Clinical trial NCT02135666: Evaluation of the Long-term Hepatitis A and B Antibody Persistence in Healthy Adult Subjects, Primed 16 to 20 Years Earlier With GSK Biologicals' Combined Hepatitis A and B Vaccine, Twinrix® (SB208127) in Study HAB-084 (208127/084)
Official title: Long-term Hepatitis A and B Antibody Persistence in Healthy Adult Subjects, Primed 16 to 20 Years Earlier With GSK Biologicals' Combined Hepatitis A and B Vaccine, Twinrix® (SB208127) in Study HAB-084 (208127/084)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Hepatitis B
Hepatitis A
Keywords: Twinrix
Long-term follow-up
Persistence
Hepatitis A
Antibody
Immunity
Hepatitis B
Combination vaccine
Adult
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2014-05-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to assess the long-term persistence of immunity to hepatitis A and B in adults who were vaccinated 16-20 years earlier with the combined hepatitis A and hepatitis B vaccine, Twinrix.


Eligibility criteria: Inclusion Criteria:

* Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
* A male or female who received two/three doses of Twinrix according to his/her group allocation in study HAB-084 (208127/084), and received no further dose of any hepatitis A and/or B vaccine since then.
* Written informed consent obtained from the subject.

Exclusion Criteria:

* Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to study entry. Inhaled and topical steroids are allowed.
* Administration of long-acting immune-modifying drugs within six months prior to the study entry.
* Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product (pharmaceutical product or device).
* Administration of any hepatitis A and/or B vaccine at any time since completion of the primary vaccination series in HAB-084 (208127/084) study, including a challenge dose of the study vaccine, as a part of the study procedures, during the long-term persistence phase.
* Documented history of hepatitis A or B disease since completion of the primary vaccination series in HAB-084 (208127/084) study.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
* Administration of immunoglobulins within six months prior to study entry.

Primary outcomes:
measure: Immunogenicity with respect to components of the study vaccine in terms of antibody titres
timeFrame: At each long-term follow-up (LTFU) visit (16-20 years after the first dose of primary vaccination)
Secondary outcomes:
measure: Occurrence of Serious adverse events (SAEs)
timeFrame: During the entire study period (Year 16-20)
Other outcomes:
Locations:
city: Hradec Kralove
country: Czech Republic
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: