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Comparing Immunogenicity and Safety of Different Formulations of HBV-MPL Vaccine With Engerix™-B in Adults Aged 18-40 y

Primary Purpose

Hepatitis B

Status

Completed

Phase

Phase 2

Locations

Belgium

Study Type

Interventional

Intervention

HBV-MPL vaccine

Engerix™-B

About this trial

This is an interventional prevention trial for Hepatitis B focused on measuring Hepatitis B, HBV-MPL, Recombinant hepatitis B vaccine

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Age: between 18 and 40 years old.
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 titres at screening for anti-hepatitis 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 a hepatitis B vaccine.
Previous vaccination with an MPL containing vaccine.
Administration of immunoglobulins in the past 6 months 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 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Active Comparator

Arm Label

Group A

Group B

Group C

Group D

Group E

Group F

Arm Description

Outcomes

Primary Outcome Measures

Anti-HBs antibody concentrations

Secondary Outcome Measures

Anti-HBs antibody concentrations

Cell mediated immunity

Occurrence and intensity and relationship to vaccination of solicited local and general symptoms

Occurrence and intensity and relationship to vaccination of unsolicited symptoms

Incidence of SAE

Full Information

NCT ID

NCT00698555

First Posted

June 13, 2008

Last Updated

June 16, 2008

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT00698555

Brief Title

Comparing Immunogenicity and Safety of Different Formulations of HBV-MPL Vaccine With Engerix™-B in Adults Aged 18-40 y

Official Title

Study Comparing the Immunogenicity and Reactogenicity of Different Formulations of GSK Bio's HBV-MPL Vaccine Injected as a 0, 6 Months Schedule With That of Engerix™-B Injected as a 0, 1, 6 Months Schedule in Healthy Adults Aged 18-40 Years

Study Type

Interventional

2. Study Status

Record Verification Date

June 2008

Overall Recruitment Status

Completed

Study Start Date

March 1997 (undefined)

Primary Completion Date

May 1998 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

GlaxoSmithKline

4. Oversight

5. Study Description

Brief Summary

This study will evaluate the immunogenicity and safety of different formulations of the candidate HBV-MPL vaccine administered according to a 2-dose schedule and compare it to that of Engerix™-B administered according to a 3-dose schedule in order to determine the optimal dose of each component of the candidate HBV-MPL vaccine when administered at 0 and 6 months

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, HBV-MPL, Recombinant hepatitis B vaccine

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

163 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group A

Arm Type

Experimental

Arm Title

Group B

Arm Type

Experimental

Arm Title

Group C

Arm Type

Experimental

Arm Title

Group D

Arm Type

Experimental

Arm Title

Group E

Arm Type

Experimental

Arm Title

Group F

Arm Type

Active Comparator

Intervention Type

Biological

Intervention Name(s)

HBV-MPL vaccine

Intervention Description

5 different formulations, 2-dose intramuscular injection

Intervention Type

Biological

Intervention Name(s)

Engerix™-B

Intervention Description

3-dose intramuscular injection

Primary Outcome Measure Information:

Title

Anti-HBs antibody concentrations

Time Frame

Month 7

Secondary Outcome Measure Information:

Title

Anti-HBs antibody concentrations

Time Frame

Month 1, 2, 6 and 12

Title

Cell mediated immunity

Time Frame

Month 1, 2, 6, 7 and 12

Title

Occurrence and intensity and relationship to vaccination of solicited local and general symptoms

Time Frame

4-day follow-up after vaccination

Title

Occurrence and intensity and relationship to vaccination of unsolicited symptoms

Time Frame

31-day follow-up after vaccination

Title

Incidence of SAE

Time Frame

Throughout the study period

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age: between 18 and 40 years old. 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 titres at screening for anti-hepatitis 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 a hepatitis B vaccine. Previous vaccination with an MPL containing vaccine. Administration of immunoglobulins in the past 6 months 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

Gent

Country

Belgium

12. IPD Sharing Statement

Learn more about this trial

Comparing Immunogenicity and Safety of Different Formulations of HBV-MPL Vaccine With Engerix™-B in Adults Aged 18-40 y

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