Immunogenicity and Safety of a Novel Adjuvanted HBV Vaccine in Pre-Liver Transplant Patients 18 Years of Age - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00697554

Purpose

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

Condition	Intervention	Phase
Hepatitis B	Biological: HBV-MPL vaccine 208129 Biological: Engerix™-B	Phase III

MedlinePlus related topics: Hepatitis Hepatitis B Liver Transplantation

Drug Information available for: Hepatitis B Vaccines

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	Study to Compare the Immunogenicity and Safety of GSK Biologicals' Novel Adjuvanted HBV Vaccine (0, 21-Day Schedule) to a Double Dose of Engerix™ -B (0, 7, 21-Day Schedule), in Pre-Liver Transplant Patients ≥ 18 y, Boosted at Month 6-12

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Anti-HBs antibody concentrations [ Time Frame: At Day 28 ]

Secondary Outcome Measures:

Occurrence, intensity and relationship to vaccination of solicited local and general signs and symptoms [ Time Frame: During a 4 day follow-up period after vaccination ]
Occurrence, intensity and relationship to vaccination of unsolicited symptoms [ Time Frame: During a 30 day follow-up period after vaccination ]
Occurrence, intensity and relationship to vaccination of serious adverse events (SAEs) [ Time Frame: During the study period ]
Anti-HBs antibody concentrations [ Time Frame: At d21, d28, d56, M6-12, 1M after booster dose ]

Enrollment:	93
Study Start Date:	January 2000
Primary Completion Date:	May 2002 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group A: Experimental	Biological: HBV-MPL vaccine 208129 2-dose primary vaccination followed by 1 booster vaccination by intramuscular injection
Group B: Active Comparator	Biological: Engerix™-B 3-dose primary vaccination followed by 1 booster vaccination by intramuscular injection of double doses

Detailed Description:

At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00697554

Locations

Belgium
GSK Clinical Trials Call Center
Leuven, Belgium
France
GSK Clinical Trials Call Center
Villejuif, France
Germany
GSK Clinical Trials Call Center
Heidelberg, Germany
Spain
GSK Clinical Trials Call Center
Barcelona, Spain
United Kingdom
GSK Clinical Trials Call Center
London, United Kingdom, NW32PF

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

Clinical Trials

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Isabelle Harpigny )
Study ID Numbers:	208129/036
Study First Received:	June 12, 2008
Last Updated:	June 13, 2008
ClinicalTrials.gov Identifier:	NCT00697554
Health Authority:	Germany: Ministry of Health; United Kingdom: National Health Service; Belgium: Institutional Review Board; Spain: Ministry of Health; France: Ministry of Health

Keywords provided by GlaxoSmithKline:

Hepatitis B
Adjuvanted hepatitis B vaccine

Study placed in the following topic categories:

Virus Diseases
Hepatitis
Liver Diseases
Digestive System Diseases

Hepatitis B
Hepatitis, Viral, Human
DNA Virus Infections

Additional relevant MeSH terms:

Hepadnaviridae Infections

ClinicalTrials.gov processed this record on January 15, 2009