Safety and Immunogenicity Study of the Hepatitis B Virus (HBV) Vaccine, HEPLISAV Compared to Engerix-B Vaccine
Primary Purpose
Healthy
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
HEPLISAV and/or Placebo
Engerix-B
Sponsored by
About this trial
This is an interventional prevention trial for Healthy focused on measuring HBV vaccine, Hepatitis B vaccine, Hepatitis B, Hepatitis, HBV, Prevention & Control, Healthy, Healthy volunteers
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
HEPLISAV and/or Placebo
Engerix-B(1)
Arm Description
0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018)
1.0 mL Engerix-B
Outcomes
Primary Outcome Measures
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®
Secondary Outcome Measures
Percentage of Participants With Local and Systemic Reaction to Injections
Full Information
NCT ID
NCT01005407
First Posted
October 29, 2009
Last Updated
March 18, 2019
Sponsor
Dynavax Technologies Corporation
1. Study Identification
Unique Protocol Identification Number
NCT01005407
Brief Title
Safety and Immunogenicity Study of the Hepatitis B Virus (HBV) Vaccine, HEPLISAV Compared to Engerix-B Vaccine
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
May 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dynavax Technologies Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
Detailed Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy
Keywords
HBV vaccine, Hepatitis B vaccine, Hepatitis B, Hepatitis, HBV, Prevention & Control, Healthy, Healthy volunteers
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2452 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HEPLISAV and/or Placebo
Arm Type
Experimental
Arm Description
0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018)
Arm Title
Engerix-B(1)
Arm Type
Active Comparator
Arm Description
1.0 mL Engerix-B
Intervention Type
Biological
Intervention Name(s)
HEPLISAV and/or Placebo
Other Intervention Name(s)
Hepatitis B vaccine (recombinant), adjuvanted
Intervention Description
Intramuscular (IM) injections on Week 0 and Week 4; placebo (saline) injection at Week 24
Intervention Type
Biological
Intervention Name(s)
Engerix-B
Other Intervention Name(s)
Hepatitis B vaccine (recombinant)
Intervention Description
Intramuscular (IM) injections on Week 0, Week 4 and Week 24
Primary Outcome Measure Information:
Title
Percentage of Subjects Who Have a Seroprotective Immune Response
Description
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®
Time Frame
at Week 12 and at Week 32
Secondary Outcome Measure Information:
Title
Percentage of Participants With Local and Systemic Reaction to Injections
Time Frame
within 7 days for post-injection reactions
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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)
Facility Information:
City
Huntsville
State/Province
Alabama
Country
United States
City
San Diego
State/Province
California
Country
United States
City
Santa Ana
State/Province
California
Country
United States
City
Denver
State/Province
Colorado
Country
United States
City
Melbourne
State/Province
Florida
Country
United States
City
Pinellas Park
State/Province
Florida
Country
United States
City
Atlanta
State/Province
Georgia
Country
United States
City
Chicago
State/Province
Illinois
Country
United States
City
Peoria
State/Province
Illinois
Country
United States
City
South Bend
State/Province
Indiana
Country
United States
City
Rockville
State/Province
Maryland
Country
United States
City
Brooklyn Center
State/Province
Minnesota
Country
United States
City
Edina
State/Province
Minnesota
Country
United States
City
Kansas City
State/Province
Missouri
Country
United States
City
Saint Louis
State/Province
Missouri
Country
United States
City
Rochester
State/Province
New York
Country
United States
City
Cincinnati
State/Province
Ohio
Country
United States
City
Erie
State/Province
Pennsylvania
Country
United States
City
Grove City
State/Province
Pennsylvania
Country
United States
City
Jefferson Hills
State/Province
Pennsylvania
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
City
Upper Saint Clair
State/Province
Pennsylvania
Country
United States
City
Anderson
State/Province
South Carolina
Country
United States
City
Greer
State/Province
South Carolina
Country
United States
City
Nashville
State/Province
Tennessee
Country
United States
City
Dallas
State/Province
Texas
Country
United States
City
Katy
State/Province
Texas
Country
United States
City
San Antonio
State/Province
Texas
Country
United States
City
Norfolk
State/Province
Virginia
Country
United States
City
Mount Pearl
State/Province
Newfoundland and Labrador
Country
Canada
City
Toronto
State/Province
Ontario
Country
Canada
City
Montreal
State/Province
Quebec
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
23727002
Citation
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.
Results Reference
derived
Learn more about this trial
Safety and Immunogenicity Study of the Hepatitis B Virus (HBV) Vaccine, HEPLISAV Compared to Engerix-B Vaccine
We'll reach out to this number within 24 hrs