Immune Response to Hepatitis B Vaccine Challenge Dose in Subjects Who Received a Primary Neonatal Hepatitis B Vaccine.

Summary

The current study will evaluate immunological memory to hepatitis B antigen in subjects who received primary neonatal vaccination of hepatitis B vaccine (Engerix™-B ), 20 years ago in the primary study and who have anti-HBs antibody concentrations \< pre-defined cut-off values at the previous long-term time point. All participating subjects will receive a challenge dose of hepatitis B vaccine. Subjects will be aged approximately 20-21 years at the time of this study. No new subjects will be recruited in this long-term follow-up study. Blood sampling will be done one month after the administration of the challenge dose. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Timeline

Start

2007-04

Primary completion

2008-01

Completion

2008-01

Publications

• Background Poovorawan Y, Chongsrisawat V, Theamboonlers A, Bock HL, Leyssen M, Jacquet JM. Persistence of antibodies and immune memory to hepatitis B vaccine 20 years after infant vaccination in Thailand. Vaccine. 2010 Jan 8;28(3):730-6. doi: 10.1016/j.vaccine.2009.10.074. Epub 2009 Nov 3.
• Background Poovorawan Y, Chongsrisawat V, Theamboonlers A, Leroux-Roels G, Kuriyakose S, Leyssen M, Jacquet JM. Evidence of protection against clinical and chronic hepatitis B infection 20 years after infant vaccination in a high endemicity region. J Viral Hepat. 2011 May;18(5):369-75. doi: 10.1111/j.1365-2893.2010.01312.x.
• Background Poovorawan Y et al. 20-year follow-up of immunogenicity and efficacy of infant hepatitis B vaccination. Abstract presented at the 6th World Congress of the World Society for Pediatric Infectious Diseases (WSPID). Buenos Aires, Argentina, 18-22 November 2009.
• Background Poovorawan Y et al. 20-year persistence of immune response to infant hepatitis B vaccination in a high endemicity region. Abstract presented at the 13th International Symposium on Viral Hepatitis and Liver Disease (ISVHLD), Washington DC, US, 20-24 March 2009.

Drugs

Indications