Safety and Efficacy of HEPLISAV™ Hepatitis B Virus Vaccine Compared With Engerix-B® Vaccine
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®
2 other identifiers
interventional
2,428
2 countries
18
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®.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2006
Shorter than P25 for phase_3
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2006
CompletedFirst Submitted
Initial submission to the registry
February 13, 2007
CompletedFirst Posted
Study publicly available on registry
February 15, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2008
CompletedResults Posted
Study results publicly available
February 13, 2018
CompletedMarch 20, 2019
March 1, 2019
1.2 years
February 13, 2007
December 8, 2017
March 18, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Subjects With Seroprotective Immune Response
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 Outcomes (1)
Percentage of Participants With Local and Systemic Reactions to Injections
Within 7 days post-injection for Post Injection Reactions
Study Arms (2)
HEPLISAV and/or Placebo
EXPERIMENTAL0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018)
Engerix-B
ACTIVE COMPARATOR1.0 mL Engerix-B
Interventions
Intramuscular (IM) injections on Week 0, Week 4; placebo (saline) injection at Week 24
Intramuscular (IM) injections on Week 0, Week 4, and Week 24
Eligibility Criteria
You may qualify if:
- Willing and able to give written informed consent
- Is serum negative for HBV antibodies
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Unknown Facility
Edmonton, Alberta, Canada
Unknown Facility
Surrey, British Columbia, Canada
Unknown Facility
Winnipeg, Manitoba, Canada
Unknown Facility
Mount Pearl, Newfoundland and Labrador, Canada
Unknown Facility
St. John's, Newfoundland and Labrador, Canada
Unknown Facility
Halifax, Nova Scotia, Canada
Unknown Facility
Ottawa, Ontario, Canada
Unknown Facility
Sarnia, Ontario, Canada
Unknown Facility
Toronto, Ontario, Canada
Unknown Facility
Charlottetown, Prince Edward Island, Canada
Unknown Facility
Montreal, Quebec, Canada
Unknown Facility
Québec, Quebec, Canada
Unknown Facility
Berlin, Germany
Unknown Facility
Hamburg, Germany
Unknown Facility
Leipzig, Germany
Unknown Facility
Magdeburg, Germany
Unknown Facility
Munich, Germany
Unknown Facility
Ulm, Germany
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Robert Janssen MD \ VP & Chief Medical Officer
- Organization
- Dynavax Technologies, Inc.
Study Officials
- STUDY DIRECTOR
J. Tyler Martin, Sr, MD
Dynavax Technologies Corporation
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 13, 2007
First Posted
February 15, 2007
Study Start
December 1, 2006
Primary Completion
February 1, 2008
Study Completion
March 1, 2008
Last Updated
March 20, 2019
Results First Posted
February 13, 2018
Record last verified: 2019-03
Data Sharing
- IPD Sharing
- Will not share