A phase IV, open-label, multi-centre study to assess the long-term persistence of hepatitis A and B antibodies 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).

• Register: EUCTR
• Last refreshed on: 16 August 2016
• Main ID: EUCTR2013-004586-13-BE
• Date of registration: 04/04/2014
• Prospective Registration: Yes
• Primary sponsor: GlaxoSmithKline Biologicals
• Public title: A phase IV, open-label, multi-centre study to assess the long-term persistence of hepatitis A and B antibodies 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).
• Scientific 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). - HAB-171 EXT 084 Y16-20
• Date of first enrolment: 28/04/2014
• Target sample size: 180
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-004586-13
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

Belgium

Contacts

• Name: Clinical Disclosure Advisor
• Affiliation: GlaxoSmithKline Biologicals

• Name: Clinical Disclosure Advisor
• Affiliation: GlaxoSmithKline Biologicals

Key inclusion & exclusion 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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 180
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Virus Diseases [C02]

Healthy volunteers (Vaccination against hepatitis A and hepatitis B in healthy adults)
MedDRA version: 16.1 Level: SOC Classification code 10021881 Term: Infections and infestations System Organ Class: 10021881 - Infections and infestations

Intervention(s)

Trade Name: TwinrixTM Adult
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Hepatitis A (inactivated)
Current Sponsor code: HAV Antigen
Other descriptive name: HEPATITIS A VIRUS ANTIGEN (INACTIVATED)
Concentration unit: ELISA unit/dose enzyme-linked immunosorbent assay unit/dose
Concentration type: equal
Concentration number: 720-
INN or Proposed INN: hepatitis B Surface Antigen
Current Sponsor code: HBsAg
Other descriptive name: HEPATITIS B SURFACE ANTIGEN
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 20-

Trade Name: Twinrix TM Paediatric
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: HEPATITIS A VIRUS ANTIGEN (INACTIVATED)
Current Sponsor code: HAV antigen
Other descriptive name: HEPATITIS A VIRUS ANTIGEN (INACTIVATED)
Concentration unit: ELISA unit/dose enzyme-linked immunosorbent assay unit/dose
Concentration type: equal
Concentration number: 360-
INN or Proposed INN: HEPATITIS B SURFACE ANTIGEN
Other descriptive name: HEPATITIS B SURFACE ANTIGEN
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 10-

Primary Outcome(s)

Primary end point(s): Immunogenicity with respect to components of the study vaccine in terms of antibody titres.
?Anti-HAV seropositivity status and Geometric Mean Concentration (GMC),
?Anti-HBs seropositivity status, seroprotection status and GMC.

Main Objective: •To evaluate the persistence of anti-HBs antibodies in terms of seroprotection rate and geometric mean concentrations (GMCs), 16 to 20 years after the first vaccine dose.
•To evaluate the persistence of anti-HAV antibodies in terms of seropositivity rate and GMCs, 16 to 20 years after the first vaccine dose.

Secondary Objective: •Occurrence of serious adverse events (SAEs) related to study participation, or to the study vaccine administered in the primary study HAB-084 (208127/084), during the entire study period.

Timepoint(s) of evaluation of this end point: At each long-term follow-up (LTFU) visit (16-20 years after the first dose of primary vaccination).

Secondary Outcome(s)

Secondary end point(s): Occurrence of Serious adverse events (SAEs).
-Occurrence of SAEs related to study participation or to the study vaccine administered in the primary study HAB-084 (208127/084).

Timepoint(s) of evaluation of this end point: During the entire study period (Year 16-20).

Secondary ID(s)

117307

Source(s) of Monetary Support

GlaxoSmithKline Biologicals