Immunogenicity and Safety of an Adjuvanted HBV Vaccine Compared to Engerix™-B, in a Non-Responder Population ≥ 15y - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00698061

Purpose

Subjects who had not responded to previous hepatitis B vaccination were vaccinated with either the adjuvanted HBV-MPL vaccine or Engerix™-B vaccine according to a three-dose vaccination schedule (0, 1, 2 months) and boosted at Month 12 as per their group allocation. The immunogenicity and safety of the HBV-MPL vaccine were compared with the control vaccine, Engerix™-B.

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

MedlinePlus related topics: Hepatitis Hepatitis B

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind (Subject), Parallel Assignment, Safety/Efficacy Study
Official Title:	A Study to Compare the Immunogenicity and Safety of GSK Biologicals Adjuvanted HBV Vaccine to Engerix™-B, in a Non-Responder Population ≥ 15 Years of Age, When Administered Intramuscularly, According to a 0, 1, 2, 12 Month Schedule

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Anti-HBs antibody concentrations [ Time Frame: Months 1, 2 and 3 ]

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 signs and 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, up to and including 6 months post-vaccination ]
Anti-HBs antibody concentrations in all subjects [ Time Frame: Months 1, 2, 3, 12 and 13 ]

Enrollment:	145
Study Start Date:	December 1999
Primary Completion Date:	May 2001 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group A: Experimental	Biological: HBV-MPL vaccine 208129 3-dose primary vaccination and booster vaccination by intramuscular injection
Group B: Active Comparator	Biological: Engerix™-B 3-dose primary vaccination and booster vaccination by intramuscular injection

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:	15 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

At study entry:

A male or female ≥ 15 years of age at the time of the first vaccination.
Free of obvious health problems as established by medical history and clinical examination before entering into the study.
Written informed consent obtained from the subject.
Documented non-response to previous hepatitis B vaccination within 6 months after having received a full vaccination course (i.e. ≥ 3 doses of a hepatitis B vaccine)
If the subject is female, she must be of non-childbearing potential, or, if of childbearing potential, she must be abstinent or use adequate contraceptive precautions for one month prior to enrollment and up to two months after the last vaccination.

Before booster dose at month 12:

Additional written informed consent covering the booster administration and blood samples at months 12 and 13 must be obtained from the subject.
If the subject is female, she must be of non-childbearing potential, or, if of childbearing potential, she must be abstinent or use adequate contraceptive precautions for one month prior to and up to two months after the administration of the booster dose

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.
Known exposure to hepatitis B within 6 weeks.
History of hepatitis B infection.
Confirmed human immunodeficiency virus (HIV) infection.
A family history of congenital or hereditary immunodeficiency.
History of allergic disease/reactions likely to be exacerbated by any component of the vaccine.
Acute disease at the time of enrollment.
Hepatomegaly, right upper quadrant abdominal pain or tenderness.
Administration of immunoglobulins and/or any blood products within the three months 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: NCT00698061

Locations

Belgium
GSK Clinical Trials Call Center
Brussels, Belgium
Spain
GSK Clinical Trials Call Center
Madrid, Spain

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Isabelle Harpigny )
Study ID Numbers:	208129/033, 208129/038
Study First Received:	June 11, 2008
Last Updated:	June 13, 2008
ClinicalTrials.gov Identifier:	NCT00698061 History of Changes
Health Authority:	Spain: Ministry of Health; Belgium: Institutional Review Board

Keywords provided by GlaxoSmithKline:

Adjuvanted vaccine
Hepatitis B

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:

Virus Diseases
Hepatitis
Liver Diseases
Digestive System Diseases

Hepatitis B
Hepatitis, Viral, Human
DNA Virus Infections
Hepadnaviridae Infections

ClinicalTrials.gov processed this record on May 07, 2009