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

BMC Infectious Diseases

Research Article

Anne-Diane Kervyn¹  Andrew Brockway²  Su-Peing Ng³  Maarten Leyssen⁴  Jeanne-Marie Jacquet⁴  Sherine Kuriyakose⁵  Anna Moiseeva⁶  Igor Marichev⁶  Robert Booy⁷  Pierre Van Damme⁸ 

[1] Centre de Santé UCL, Clos Chapelle-aux-Champs, 30/39 1200 Brussels, Belgium;GlaxoSmithKline Biologicals, Melbourne Victoria, Australia;GlaxoSmithKline Biologicals, Singapore;GlaxoSmithKline Biologicals, Wavre, Belgium;GlaxoSmithKline Pharmaceuticals Ltd., Bangalore, India;Ministry of Health, Centre of Immunobiological Products, Kiev, Ukraine;National Centre for Immunisation Research and Surveillance, The Children's Hospital at Westmead, NSW 2145, Australia; and The University of Sydney, NSW, Australia;Professor, Faculty of Medicine, Vaccine & Infectious Disease Institute (WHO Collaborating Centre), Centre for the Evaluation of Vaccination, Antwerpen, Belgium;

关键词: Challenge Dose;    Primary Vaccination;    Immune Memory;    Seroprotection Rate;    Paediatric Formulation;   

DOI  :  10.1186/1471-2334-10-357

 received in 2010-07-28, accepted in 2010-12-20,  发布年份 2010

来源: Springer

【 摘 要 】

BackgroundThe 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.MethodsA 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.ResultsAt 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.ConclusionThe 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 registrationClinical Trials NCT00343915, NCT00524576

【 授权许可】

CC BY   
© Van Damme et al; licensee BioMed Central Ltd. 2010. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.