Immunogenicity and Reactogenicity of MPL Adjuvanted Recombinant Hepatitis B- Vaccine and Engerix™-B in Adult Non-Responders

Sponsor

GlaxoSmithKline (Industry)

Overall Status

Completed

CT.gov ID

NCT00697931

Collaborator

(none)

116

Enrollment

Location

Arms

Duration (Months)

8.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to compare the immunogenicity and reactogenicity of the adjuvanted recombinant hepatitis B vaccine with that of Engerix™-B when both are injected according to a three dose schedule (0, 1, 6 months) in an adult non-responder population

Condition or Disease	Intervention/Treatment	Phase
Hepatitis B	Biological: Recombinant MPL- adjuvanted hepatitis B vaccine Biological: Engerix™-B	Phase 3

Detailed Description

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

Study Design

Study Type:

Interventional

Actual Enrollment :

116 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Prevention

Official Title:

Study to Compare the Immunogenicity and Reactogenicity of GSK Biologicals; (Previously SmithKline Beecham Biologicals') MPL-Adjuvanted Recombinant Hepatitis B Vaccine With That of Engerix™-B in an Adult Non-Responder Population

Study Start Date :

May 1, 1997

Actual Primary Completion Date :

Jun 1, 1998

Actual Study Completion Date :

Jun 1, 1998

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group A	Biological: Recombinant MPL- adjuvanted hepatitis B vaccine Intramuscular injection, 3 doses
Active Comparator: Group B	Biological: Engerix™-B Intramuscular injection, 3 doses

Arm

Intervention/Treatment

Experimental: Group A

Biological: Recombinant MPL- adjuvanted hepatitis B vaccine

Intramuscular injection, 3 doses

Active Comparator: Group B

Biological: Engerix™-B

Intramuscular injection, 3 doses

Outcome Measures

Primary Outcome Measures

Anti-HBs antibody concentrations [At month 7]

Secondary Outcome Measures

Anti-HBs antibody concentrations [At months 2, 6, 7 and 12]
Occurrence and intensity of solicited local symptoms [4-day follow-up after vaccination]
Occurrence, intensity and relationship of solicited general symptoms [4-day follow-up after vaccination]
Occurrence, intensity and relationship to vaccination of unsolicited symptoms [Within 30 days after vaccination]
Incidence of serious AEs [Throughout the entire study up to and including 30 days after the last vaccination]
Cell mediated immunity [At months 0, 2, 6, 7, 12]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Age: older than 18 years of age.
Documented non-responders 2 to 5 months after having received 4 doses of a hepatitis B vaccine
Good physical condition as established by clinical examination and history taking at the time of entry.
Female participants who are at risk to become pregnant will be on a contraceptive programme if necessary during the study period.
Written informed consent obtained from the subjects

Exclusion Criteria:

Positive at screening for anti-HBV antibodies
Elevated serum liver enzymes.
History of significant and persisting hematologic, hepatic, renal, cardiac or respiratory disease.
Any acute disease at the moment of entry.
Chronic alcohol consumption.
Hepatomegaly, right upper quadrant abdominal pain or tenderness.
Any chronic drug treatment, including any treatment with immunosuppressive drugs, which in the investigator's opinion, precludes inclusion into the study.
History of allergic disease likely to be stimulated by any component of the vaccine.
Simultaneous participation in any other clinical trial.
Previous vaccination with an MPL containing vaccine.
Administration of immunoglobulins 6 months before and during the whole study period
Vaccination one month before and one month after each dose of the study vaccine