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)

NCT02135666 | Withdrawn Phase 4

• 2 other identifiers: 1173072013-004586-13
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis B; Hepatitis A

Keywords

Twinrix; Long-term follow-up; Persistence; Hepatitis A; Antibody; Immunity; Hepatitis B; Combination vaccine; Adult

Outcome Measures

Primary Outcomes (1)

• Immunogenicity with respect to components of the study vaccine in terms of antibody titres

  At each long-term follow-up (LTFU) visit (16-20 years after the first dose of primary vaccination)

Secondary Outcomes (1)

• Occurrence of Serious adverse events (SAEs)

  During the entire study period (Year 16-20)

Study Arms (2)

2-dose Primed Group

EXPERIMENTAL

Adolescent subjects in this group received 2 doses of Twinrix Adult (720/20) (licensed as Ambirix in the EU) according to a 0, 6 months schedule in the primary study HAB-084 (208127/084).

Procedure: Blood sampling

3-dose Primed Group

EXPERIMENTAL

Adolescent subjects in this group received 3 doses of Twinrix Junior (360/10) according to a 0, 1, 6 months schedule in the primary study HAB-084 (208127/084).

Procedure: Blood sampling

Interventions

Blood sampling PROCEDURE

At Years 16 - 20 after first dose of the primary vaccination in HAB-084 (208127/084) study.

2-dose Primed Group; 3-dose Primed Group

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Hradec Králové, 500 01, Czechia

Location

MeSH Terms

Conditions

Hepatitis B; Hepatitis A

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2014
• First Posted: May 12, 2014
• Study Start: May 1, 2015
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: November 18, 2015

Record last verified: 2015-11

Locations

CZ (1)