NCT01037114

Long-term Persistence Study in Healthy Adults Previously Vaccinated With Twinrix Adult

An Open Single Centre Study to Evaluate the Long-term Antibody Persistence and Immune Memory Between 16 and 20 Years After the Primary Study HAB-032 (208127/022) in Which Healthy Adults Were Vaccinated With Twinrix Adult Following a Three-dose Schedule.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: —
• Healthy volunteers: Accepted

Summary

This study will evaluate the persistence of the immune response to HAV (hepatitis A virus) antigens and HBs (hepatitis B surface) antigens in healthy adults previously vaccinated with Twinrix Adult in the primary study, HAB-032 (208127/022). The subjects will be invited for blood sampling 16, 17, 18, 19 and 20 years after the primary vaccination to evaluate the antibody persistence. For subjects in whom low circulating antibodies are detected, the presence of immune memory against hepatitis A \& B antigens will be investigated by the administration of a challenge dose of the appropriate vaccine (Havrix and/or Engerix-B) at the next planned visit. No new subjects will be recruited during this study.

Conditions

• Hepatitis A
• Hepatitis B

Interventions

Type	Name	Description
PROCEDURE	Blood sampling	Blood sampling at Year 16, 17, 18, 19 and 20 and at the time of challenge dose administration and 14 days and one month after challenge dose administration (if challenge dose needed).
BIOLOGICAL	Engerix-B	Engerix-B will be administered to subjects who are not seroprotected against hepatitis B.
BIOLOGICAL	Havrix	Havrix will be administered to subjects who are seronegative for anti-HAV antibodies.

Timeline

• Start date: 2010-01-27
• Primary completion: 2014-02-28
• Completion: 2014-02-28
• First posted: 2009-12-21
• Last updated: 2019-02-01
• Results posted: 2011-04-27

Locations

1 site across 1 country: Belgium