Five years follow-up following two or three doses of a hepatitis B vaccine in adolescents aged 11-15 years: a randomised controlled study
1 Professor, Faculty of Medicine, Vaccine & Infectious Disease Institute (WHO Collaborating Centre), Centre for the Evaluation of Vaccination, Antwerpen, Belgium
2 Ministry of Health, Centre of Immunobiological Products, Kiev, Ukraine
3 Centre de Santé UCL, Clos Chapelle-aux-Champs, 30/39 1200 Brussels, Belgium
4 National Centre for Immunisation Research and Surveillance, The Children's Hospital at Westmead, NSW 2145, Australia; and The University of Sydney, NSW, Australia
5 GlaxoSmithKline Pharmaceuticals Ltd., Bangalore, India
6 GlaxoSmithKline Biologicals, Melbourne Victoria, Australia
7 GlaxoSmithKline Biologicals, Singapore
8 GlaxoSmithKline Biologicals, Wavre, Belgium
BMC Infectious Diseases 2010, 10:357 doi:10.1186/1471-2334-10-357Published: 20 December 2010
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.
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.
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.
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.
Clinical Trials NCT00343915, NCT00524576