Immunity to hepatitis A and B persists for at least 15 years after immunisation of adolescents with a combined hepatitis A and B vaccine. Issue 24 (23rd May 2016)

• Record Type: Journal Article
• Authors: Beran, Jiri; Van Der Meeren, Olivier; Leyssen, Maarten; D'silva, Priya
• Is Part Of: Vaccine. Volume 34:Issue 24(2016)
• Page Start: 2686
• Page End: 2691
• Publication Date: 2016-05-23
• Subjects: HAV hepatitis A virus -- HBV hepatitis B virus -- HBs hepatitis B surface antigen -- anti-HBs antibodies to hepatitis B surface antigen -- anti-HAV antibodies to hepatitis A virus -- ATP according-to-protocol -- CI confidence interval -- CLIA chemiluminescence immunosorbent assay -- ELISA enzyme-linked immunosorbent assay -- GMC geometric mean concentration -- IU International units -- LT-ATP long-term-according to protocol -- EL.U ELISA Units; Anamnestic response -- Anti-HAV antibody -- Anti-HBs antibody -- Challenge dose -- Combined hepatitis A and B vaccine -- Long-term follow-up; Vaccines -- Periodicals; 615.372
• DOI: 10.1016/j.vaccine.2016.04.033
• Languages: English
• ISSNs: 0264-410X

Abstract

Highlights: 2- and 3-dose combined hepatitis A and B vaccination imparts immunity for ≥15 years. All subjects remained seropositive for anti-HAV; 81% were protected for anti-HBs. One-month post-challenge, all except one subject in the 3-dose group showed a robust anamnestic response. High anamnestic response suggests no need for booster dosing for ≥15 years. Abstract: Background: The exact duration of antibody persistence to hepatitis A and B and the need for booster dosing following primary immunisation remains undefined. A long-term study was designed to follow antibody persistence and immune memory on an annual basis for up to 15 years following vaccination during adolescence. Methods: Subjects received a combined hepatitis A and B vaccine ( Twinrix ™, GSK Vaccines, Belgium) at 12–15 years of age, either as 2-dose of the adult formulation or 3-dose of the paediatric formulation. Blood samples were taken every year thereafter to assess antibody persistence and immune memory to hepatitis A and B. Antibodies to hepatitis A virus (anti-HAV) and hepatitis B surface antigen (anti-HBs) were measured at Years 11–15. At Year 15 immune memory was further assessed by measuring the anamnestic response to a challenge dose of the monovalent vaccine, which was administered to subjects whose antibody concentrations fell below the pre-defined cut-offs (anti-HAV: <15 mIU/mL; anti-HBs: <10 mIU/mL). Results: 209 subjects returned for follow-up at Year 15 of whom 162 were included in the long-term according-to-protocol immunogenicity cohort. All subjects remained seropositive for anti-HAV antibodies, while 81.1% and 81.8% still had anti-HBs antibodies ≥10 mIU/mL in the 2- and 3-dose groups, respectively. Following hepatitis B vaccine challenge dose administration to 19 subjects, all except one in the 3-dose group, mounted a robust anamnestic response. The safety and reactogenicity profile of the hepatitis B challenge was consistent with previous experience. Conclusion: Immunity to hepatitis A and B persists 15 years after adolescent vaccination with a combined hepatitis A and B vaccine. Highly effective anamnestic response indicates that a booster dose should not be required for 15 years after primary vaccination. Trial registration: http://www.clinicaltrials.gov NCT00875485 .