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Immunogenicity and Safety of an Adjuvanted HBV Vaccine Compared to Engerix™-B, in a Non-responder Population ≥ 15y

Primary Purpose

Hepatitis B

Status

Completed

Phase

Phase 3

Locations

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, Adjuvanted vaccine

Eligibility Criteria

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

Inclusion Criteria:

At study entry:

A male or female ≥ 15 years of age at the time of the first vaccination.
Free of obvious health problems as established by medical history and clinical examination before entering into the study.
Written informed consent obtained from the subject.
Documented non-response to previous hepatitis B vaccination within 6 months after having received a full vaccination course (i.e. ≥ 3 doses of a hepatitis B vaccine)
If the subject is female, she must be of non-childbearing potential, or, if of childbearing potential, she must be abstinent or use adequate contraceptive precautions for one month prior to enrollment and up to two months after the last vaccination.

Before booster dose at month 12:

Additional written informed consent covering the booster administration and blood samples at months 12 and 13 must be obtained from the subject.
If the subject is female, she must be of non-childbearing potential, or, if of childbearing potential, she must be abstinent or use adequate contraceptive precautions for one month prior to and up to two months after the administration of the booster dose

Exclusion Criteria:

Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) during the study period or within 30 days preceding the first dose of study vaccine.
Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of vaccine and ending 30 days after.
Known exposure to hepatitis B within 6 weeks.
History of hepatitis B infection.
Confirmed human immunodeficiency virus (HIV) infection.
A family history of congenital or hereditary immunodeficiency.
History of allergic disease/reactions likely to be exacerbated by any component of the vaccine.
Acute disease at the time of enrollment.
Hepatomegaly, right upper quadrant abdominal pain or tenderness.
Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration/ administration during the study period.
Pregnant or lactating female.

Sites / Locations

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

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

Occurrence, intensity and relationship to vaccination of unsolicited signs and symptoms

Occurrence, intensity and relationship to vaccination of serious adverse events (SAEs)

Anti-HBs antibody concentrations in all subjects

Full Information

NCT ID

NCT00698061

First Posted

June 11, 2008

Last Updated

May 25, 2017

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT00698061

Brief Title

Immunogenicity and Safety of an Adjuvanted HBV Vaccine Compared to Engerix™-B, in a Non-responder Population ≥ 15y

Official Title

A Study to Compare the Immunogenicity and Safety of GSK Biologicals Adjuvanted HBV Vaccine to Engerix™-B, in a Non-responder Population ≥ 15 Years of Age, When Administered Intramuscularly, According to a 0, 1, 2, 12 Month Schedule

Study Type

Interventional

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Completed

Study Start Date

November 1999 (undefined)

Primary Completion Date

September 2000 (Actual)

Study Completion Date

May 2001 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Subjects who had not responded to previous hepatitis B vaccination were vaccinated with either the adjuvanted HBV-MPL vaccine or Engerix™-B vaccine according to a three-dose vaccination schedule (0, 1, 2 months) and boosted at Month 12 as per their group allocation. The immunogenicity and safety of the HBV-MPL vaccine were compared with the control vaccine, Engerix™-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, Adjuvanted vaccine

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

145 (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)

HBV-MPL vaccine 208129

Intervention Description

3-dose primary vaccination and booster vaccination by intramuscular injection

Intervention Type

Biological

Intervention Name(s)

Engerix™-B

Intervention Description

3-dose primary vaccination and booster vaccination by intramuscular injection

Primary Outcome Measure Information:

Title

Anti-HBs antibody concentrations

Time Frame

Months 1, 2 and 3

Secondary Outcome Measure Information:

Title

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

Time Frame

During a 4 day follow-up period after vaccination

Title

Occurrence, intensity and relationship to vaccination of unsolicited signs and symptoms

Time Frame

During a 30 day follow-up period after vaccination

Title

Occurrence, intensity and relationship to vaccination of serious adverse events (SAEs)

Time Frame

During the study period, up to and including 6 months post-vaccination

Title

Anti-HBs antibody concentrations in all subjects

Time Frame

Months 1, 2, 3, 12 and 13

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: At study entry: A male or female ≥ 15 years of age at the time of the first vaccination. Free of obvious health problems as established by medical history and clinical examination before entering into the study. Written informed consent obtained from the subject. Documented non-response to previous hepatitis B vaccination within 6 months after having received a full vaccination course (i.e. ≥ 3 doses of a hepatitis B vaccine) If the subject is female, she must be of non-childbearing potential, or, if of childbearing potential, she must be abstinent or use adequate contraceptive precautions for one month prior to enrollment and up to two months after the last vaccination. Before booster dose at month 12: Additional written informed consent covering the booster administration and blood samples at months 12 and 13 must be obtained from the subject. If the subject is female, she must be of non-childbearing potential, or, if of childbearing potential, she must be abstinent or use adequate contraceptive precautions for one month prior to and up to two months after the administration of the booster dose Exclusion Criteria: Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) during the study period or within 30 days preceding the first dose of study vaccine. Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of vaccine and ending 30 days after. Known exposure to hepatitis B within 6 weeks. History of hepatitis B infection. Confirmed human immunodeficiency virus (HIV) infection. A family history of congenital or hereditary immunodeficiency. History of allergic disease/reactions likely to be exacerbated by any component of the vaccine. Acute disease at the time of enrollment. Hepatomegaly, right upper quadrant abdominal pain or tenderness. Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration/ administration during the study period. Pregnant or lactating female.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

12. IPD Sharing Statement

Citations:

PubMed Identifier

18845199

Citation

Verstraeten T, Descamps D, David MP, Zahaf T, Hardt K, Izurieta P, Dubin G, Breuer T. Analysis of adverse events of potential autoimmune aetiology in a large integrated safety database of AS04 adjuvanted vaccines. Vaccine. 2008 Dec 2;26(51):6630-8. doi: 10.1016/j.vaccine.2008.09.049.

Results Reference

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Immunogenicity and Safety of an Adjuvanted HBV Vaccine Compared to Engerix™-B, in a Non-responder Population ≥ 15y

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