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Immunogenicity & Reactogenicity of HBV-MPL Vaccine and Engerix™-B in Healthy Adults Following 2 Different Schedules

Primary Purpose

Hepatitis B

Status

Completed

Phase

Phase 2

Locations

Belgium

Study Type

Interventional

Intervention

Engerix™-B

HBV-MPL vaccine

About this trial

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

Eligibility Criteria

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

Inclusion Criteria:

Between 18 and 40 years old.
Written informed consent will have been obtained from the subjects.
Good physical condition as established by physical examination and history taking at the time of entry.
Female participants will avoid becoming pregnant during the study period and they will have been on a contraceptive program for at least 2 months before entry.

Exclusion Criteria:

Positive titres for anti hepatitis B antibodies.
Any vaccination against hepatitis B in the past.
Elevated serum liver enzymes.
History of significant and persisting hematologic, hepatic, renal, cardiac or respiratory disease.
Axillary temperature > 37°C at the time of injection.
Any acute disease at the moment of entry.
Chronic alcohol consumption.
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.
Administration of any other vaccine(s) or any immunoglobulin during the study period.
Simultaneous participation in any other clinical trial.

Sites / Locations

GSK Clinical Trials Call Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Arm Label

Group A

Group B

Group C

Group D

Group E

Group F

Group G

Group H

Arm Description

Subjects will receive HBV-MPL vaccine in the primary schedule 0, 2 months and will receive a booster dose of HBV-MPL vaccine at 70 months

Subjects will receive HBV-MPL vaccine in the primary schedule 0, 2 months and will receive a booster dose of Engerix™-B vaccine at 70 months

Subjects will receive Engerix™-B vaccine in the primary schedule 0, 2 months and will receive a booster dose of HBV-MPL vaccine at 70 months

Subjects will receive Engerix™-B vaccine in the primary schedule 0, 2 months and will receive a booster dose of Engerix™-B vaccine at 70 months

Subjects will receive HBV-MPL vaccine in the primary schedule 0, 6 months and will receive a booster dose of HBV-MPL vaccine at 70 months

Subjects will receive HBV-MPL vaccine in the primary schedule 0, 6 months and will receive a booster dose of Engerix™-B vaccine at 70 months

Subjects will receive Engerix™-B vaccine in the primary schedule 0, 6 months and will receive a booster dose of HBV-MPL vaccine at 70 months

Subjects will receive Engerix™-B vaccine in the primary schedule 0, 6 months and will receive a booster dose of Engerix™-B vaccine at 70 months

Outcomes

Primary Outcome Measures

Anti-hepatitis B surface antigen (HBs) antibody concentrations

Secondary Outcome Measures

Anti-HBs antibody concentrations

Serious adverse experiences (SAE).

Occurrence and intensity of solicited local symptoms

Occurrence, intensity and relationship of solicited general symptoms

Incidence of unsolicited symptoms

Full Information

NCT ID

NCT00697229

First Posted

June 11, 2008

Last Updated

June 11, 2008

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT00697229

Brief Title

Immunogenicity & Reactogenicity of HBV-MPL Vaccine and Engerix™-B in Healthy Adults Following 2 Different Schedules

Official Title

Study to Evaluate the Immunogenicity and Reactogenicity of GSK Biologicals' MPL-Adjuvanted Recombinant Hepatitis B Vaccine in Comparison With Those of Engerix™-B in Healthy Adult Volunteers Following 2 Different Schedules

Study Type

Interventional

2. Study Status

Record Verification Date

June 2008

Overall Recruitment Status

Completed

Study Start Date

September 1992 (undefined)

Primary Completion Date

May 1996 (Actual)

Study Completion Date

December 1998 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

GlaxoSmithKline

4. Oversight

5. Study Description

Brief Summary

The purpose of this study is to evaluate the safety, immunogenicity and reactogenicity of MPL-adjuvanted recombinant hepatitis B vaccine in comparison with those of Engerix™-B in healthy adult volunteers following two different schedules: 0, 2 months and 0, 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, Engerix™-B, Recombinant hepatitis B vaccine

