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

Last updated: March 18, 2019
Sponsor: Dynavax Technologies Corporation
Overall Status: Completed

Phase

3

Condition

Hepatitis

Hepatitis B

Liver Disorders

Treatment

N/A

Clinical Study ID

NCT00435812
DV2-HBV-10
2006-006743-31
  • Ages 11-55
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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®.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Willing and able to give written informed consent

  • Is serum negative for HBV antibodies

Exclusion

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 Design

Total Participants: 2428
Study Start date:
December 01, 2006
Estimated Completion Date:
March 31, 2008

Study 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®.

Connect with a study center

  • Edmonton, Alberta
    Canada

    Site Not Available

  • Surrey, British Columbia
    Canada

    Site Not Available

  • Winnipeg, Manitoba
    Canada

    Site Not Available

  • Mount Pearl, Newfoundland and Labrador
    Canada

    Site Not Available

  • St. John's, Newfoundland and Labrador
    Canada

    Site Not Available

  • Halifax, Nova Scotia
    Canada

    Site Not Available

  • Ottawa, Ontario
    Canada

    Site Not Available

  • Sarnia, Ontario
    Canada

    Site Not Available

  • Toronto, Ontario
    Canada

    Site Not Available

  • Charlottetown, Prince Edward Island
    Canada

    Site Not Available

  • Montréal, Quebec
    Canada

    Site Not Available

  • empty

    Pierrefonds, Quebec
    Canada

    Site Not Available

  • Centre Hospitalier Universitaire de Québec

    Québec, Quebec G1E 7G9
    Canada

    Site Not Available

  • Québec, Quebec
    Canada

    Site Not Available

  • Berlin,
    Germany

    Site Not Available

  • Hamburg,
    Germany

    Site Not Available

  • Leipzig,
    Germany

    Site Not Available

  • Magdeburg,
    Germany

    Site Not Available

  • Munich,
    Germany

    Site Not Available

  • Ulm,
    Germany

    Site Not Available

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