Immunogenicity and Safety of a Novel Adjuvanted HBV Vaccine in Pre-liver Transplant Patients 18 Years of Age

NCT00697554 | Completed Phase 3

• 1 other identifier: 208129/036
• Study Type: interventional
• Target: 93
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to enroll pre-liver transplant patients who will be vaccinated with either the novel adjuvanted HBV vaccine or double doses of Engerix™-B. The immunogenicity and safety of the novel adjuvanted vaccine will be compared to Engerix™-B as the control vaccine

Conditions

Hepatitis B

Keywords

Hepatitis B; Adjuvanted hepatitis B vaccine

Outcome Measures

Primary Outcomes (1)

• Anti-HBs antibody concentrations

  At Day 28

Secondary Outcomes (4)

• Occurrence, intensity and relationship to vaccination of solicited local and general signs and symptoms

  During a 4 day follow-up period after vaccination

• Occurrence, intensity and relationship to vaccination of unsolicited symptoms

  During a 30 day follow-up period after vaccination

• Occurrence, intensity and relationship to vaccination of serious adverse events (SAEs)

  During the study period

• Anti-HBs antibody concentrations

  At d21, d28, d56, M6-12, 1M after booster dose

Study Arms (2)

Group A

EXPERIMENTAL

Biological: HBV-MPL vaccine 208129

Group B

ACTIVE COMPARATOR

Biological: Engerix™-B

Interventions

HBV-MPL vaccine 208129 BIOLOGICAL

2-dose primary vaccination followed by 1 booster vaccination by intramuscular injection

Group A

Engerix™-B BIOLOGICAL

3-dose primary vaccination followed by 1 booster vaccination by intramuscular injection of double doses

Also known as: HBV-MPL vaccine 208129

Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A male or female ≥ 18 years of age at the time of the first vaccination.
• Written informed consent obtained from the subject.
• Seronegative for anti-HBs-antibodies, anti-HBc-antibodies \& HBsAg.
• If the subject is female, she must be of non-childbearing potential or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series.
• Documented case of liver failure, such that the patient will require an eventual liver transplant

You may not qualify if:

• Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) during the study period or within 30 days preceding the first dose of study vaccine.
• Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of vaccine and ending 30 days after.
• Previous vaccination against hepatitis B (whether or not a non-responder to vaccination).
• Previous vaccination with an adjuvant system containing MPL®.
• History of hepatitis B infection.
• Known exposure to hepatitis B virus within 6 weeks.
• Previously confirmed human immunodeficiency virus (HIV) infection.
• A family history of congenital or hereditary immunodeficiency.
• Immunosuppression caused by the administration of parenteral steroids or chemotherapy.
• Suspected or confirmed multiple sclerosis in the subject (applicable to Centres 011, 012, 013 and 014/ France only).
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
• Acute, intercurrent disease at the time of enrollment.
• Oral/axillary temperature of ≥ 37.5°C (≥ 99.5°F).
• Administration of immunoglobulins and/or any blood products within one month preceding the first dose of study vaccine or planned administration/ administration during the study period.
• Pregnant or lactating female

Sponsors & Collaborators

• GlaxoSmithKline: lead

Related Publications (3)

• Nevens F, Zuckerman JN, Burroughs AK, Jung MC, Bayas JM, Kallinowski B, Rivas EF, Duvoux C, Neuhaus P, Saliba F, Buti M, Zarski JP, Pons F, Vanlemmens C, Hamtiaux V, Stoffel M. Immunogenicity and safety of an experimental adjuvanted hepatitis B candidate vaccine in liver transplant patients. Liver Transpl. 2006 Oct;12(10):1489-95. doi: 10.1002/lt.20836.

  PMID: 16964595 BACKGROUND

• Nevens F et al. Immunogenicity and safety of a novel adjuvanted hepatitis B candidate vaccine in liver transplant patients. Abstract presented at the 39th Annual Meeting of the European Association for the Study of Liver (EASL), Berlin, Germany, 14-18 April 2004.

  BACKGROUND

• Verstraeten T, Descamps D, David MP, Zahaf T, Hardt K, Izurieta P, Dubin G, Breuer T. Analysis of adverse events of potential autoimmune aetiology in a large integrated safety database of AS04 adjuvanted vaccines. Vaccine. 2008 Dec 2;26(51):6630-8. doi: 10.1016/j.vaccine.2008.09.049.

  PMID: 18845199 BACKGROUND

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Hepatitis B

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

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2008
• First Posted: June 16, 2008
• Study Start: January 1, 2000
• Primary Completion: May 1, 2002
• Last Updated: September 9, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will share