Clinical trial NCT00289718: Long-Term Immune Persistence of GSK Biologicals' Combined Hepatitis A & B Vaccine Injected According to a 0,1,6 Month Schedule
Official title: Long-Term Persistence Follow-up Study to Evaluate the Immune Persistence of GSK Biologicals' Combined Hepatitis A / Hepatitis B Vaccine in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis B
Hepatitis A
Keywords: Combined Hepatitis A and B vaccine
Hepatitis A
Hepatitis B
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-02-10
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The aim of this study is to evaluate the long-term persistence of hepatitis A and B antibodies at Years 11, 12, 13, 14 and 15 years after subjects received their first dose of a 3 dose vaccination schedule of combined hepatitis A/hepatitis B vaccine. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

This protocol posting deals with objectives \& outcome measures of the extension phase at year 11 to 15.

Detailed description: This is a long-term follow-up study at Years 11, 12, 13, 14 and 15 after primary vaccination with GSK Biologicals' hepatitis A/hepatitis B vaccine (three-dose schedule, 3 different lots). To evaluate the long-term antibody persistence, volunteers will be bled at Years 11, 12, 13, 14 and 15 after the first vaccine dose of the primary vaccination course to determine their anti-HAV and anti-HBs antibody concentrations.

No additional subjects will be recruited during the course of this long-term study.

If a subject has become seronegative for anti-HAV antibodies or lost anti-HBs seroprotection concentrations at the long-term blood sampling time point (i.e. Years 11, 12, 13, 14 or 15), he/ she will be offered an additional vaccine dose.

Eligibility criteria: Inclusion Criteria:

* Subjects participating in this study should have received three-dose primary vaccination with combined hepatitis A/hepatitis B vaccine in the primary study.
* Written informed consent will be obtained from each subject before the blood sampling visit of each year

Primary outcomes:
measure: Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration
timeFrame: At Years 11, 12, 13, 14, and 15 after the first vaccine dose of the 3-dose primary vaccination
measure: Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.
timeFrame: During the 4-day (Day 0-3) follow-up period after additional HBV vaccination
measure: Number of Subjects Seropositive for Anti-HAV Antibodies
timeFrame: At Years 11, 12, 13, 14, and 15 after the first vaccine dose of the 3-dose primary vaccination
measure: Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration
timeFrame: At Years 11, 12, 13, 14, and 15 after the first vaccine dose of the 3-dose primary vaccination
measure: Number of Subjects Seropositive for Anti-HB Antibodies
timeFrame: At Years 11, 12, 13, 14, and 15 after the first vaccine dose of the 3-dose primary vaccination
measure: Number of Subjects Seroprotected for Anti-HBs Antibodies.
timeFrame: At Years 11, 12, 13, 14, and 15 after the first vaccine dose of the 3-dose primary vaccination
measure: Number of Subjects Reporting Serious Adverse Events (SAE)
timeFrame: During the follow-up period after additional vaccination (minimum 30 days)
measure: Anti-Hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration
timeFrame: Before the additional dose and 1 month after the additional dose
measure: Number of Subjects Reporting Any Solicited General Symptoms.
timeFrame: During the 4-day (Day 0-3) follow-up period after additional HBV vaccination
measure: Number of Subjects Reporting Unsolicited Adverse Events (AE)
timeFrame: During the 30-day follow-up period after additional vaccination
measure: Number of Subjects Reporting Serious Adverse Events (SAEs)
timeFrame: At Years 11, 12, 13, 14, and 15 after the first vaccine dose of the 3-dose primary vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Van Damme P, Leroux-Roels G, Law B, Diaz-Mitoma F, Desombere I, Collard F, Tornieporth N, Van Herck K. Long-term persistence of antibodies induced by vaccination and safety follow-up, with the first combined vaccine against hepatitis A and B in children and adults. J Med Virol. 2001 Sep;65(1):6-13.
citation: Van Damme P, Leroux-Roels G, Crasta P, Messier M, Jacquet JM, Van Herck K. Antibody persistence and immune memory in adults, 15 years after a three-dose schedule of a combined hepatitis A and B vaccine. J Med Virol. 2012 Jan;84(1):11-7. doi: 10.1002/jmv.22264. Epub 2011 Nov 3.
citation: Van Herck K, Leroux-Roels G, Van Damme P, Srinivasa K, Hoet B. Ten-year antibody persistence induced by hepatitis A and B vaccine (Twinrix) in adults. Travel Med Infect Dis. 2007 May;5(3):171-5. doi: 10.1016/j.tmaid.2006.07.003. Epub 2006 Sep 20.