Healthy Clinical Trial
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
NCT number | NCT01005407 |
Other study ID # | DV2-HBV-16 |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | February 2010 |
Est. completion date | May 2011 |
Verified date | March 2019 |
Source | Dynavax Technologies Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 2452 |
Est. completion date | May 2011 |
Est. primary completion date | January 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 40 Years to 70 Years |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Dynavax Technologies Corporation |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Percentage of Participants With Local and Systemic Reaction to Injections | within 7 days for post-injection reactions |
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