Safety and Immunogenicity Study of the Hepatitis B Virus (HBV) Vaccine, HEPLISAV Compared to Engerix-B Vaccine
An Observer-Blinded, Randomized, Parallel-Group, Multi-Center Study Comparing the Safety and Immunogenicity of HEPLISAV™ to Licensed Vaccine (Engerix-B®) Among Healthy Subjects 40 to 70 Years of Age
1 other identifier
interventional
2,452
2 countries
32
Brief Summary
The purpose of the study is to evaluate the safety, immunogenicity and lot-to-lot consistency of an investigational hepatitis B virus vaccine, HEPLISAV™, in healthy adults 40 to 70 years of age
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 healthy
Started Feb 2010
Typical duration for phase_3 healthy
32 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
First Submitted
Initial submission to the registry
October 29, 2009
CompletedFirst Posted
Study publicly available on registry
November 2, 2009
CompletedStudy Start
First participant enrolled
February 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedResults Posted
Study results publicly available
January 11, 2018
CompletedMarch 20, 2019
March 1, 2019
11 months
October 29, 2009
December 8, 2017
March 18, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Subjects Who Have a Seroprotective Immune Response
Percentage of subjects who have a seroprotective immune response (anti-HBsAg antibody≥ 10 milli-international unit (mIU)/mL) 8 weeks after the last active dose of HEPLISAV™ compared to 8 weeks after the last active dose of Engerix-B®
at Week 12 and at Week 32
Secondary Outcomes (1)
Percentage of Participants With Local and Systemic Reaction to Injections
within 7 days for post-injection reactions
Study Arms (2)
HEPLISAV and/or Placebo
EXPERIMENTAL0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018)
Engerix-B(1)
ACTIVE COMPARATOR1.0 mL Engerix-B
Interventions
Intramuscular (IM) injections on Week 0 and 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:
- be 40 - 70 years of age, inclusive
- be seronegative for hepatitis B surface antigen (HBsAg), antibody against hepatitis B surface antigen (anti-HBsAg), antibody against hepatitis B core antigen (anti-HBcAg), and human immunodeficiency virus (HIV)
- be in good health in the opinion of the investigator, based upon medical history, physical examination, and laboratory evaluation
- if female of childbearing potential, agree to consistently use a highly effective method of birth control from screening visit through the treatment phase, for up to 28 days after the last injection
You may not qualify if:
- if female of childbearing potential, is pregnant, breastfeeding, or planning a pregnancy
- has a history of or is considered by the investigator to be at high risk for recent exposure to HBV or HIV; for example, current intravenous drug use or has unprotected sex with known HBV/HIV positive partner
- has a known history of autoimmune disease
- has previously received any hepatitis B vaccine (approved or investigational)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (32)
Unknown Facility
Huntsville, Alabama, United States
Unknown Facility
San Diego, California, United States
Unknown Facility
Santa Ana, California, United States
Unknown Facility
Denver, Colorado, United States
Unknown Facility
Melbourne, Florida, United States
Unknown Facility
Pinellas Park, Florida, United States
Unknown Facility
Atlanta, Georgia, United States
Unknown Facility
Chicago, Illinois, United States
Unknown Facility
Peoria, Illinois, United States
Unknown Facility
South Bend, Indiana, United States
Unknown Facility
Rockville, Maryland, United States
Unknown Facility
Brooklyn Center, Minnesota, United States
Unknown Facility
Edina, Minnesota, United States
Unknown Facility
Kansas City, Missouri, United States
Unknown Facility
St Louis, Missouri, United States
Unknown Facility
Rochester, New York, United States
Unknown Facility
Cincinnati, Ohio, United States
Unknown Facility
Erie, Pennsylvania, United States
Unknown Facility
Grove City, Pennsylvania, United States
Unknown Facility
Jefferson Hills, Pennsylvania, United States
Unknown Facility
Pittsburgh, Pennsylvania, United States
Unknown Facility
Upper Saint Clair, Pennsylvania, United States
Unknown Facility
Anderson, South Carolina, United States
Unknown Facility
Greer, South Carolina, United States
Unknown Facility
Nashville, Tennessee, United States
Unknown Facility
Dallas, Texas, United States
Unknown Facility
Katy, Texas, United States
Unknown Facility
San Antonio, Texas, United States
Unknown Facility
Norfolk, Virginia, United States
Unknown Facility
Mount Pearl, Newfoundland and Labrador, Canada
Unknown Facility
Toronto, Ontario, Canada
Unknown Facility
Montreal, Quebec, Canada
Related Publications (1)
Heyward WL, Kyle M, Blumenau J, Davis M, Reisinger K, Kabongo ML, Bennett S, Janssen RS, Namini H, Martin JT. Immunogenicity and safety of an investigational hepatitis B vaccine with a Toll-like receptor 9 agonist adjuvant (HBsAg-1018) compared to a licensed hepatitis B vaccine in healthy adults 40-70 years of age. Vaccine. 2013 Nov 4;31(46):5300-5. doi: 10.1016/j.vaccine.2013.05.068. Epub 2013 May 30.
PMID: 23727002DERIVED
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.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 29, 2009
First Posted
November 2, 2009
Study Start
February 1, 2010
Primary Completion
January 1, 2011
Study Completion
May 1, 2011
Last Updated
March 20, 2019
Results First Posted
January 11, 2018
Record last verified: 2019-03
Data Sharing
- IPD Sharing
- Will not share