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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00435812
Recruitment Status : Completed
First Posted : February 15, 2007
Results First Posted : February 13, 2018
Last Update Posted : March 20, 2019
Information provided by (Responsible Party):
Dynavax Technologies Corporation

Brief 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®.

Condition or disease Intervention/treatment Phase
Hepatitis B Biological: HEPLISAV and/or Placebo Biological: Engerix-B Phase 3

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®.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2428 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: 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®
Study Start Date : December 2006
Actual Primary Completion Date : February 2008
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

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

Active Comparator: Engerix-B
1.0 mL Engerix-B
Biological: Engerix-B
Intramuscular (IM) injections on Week 0, Week 4, and Week 24
Other Name: Hepatitis B vaccine (recombinant)

Primary Outcome Measures :
  1. 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®)

Secondary Outcome Measures :
  1. Percentage of Participants With Local and Systemic Reactions to Injections [ Time Frame: Within 7 days post-injection for Post Injection Reactions ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   11 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00435812

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Canada, Alberta
Edmonton, Alberta, Canada
Canada, British Columbia
Surrey, British Columbia, Canada
Canada, Manitoba
Winnipeg, Manitoba, Canada
Canada, Newfoundland and Labrador
Mount Pearl, Newfoundland and Labrador, Canada
St. John's, Newfoundland and Labrador, Canada
Canada, Nova Scotia
Halifax, Nova Scotia, Canada
Canada, Ontario
Ottawa, Ontario, Canada
Sarnia, Ontario, Canada
Toronto, Ontario, Canada
Canada, Prince Edward Island
Charlottetown, Prince Edward Island, Canada
Canada, Quebec
Montréal, Quebec, Canada
Québec, Quebec, Canada
Berlin, Germany
Hamburg, Germany
Leipzig, Germany
Magdeburg, Germany
Munich, Germany
Ulm, Germany
Sponsors and Collaborators
Dynavax Technologies Corporation
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Study Director: J. Tyler Martin, Sr, MD Dynavax Technologies Corporation

Additional Information:
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Responsible Party: Dynavax Technologies Corporation Identifier: NCT00435812     History of Changes
Other Study ID Numbers: DV2-HBV-10
2006-006743-31 ( EudraCT Number )
First Posted: February 15, 2007    Key Record Dates
Results First Posted: February 13, 2018
Last Update Posted: March 20, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dynavax Technologies Corporation:
HBV vaccine
Hepatitis B vaccine
Hepatitis B
Immunostimulatory sequence (ISS)
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Immunologic Factors
Physiological Effects of Drugs