Five years follow-up following two or three doses of a hepatitis B vaccine in adolescents aged 11-15 years: a randomised controlled study

Abstract

Background: The standard three-dose schedule of hepatitis B vaccines is frequently not completed, especially in adolescents. A primary study has confirmed the equivalence of a two-dose schedule of an Adult formulation of hepatitis B vaccine [Group HBV_2D] to a three-dose schedule of a Paediatric formulation in adolescents (11-15 years) [Group HBV_3D]. This follow-up study evaluated the five year persistence of antibody response and immune memory against the hepatitis B surface (anti-HBs) antigens five years after completion of primary vaccination.

Methods: A total of 234 subjects returned at the Year 5 time point, of which 144 subjects received a challenge dose of hepatitis B vaccine. Blood samples were collected yearly and pre- and post-challenge dose to assess anti-HBs antibody concentrations.

Results: At the end of five years, 79.5% (95% confidence interval [CI]: 71.7 - 86.1) and 91.4% (95% CI: 82.3 - 96.8) of subjects who received the two-dose and three-dose schedules, respectively had anti-HBs antibody concentrations ≥ 10 mIU/mL. Post-challenge dose, all subjects had anti-HBs antibody concentration ≥ 10 mIU/mL and >94% subjects had anti-HBs antibody concentration ≥ 100 mIU/mL. All subjects mounted a rapid anamnestic response to the challenge dose. Overall, the challenge dose was well-tolerated.

Conclusion: The two-dose schedule of hepatitis B vaccine confers long-term immunogenicity and shows evidence of immune memory for at least five years following vaccination.

Trial registration: Clinical Trials NCT00343915, NCT00524576.

Figure 1

CONSORT diagram.

Figure 2

Percentage of subjects with anti-HBs concentration ≥10 mIU/mL at all long-term follow-up time points (Long-term ATP cohort for immunogenicity).

Figure 3

Evolution of anti-HBs antibody geometric mean concentrations (GMCs) during the five years follow-up period (Long-term ATP cohort for immunogenicity) and during the challenge phase (ATP cohort for immunogenicity).