Back to resultsA Study of the Immune Response to Heplisav in Healthy Older Adults
Primary Purpose
Hepatitis B
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
HEPLISAV
Sponsored by
About this trial
This is an interventional basic science trial for Hepatitis B focused on measuring Heplisav
Eligibility Criteria
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
Sites / Locations
- Johnson County Clinical Trials
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
HEPLISAV
Arm Description
Outcomes
Primary Outcome Measures
Evaluate the changes in cellular responses and gene expression patterns in serial blood samples collected from healthy older adults after vaccination with HEPLISAV.
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT01999699
First Posted
November 26, 2013
Last Updated
March 18, 2019
Sponsor
Dynavax Technologies Corporation
Collaborators
Baylor Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT01999699
Brief Title
A Study of the Immune Response to Heplisav in Healthy Older Adults
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dynavax Technologies Corporation
Collaborators
Baylor Research Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B
Keywords
Heplisav
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HEPLISAV
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
HEPLISAV
Primary Outcome Measure Information:
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Janssen, MD
Organizational Affiliation
Dynavax Technologies Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Johnson County Clinical Trials
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66219
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
a/o August 2016, decision still pending.
Links:
URL
http://www.dynavax.com
Description
Related Info
Learn more about this trial
A Study of the Immune Response to Heplisav in Healthy Older Adults
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