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Evaluation of Immunogenicity, Reactogenicity and Safety of HBV-MPL Vaccine vs Engerix™-B, in Haemodialysis Patients

Primary Purpose

Hepatitis B

Status

Completed

Phase

Phase 1

Locations

Belgium

Study Type

Interventional

Intervention

HBV-MPL vaccine 208129

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 SexesDoes not accept healthy volunteers

Inclusion Criteria:

Dialysis patients
A medical examination including physical examination and medical history as well as serological screening established acceptability for enrollment into the study.
Age: from 18 years onwards
Seronegative for anti- hepatitis antibodies

Exclusion Criteria:

History of persistent hepatic, cardiac or respiratory disease
Any acute disease at the moment of entry into the study
Chronic alcohol consumption
Hepatomegaly, right upper quadrant pain or tenderness
Any treatment with coticosteroids or immunomodulating drugs
Known hypersensitivity to any component of the vaccine
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

Active Comparator

Experimental

Active Comparator

Experimental

Active Comparator

Experimental

Active Comparator

Experimental

Arm Label

Group A1

Group A2

Group B1

Group B2

Group C1

Group C2

Group D1

Group D2

Arm Description

Non-responders to vaccination after at least 7 previous injections

Vaccine-responders requiring a booster dose

Volunteers participating in the hospital's vaccination program

Unvaccinated haemodialysis patients

Outcomes

Primary Outcome Measures

Occurrence and intensity of solicited local and general symptoms

Occurrence of unsolicited adverse events

Occurrence of serious adverse events

Anti-HBs antibody concentrations

Secondary Outcome Measures

Full Information

NCT ID

NCT00699231

First Posted

June 13, 2008

Last Updated

June 16, 2008

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT00699231

Brief Title

Evaluation of Immunogenicity, Reactogenicity and Safety of HBV-MPL Vaccine vs Engerix™-B, in Haemodialysis Patients

Official Title

Study to Evaluate the Immunogenicity, Reactogenicity and Safety of GSK Biologicals' (Previously SmithKline Beecham Biologicals') MPL-Adjuvanted Recombinant Hepatitis B Vaccine Versus Engerix™-B, in Haemodialysis Patients

Study Type

Interventional

2. Study Status

Record Verification Date

June 2008

Overall Recruitment Status

Completed

Study Start Date

February 1992 (undefined)

Primary Completion Date

December 1992 (Actual)

Study Completion Date

December 1992 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

GlaxoSmithKline

4. Oversight

5. Study Description

Brief Summary

This trial is designed to evaluate the immunogenicity, reactogenicity and safety of an MPL-adjuvanted recombinant hepatitis B vaccine in comparison with those of Engerix™-B in haemodialysis patients with or without previous vaccination against hepatitis B

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 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group A1

Arm Type

Active Comparator

Arm Description

Non-responders to vaccination after at least 7 previous injections

Arm Title

Group A2

Arm Type

Experimental

Arm Description

Non-responders to vaccination after at least 7 previous injections

Arm Title

Group B1

Arm Type

Active Comparator

Arm Description

Vaccine-responders requiring a booster dose

Arm Title

Group B2

Arm Type

Experimental

Arm Description

Vaccine-responders requiring a booster dose

Arm Title

Group C1

Arm Type

Active Comparator

Arm Description

Volunteers participating in the hospital's vaccination program

Arm Title

Group C2

Arm Type

Experimental

Arm Description

Volunteers participating in the hospital's vaccination program

Arm Title

Group D1

Arm Type

Active Comparator

Arm Description

Unvaccinated haemodialysis patients

Arm Title

Group D2

Arm Type

Experimental

Arm Description

Unvaccinated haemodialysis patients

Intervention Type

Biological

Intervention Name(s)

HBV-MPL vaccine 208129

Intervention Description

IM injection

Intervention Type

Biological

Intervention Name(s)

Engerix™-B

Intervention Description

IM injection

Primary Outcome Measure Information:

Title

Occurrence and intensity of solicited local and general symptoms

Time Frame

4-day follow-up period after each vaccination

Title

Occurrence of unsolicited adverse events

Time Frame

During the course of the study

Title

Occurrence of serious adverse events

Time Frame

During the course of the study

Title

Anti-HBs antibody concentrations

Time Frame

Pre, Day 0, Day 30, Day 60, Day 90, Day 120, D180, D210 depending on group allocation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Dialysis patients A medical examination including physical examination and medical history as well as serological screening established acceptability for enrollment into the study. Age: from 18 years onwards Seronegative for anti- hepatitis antibodies Exclusion Criteria: History of persistent hepatic, cardiac or respiratory disease Any acute disease at the moment of entry into the study Chronic alcohol consumption Hepatomegaly, right upper quadrant pain or tenderness Any treatment with coticosteroids or immunomodulating drugs Known hypersensitivity to any component of the vaccine 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

Brussels

Country

Belgium

12. IPD Sharing Statement

Learn more about this trial

Evaluation of Immunogenicity, Reactogenicity and Safety of HBV-MPL Vaccine vs Engerix™-B, in Haemodialysis Patients

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