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

Primary Purpose

Hepatitis B

Status

Completed

Phase

Phase 3

Locations

Belgium

Study Type

Interventional

Intervention

Recombinant MPL- adjuvanted hepatitis B vaccine

Engerix™-B

About this trial

This is an interventional prevention trial for Hepatitis B focused on measuring Hepatitis B, Engerix™-B, Recombinant Hepatitis B vaccine, Adjuvant

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

GSK Clinical Trials Call Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group A

Group B

Arm Description

Outcomes

Primary Outcome Measures

Anti-HBs antibody concentrations

Secondary Outcome Measures

Anti-HBs antibody concentrations

Occurrence and intensity of solicited local symptoms

Occurrence, intensity and relationship of solicited general symptoms

Occurrence, intensity and relationship to vaccination of unsolicited symptoms

Incidence of serious AEs

Cell mediated immunity

Full Information

NCT ID

NCT00697931

First Posted

June 12, 2008

Last Updated

June 13, 2008

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT00697931

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

June 2008

Overall Recruitment Status

Completed

Study Start Date

May 1997 (undefined)

Primary Completion Date

June 1998 (Actual)

Study Completion Date

June 1998 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

GlaxoSmithKline

4. Oversight

5. 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

Detailed Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatitis B

Keywords

Hepatitis B, Engerix™-B, Recombinant Hepatitis B vaccine, Adjuvant

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

116 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group A

Arm Type

Experimental

Arm Title

Group B

Arm Type

Active Comparator

Intervention Type

Biological

Intervention Name(s)

Recombinant MPL- adjuvanted hepatitis B vaccine

Intervention Description

Intramuscular injection, 3 doses

Intervention Type

Biological

Intervention Name(s)

Engerix™-B

Intervention Description

Intramuscular injection, 3 doses

Primary Outcome Measure Information:

Title

Anti-HBs antibody concentrations

Time Frame

At month 7

Secondary Outcome Measure Information:

Title

Anti-HBs antibody concentrations

Time Frame

At months 2, 6, 7 and 12

Title

Occurrence and intensity of solicited local symptoms

Time Frame

4-day follow-up after vaccination

Title

Occurrence, intensity and relationship of solicited general symptoms

Time Frame

4-day follow-up after vaccination

Title

Occurrence, intensity and relationship to vaccination of unsolicited symptoms

Time Frame

Within 30 days after vaccination

Title

Incidence of serious AEs

Time Frame

Throughout the entire study up to and including 30 days after the last vaccination

Title

Cell mediated immunity

Time Frame

At months 0, 2, 6, 7, 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Trials

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

Facility Information:

Facility Name

GSK Clinical Trials Call Center

City

Leuven

Country

Belgium

12. IPD Sharing Statement

Learn more about this trial

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

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