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Immunogenicity and Safety of a Novel Adjuvanted HBV Vaccine in Pre-liver Transplant Patients 18 Years of Age

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 hepatitis B vaccine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

A male or female ≥ 18 years of age at the time of the first vaccination.
Written informed consent obtained from the subject.
Seronegative for anti-HBs-antibodies, anti-HBc-antibodies & HBsAg.
If the subject is female, she must be of non-childbearing potential or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series.
Documented case of liver failure, such that the patient will require an eventual liver transplant

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.
Previous vaccination against hepatitis B (whether or not a non-responder to vaccination).
Previous vaccination with an adjuvant system containing MPL®.
History of hepatitis B infection.
Known exposure to hepatitis B virus within 6 weeks.
Previously confirmed human immunodeficiency virus (HIV) infection.
A family history of congenital or hereditary immunodeficiency.
Immunosuppression caused by the administration of parenteral steroids or chemotherapy.
Suspected or confirmed multiple sclerosis in the subject (applicable to Centres 011, 012, 013 and 014/ France only).
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
Acute, intercurrent disease at the time of enrollment.
Oral/axillary temperature of ≥ 37.5°C (≥ 99.5°F).
Administration of immunoglobulins and/or any blood products within one month 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 symptoms

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

Anti-HBs antibody concentrations

Full Information

NCT ID

NCT00697554

First Posted

June 12, 2008

Last Updated

September 8, 2016

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT00697554

Brief Title

Immunogenicity and Safety of a Novel Adjuvanted HBV Vaccine in Pre-liver Transplant Patients 18 Years of Age

Official Title

Study to Compare the Immunogenicity and Safety of GSK Biologicals' Novel Adjuvanted HBV Vaccine (0, 21-day Schedule) to a Double Dose of Engerix™ -B (0, 7, 21-day Schedule), in Pre-liver Transplant Patients ≥ 18 y, Boosted at Month 6-12

Study Type

Interventional

2. Study Status

Record Verification Date

September 2016

Overall Recruitment Status

Completed

Study Start Date

January 2000 (undefined)

Primary Completion Date

May 2002 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to enroll pre-liver transplant patients who will be vaccinated with either the novel adjuvanted HBV vaccine or double doses of Engerix™-B. The immunogenicity and safety of the novel adjuvanted vaccine will be compared to Engerix™-B as the control vaccine

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 hepatitis B vaccine

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

93 (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

2-dose primary vaccination followed by 1 booster vaccination by intramuscular injection

Intervention Type

Biological

Intervention Name(s)

Engerix™-B

Other Intervention Name(s)

HBV-MPL vaccine 208129

Intervention Description

3-dose primary vaccination followed by 1 booster vaccination by intramuscular injection of double doses

Primary Outcome Measure Information:

Title

Anti-HBs antibody concentrations

Time Frame

At Day 28

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 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

Title

Anti-HBs antibody concentrations

Time Frame

At d21, d28, d56, M6-12, 1M after booster dose

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: A male or female ≥ 18 years of age at the time of the first vaccination. Written informed consent obtained from the subject. Seronegative for anti-HBs-antibodies, anti-HBc-antibodies & HBsAg. If the subject is female, she must be of non-childbearing potential or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series. Documented case of liver failure, such that the patient will require an eventual liver transplant 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. Previous vaccination against hepatitis B (whether or not a non-responder to vaccination). Previous vaccination with an adjuvant system containing MPL®. History of hepatitis B infection. Known exposure to hepatitis B virus within 6 weeks. Previously confirmed human immunodeficiency virus (HIV) infection. A family history of congenital or hereditary immunodeficiency. Immunosuppression caused by the administration of parenteral steroids or chemotherapy. Suspected or confirmed multiple sclerosis in the subject (applicable to Centres 011, 012, 013 and 014/ France only). History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. Acute, intercurrent disease at the time of enrollment. Oral/axillary temperature of ≥ 37.5°C (≥ 99.5°F). Administration of immunoglobulins and/or any blood products within one month 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

Plan to Share IPD

Yes

IPD Sharing Plan Description

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Citations:

PubMed Identifier

16964595

Citation

Nevens F, Zuckerman JN, Burroughs AK, Jung MC, Bayas JM, Kallinowski B, Rivas EF, Duvoux C, Neuhaus P, Saliba F, Buti M, Zarski JP, Pons F, Vanlemmens C, Hamtiaux V, Stoffel M. Immunogenicity and safety of an experimental adjuvanted hepatitis B candidate vaccine in liver transplant patients. Liver Transpl. 2006 Oct;12(10):1489-95. doi: 10.1002/lt.20836.

Results Reference

background

Citation

Nevens F et al. Immunogenicity and safety of a novel adjuvanted hepatitis B candidate vaccine in liver transplant patients. Abstract presented at the 39th Annual Meeting of the European Association for the Study of Liver (EASL), Berlin, Germany, 14-18 April 2004.

Results Reference

background

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

background

Links:

URL

https://www.clinicalstudydatarequest.com

Description

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Available IPD and Supporting Information:

Available IPD/Information Type

Clinical Study Report

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

208129/036

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Informed Consent Form

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

208129/036

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Study Protocol

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

208129/036

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Individual Participant Data Set

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

208129/036

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Dataset Specification

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

208129/036

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

Immunogenicity and Safety of a Novel Adjuvanted HBV Vaccine in Pre-liver Transplant Patients 18 Years of Age

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