A Study of the Immune Response to Heplisav in Healthy Older Adults
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.
1 other identifier
interventional
25
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Nov 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2013
CompletedFirst Submitted
Initial submission to the registry
November 26, 2013
CompletedFirst Posted
Study publicly available on registry
December 3, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedMarch 20, 2019
March 1, 2019
1.3 years
November 26, 2013
March 18, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Evaluate the changes in cellular responses and gene expression patterns in serial blood samples collected from healthy older adults after vaccination with HEPLISAV.
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).
Day 1, 3, and 7 and on Day 28
Study Arms (1)
HEPLISAV
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dynavax Technologies Corporationlead
- Baylor Research Institutecollaborator
Study Sites (1)
Johnson County Clinical Trials
Lenexa, Kansas, 66219, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Robert Janssen, MD
Dynavax Technologies Corporation
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 26, 2013
First Posted
December 3, 2013
Study Start
November 1, 2013
Primary Completion
February 1, 2015
Study Completion
March 1, 2015
Last Updated
March 20, 2019
Record last verified: 2019-03