A Phase 1 Systems Biology Study to Investigate Immune Correlates of the Response to an Experimental Hepatitis B Vaccine (HEPLISAV) in Healthy Adults 50 to 70 Years of Age.
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Evaluate the changes in cellular responses and gene expression patterns in serial blood samples collected from healthy older adults after vaccination with HEPLISAV.
Study Overview
Brief Summary
This study will investigate the response of the immune system to a hepatitis B (HB) vaccine in healthy adults 50 to 70 years of age. This study is partially funded by the National Institute of Allergy and Infectious Diseases.
Detailed Description
The purpose of this study is to examine how the immune system responds to vaccination with HEPLISAV.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •50 to 70 years of age, inclusive
- •In good health in the opinion of the principal investigator, based upon medical history and physical examination
- •Serum negative for HBsAg, anti-HBs, antibody to hepatitis B core antigen (anti-HBc), hepatitis C virus (HCV), and human immunodeficiency virus (HIV)
- •If female of childbearing potential, agree to consistently use a highly effective method of birth control from the screening visit through Week 12/Visit 10
Exclusion Criteria
- •Pregnant, breastfeeding, or planning a pregnancy
- •Known history of an autoimmune disease
- •Previously received any hepatitis B vaccine (approved or investigational)
- •Body-mass index (BMI) >30 kg/m2, diabetes mellitus (type 1 or 2), or other chronic medical condition that in the opinion of the principal investigator might interfere with the immune response to hepatitis B vaccination
Arms & Interventions
HEPLISAV
Intervention: HEPLISAV (Biological)
Outcomes
Primary Outcomes
Evaluate the changes in cellular responses and gene expression patterns in serial blood samples collected from healthy older adults after vaccination with HEPLISAV.
Time Frame: Day 1, 3, and 7 and on Day 28
Determine which of these changes correlate with the development of protective levels of antibody (anti-HBs >/= 10 milli-international unit (mIU)/mL) to hepatitis B virus (HBV).
Time Frame: Day 1, 3, and 7 and on Day 28
Secondary Outcomes
No secondary outcomes reported