Safety and Efficacy of HEPLISAV™ Hepatitis B Virus Vaccine Compared With Engerix-B® Vaccine

March 18, 2019 updated by: Dynavax Technologies Corporation

A Phase III Safety and Efficacy Study to Compare Immune Responses Following Injection With Either Two Doses of HEPLISAV™ or Three Doses of Engerix-B®

The purpose of this study is to find out if a new investigational hepatitis B virus vaccine, HEPLISAV™, is safe and effective compared with Engerix-B® vaccine in subjects 11-55 years old. The primary hypothesis is that the seroprotective immune response of HEPLISAV™ is at least as good as that of Engerix-B®.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study will evaluate the safety and efficacy of two injections of HEPLISAV™, compared with three injections of a commercially available hepatitis B virus (HBV) vaccine, Engerix-B®, in subjects 11 to 55 years old. About 2,400 subjects will be included in the study. Once subjects are consented, screened, and randomized to treatment, all subjects will receive a total of three injections over a 24-week period, with a follow-up visit at 28 weeks. Subjects randomized to Engerix-B® will receive 3 injections of active vaccine, while subjects randomized to HEPLISAV™ will receive 2 injections of active vaccine plus 1 injection of placebo. Safety and tolerability will be evaluated by occurrence of adverse events, periodic laboratory tests, vital signs, and local/systemic reactogenicity.

Comparison: Subjects will receive treatment with either HEPLISAV™ or the comparator vaccine, Engerix-B®.

Study Type

Interventional

Enrollment (Actual)

2428

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada
    • British Columbia
      • Surrey, British Columbia, Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada
    • Newfoundland and Labrador
      • Mount Pearl, Newfoundland and Labrador, Canada
      • St. John's, Newfoundland and Labrador, Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
    • Ontario
      • Ottawa, Ontario, Canada
      • Sarnia, Ontario, Canada
      • Toronto, Ontario, Canada
    • Prince Edward Island
      • Charlottetown, Prince Edward Island, Canada
    • Quebec
      • Montréal, Quebec, Canada
      • Québec, Quebec, Canada
  • Germany
      • Berlin, Germany
      • Hamburg, Germany
      • Leipzig, Germany
      • Magdeburg, Germany
      • Munich, Germany
      • Ulm, Germany

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 55 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Willing and able to give written informed consent
  • Is serum negative for HBV antibodies

Exclusion Criteria:

  • Women who are pregnant or breastfeeding
  • Any previous HBV infection
  • Previous vaccination with any HBV vaccine (1 or more doses)
  • Any autoimmune disease
  • Received any blood products or antibodies within 3 months prior to study entry
  • Ever received an injection with DNA plasmids or oligonucleotides
  • Received any vaccines within 4 weeks prior to study entry
  • Received any other investigational medicinal agent within 4 weeks prior to study entry

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: HEPLISAV and/or Placebo
0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018)
Biological: HEPLISAV and/or Placebo
Intramuscular (IM) injections on Week 0, Week 4; placebo (saline) injection at Week 24
Other Names:
  • Hepatitis B vaccine (recombinant), adjuvanted
  • HEPLISAV
ACTIVE_COMPARATOR: Engerix-B
1.0 mL Engerix-B
Biological: Engerix-B
Intramuscular (IM) injections on Week 0, Week 4, and Week 24
Other Names:
  • Hepatitis B vaccine (recombinant)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Subjects With Seroprotective Immune Response
Time Frame: Week 12 for HEPLISAV and Week 28 for Engerix-B
Percentage of subjects who have a seroprotective immune response (anti-HBsAg ≥ 10 milli-international unit (mIU)/mL) after the final active injection in each treatment group (Week 12 for HEPLISAV™ and Week 28 for Engerix-B®)
Week 12 for HEPLISAV and Week 28 for Engerix-B

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants With Local and Systemic Reactions to Injections
Time Frame: Within 7 days post-injection for Post Injection Reactions
Within 7 days post-injection for Post Injection Reactions

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dynavax Technologies Corporation

Investigators

  • Study Director: J. Tyler Martin, Sr, MD, Dynavax Technologies Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (ACTUAL)

February 1, 2008

Study Completion (ACTUAL)

March 1, 2008

Study Registration Dates

First Submitted

February 13, 2007

First Submitted That Met QC Criteria

February 14, 2007

First Posted (ESTIMATE)

February 15, 2007

Study Record Updates

Last Update Posted (ACTUAL)

March 20, 2019

Last Update Submitted That Met QC Criteria

March 18, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DV2-HBV-10
  • 2006-006743-31 (EUDRACT_NUMBER)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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