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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dynavax Technologies Corporation
ClinicalTrials.gov Identifier:
NCT00435812
First received: February 13, 2007
Last updated: July 16, 2014
Last verified: July 2014
  Purpose

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 Intervention Phase
Hepatitis B
Biological: 1018 ISS with HBsAg
Biological: Engerix-B
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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®

Resource links provided by NLM:


Further study details as provided by Dynavax Technologies Corporation:

Primary Outcome Measures:
  • Proportion 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®) [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rates of adverse events and local and systemic reactions to injections [ Time Frame: 28 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 2428
Study Start Date: December 2006
Study Completion Date: March 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1018 ISS with HBsAg
0.5 mL 1018 ISS (immunostimulatory sequence) with HBsAg (hepatitis B surface antigen)
Biological: 1018 ISS with HBsAg
Intramuscular (IM) injections on Week 0 and Week 4; placebo (saline) injection at Week 24
Other Names:
  • HEPLISAV
  • 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)

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 1,740 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®.

  Eligibility

Ages Eligible for Study:   11 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00435812

Locations
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
Pierrefonds, Quebec, Canada
Québec, Quebec, Canada
Germany
Berlin, Germany
Hamburg, Germany
Leipzig, Germany
Magdeburg, Germany
Munich, Germany
Ulm, Germany
Sponsors and Collaborators
Dynavax Technologies Corporation
Investigators
Study Director: J. Tyler Martin, Sr, MD Dynavax Technologies Corporation
  More Information

Additional Information:
No publications provided

Responsible Party: Dynavax Technologies Corporation
ClinicalTrials.gov Identifier: NCT00435812     History of Changes
Other Study ID Numbers: DV2-HBV-10, 2006-006743-31
Study First Received: February 13, 2007
Last Updated: July 16, 2014
Health Authority: Germany: Paul-Ehrlich-Institut
Canada: Health Canada
United States: Food and Drug Administration

Keywords provided by Dynavax Technologies Corporation:
HBV vaccine
Hepatitis B vaccine
Hepatitis B
Hepatitis
HBV
Immunostimulatory sequence (ISS)

Additional relevant MeSH terms:
Hepatitis
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

ClinicalTrials.gov processed this record on September 30, 2014