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

NCT ID: NCT00435812

Last Updated: 2019-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 2428 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-12-31
• Study Completion Date: 2008-03-31

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®.

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®.

Conditions

Hepatitis B

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

HEPLISAV and/or Placebo

0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018)

Group Type: EXPERIMENTAL

HEPLISAV and/or Placebo

Intervention Type: BIOLOGICAL

Intramuscular (IM) injections on Week 0, Week 4; placebo (saline) injection at Week 24

Engerix-B

1.0 mL Engerix-B

Group Type: ACTIVE_COMPARATOR

Engerix-B

Intervention Type: BIOLOGICAL

Intramuscular (IM) injections on Week 0, Week 4, and Week 24

Interventions

HEPLISAV and/or Placebo

Intramuscular (IM) injections on Week 0, Week 4; placebo (saline) injection at Week 24

Intervention Type: BIOLOGICAL

Engerix-B

Intramuscular (IM) injections on Week 0, Week 4, and Week 24

Intervention Type: BIOLOGICAL

Other Intervention Names

HEPLISAV; Hepatitis B vaccine (recombinant), adjuvanted; Hepatitis B vaccine (recombinant)

Eligibility 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

• Minimum Eligible Age: 11 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Dynavax Technologies Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

J. Tyler Martin, Sr, MD

Role: STUDY_DIRECTOR

Dynavax Technologies Corporation

Locations

Edmonton, Alberta, Canada

Surrey, British Columbia, Canada

Winnipeg, Manitoba, Canada

Mount Pearl, Newfoundland and Labrador, Canada

St. John's, Newfoundland and Labrador, Canada

Halifax, Nova Scotia, Canada

Ottawa, Ontario, Canada

Sarnia, Ontario, Canada

Toronto, Ontario, Canada

Charlottetown, Prince Edward Island, Canada

Montreal, Quebec, Canada

Québec, Quebec, Canada

Berlin, , Germany

Hamburg, , Germany

Leipzig, , Germany

Magdeburg, , Germany

Munich, , Germany

Ulm, , Germany

Countries

Canada; Germany

Related Links

http://www.dynavax.com

Dynavax Webpage

Other Identifiers

2006-006743-31

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

DV2-HBV-10

Identifier Type: -

Identifier Source: org_study_id