic Memory; D008297:Male; D008875:Middle Aged; D013997:Time Factors; D014611:Vaccination / Q000379:methods; D017778:Vaccines, Combined / Q000008:administration & dosage / Q000276:immunology
chemical_list: D035922:Hepatitis A Antibodies; D022362:Hepatitis A Vaccines; D006510:Hepatitis B Antibodies; D017325:Hepatitis B Vaccines; D017778:Vaccines, Combined
keywords: Hepatitis A; Hepatitis B; Immune memory; Long-term; Persistence; Vaccination