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CompletedNCT00697554Updated Sep 9, 2016

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

A Phase 3 interventional study of HBV-MPL vaccine 208129 and Engerix™-B in Hepatitis B, sponsored by GlaxoSmithKline. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-09-09.

Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
93
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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

Read the detailed description

At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham

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Conditions studied

  • Hepatitis B

Keywords

  • Hepatitis B
  • Adjuvanted hepatitis B vaccine
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In context

Hepatitis B

1,656 studies on the registry are indexed under Hepatitis B; 196 are open to participants now.

This study's enrollment of 93 is below the median of 120 across 1,187 interventional studies indexed under Hepatitis B.

Browse Hepatitis B studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
93 participants (actual)

Study arms

  • Experimental
    Group A

    Biological: HBV-MPL vaccine 208129

  • Active comparator
    Group B

    Biological: Engerix™-B

Interventions

  • BiologicalHBV-MPL vaccine 208129

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

  • BiologicalEngerix™-B

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

    Also known as: HBV-MPL vaccine 208129

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What researchers measure

Primary outcomes

  1. Anti-HBs antibody concentrations

    Time frame: At Day 28

Secondary outcomes

  1. 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

  2. Occurrence, intensity and relationship to vaccination of unsolicited symptoms

    Time frame: During a 30 day follow-up period after vaccination

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

    Time frame: During the study period

  4. Anti-HBs antibody concentrations

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

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 16964595 ↗
  • 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.
  • 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. PubMed 18845199 ↗

Individual participant data

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

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 9, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00697554
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Jun 16, 2008
Start date
Jan 2000
Primary completion
May 2002
Last update
Sep 9, 2016

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.

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