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

99 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group A

Arm Type

Experimental

Arm Description

Subjects will receive HBV-MPL vaccine in the primary schedule 0, 2 months and will receive a booster dose of HBV-MPL vaccine at 70 months

Arm Title

Group B

Arm Type

Experimental

Arm Description

Subjects will receive HBV-MPL vaccine in the primary schedule 0, 2 months and will receive a booster dose of Engerix™-B vaccine at 70 months

Arm Title

Group C

Arm Type

Experimental

Arm Description

Subjects will receive Engerix™-B vaccine in the primary schedule 0, 2 months and will receive a booster dose of HBV-MPL vaccine at 70 months

Arm Title

Group D

Arm Type

Experimental

Arm Description

Subjects will receive Engerix™-B vaccine in the primary schedule 0, 2 months and will receive a booster dose of Engerix™-B vaccine at 70 months

Arm Title

Group E

Arm Type

Experimental

Arm Description

Subjects will receive HBV-MPL vaccine in the primary schedule 0, 6 months and will receive a booster dose of HBV-MPL vaccine at 70 months

Arm Title

Group F

Arm Type

Experimental

Arm Description

Subjects will receive HBV-MPL vaccine in the primary schedule 0, 6 months and will receive a booster dose of Engerix™-B vaccine at 70 months

Arm Title

Group G

Arm Type

Experimental

Arm Description

Subjects will receive Engerix™-B vaccine in the primary schedule 0, 6 months and will receive a booster dose of HBV-MPL vaccine at 70 months

Arm Title

Group H

Arm Type

Experimental

Arm Description

Subjects will receive Engerix™-B vaccine in the primary schedule 0, 6 months and will receive a booster dose of Engerix™-B vaccine at 70 months

Intervention Type

Biological

Intervention Name(s)

Engerix™-B

Intervention Description

Intramuscular injection, 1 or 3 doses

Intervention Type

Biological

Intervention Name(s)

HBV-MPL vaccine

Intervention Description

Intramuscular injection, 1 or 3 doses

Primary Outcome Measure Information:

Title

Anti-hepatitis B surface antigen (HBs) antibody concentrations

Time Frame

One month after the full primary vaccination course and one month after the booster vaccination at 70 months

Secondary Outcome Measure Information:

Title

Anti-HBs antibody concentrations

Time Frame

Months 1, 2, 3, 6, 12, 13, 42

Title

Serious adverse experiences (SAE).

Time Frame

Throughout the study period

Title

Occurrence and intensity of solicited local symptoms

Time Frame

8-day follow-up after vaccination

Title

Occurrence, intensity and relationship of solicited general symptoms

Time Frame

8-day follow-up after vaccination

Title

Incidence of unsolicited symptoms

Time Frame

During the 30-day follow-up after vaccination

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: Between 18 and 40 years old. Written informed consent will have been obtained from the subjects. Good physical condition as established by physical examination and history taking at the time of entry. Female participants will avoid becoming pregnant during the study period and they will have been on a contraceptive program for at least 2 months before entry. Exclusion Criteria: Positive titres for anti hepatitis B antibodies. Any vaccination against hepatitis B in the past. Elevated serum liver enzymes. History of significant and persisting hematologic, hepatic, renal, cardiac or respiratory disease. Axillary temperature > 37°C at the time of injection. Any acute disease at the moment of entry. Chronic alcohol consumption. 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. Administration of any other vaccine(s) or any immunoglobulin during the study period. Simultaneous participation in any other clinical trial.

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

Wilrijk

Country

Belgium

12. IPD Sharing Statement

Learn more about this trial

Immunogenicity & Reactogenicity of HBV-MPL Vaccine and Engerix™-B in Healthy Adults Following 2 Different Schedules

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