Pilot Study: Gene Expression Profiling of Immune Response to HBV Vaccination in Healthy Volunteers
Effects of Persistent Innate Immune Activation on Vaccine Efficacy Pilot Study: Gene Expression Profiling of Immune Response to HBV Vaccination in Healthy Volunteers
1 other identifier
interventional
10
1 country
1
Brief Summary
Vaccines have been responsible for preventing millions of deaths and extending the average human lifespan. Effective vaccines stimulate the cells of the immune system to activate genes and associated functions that bring about protective immunity.This study aims to define cellular functions and genes important for the hepatitis B (HBV) vaccine immune response in healthy individuals. The investigators hypothesize that many genes associated with innate and adaptive immune functions are important for an effective HBV vaccine response.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2014
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
First Submitted
Initial submission to the registry
February 3, 2014
CompletedFirst Posted
Study publicly available on registry
February 5, 2014
CompletedStudy Start
First participant enrolled
February 18, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 6, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 6, 2015
CompletedResults Posted
Study results publicly available
April 5, 2018
CompletedMay 7, 2018
April 1, 2018
11 months
February 3, 2014
January 18, 2018
April 7, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Differentially Expressed Genes at p < 0.05 (Without Multiple Testing Correction).
Number of differentially expressed genes at time point versus prevaccination baseline (p\<0.05). Following Principal Components Analysis, data from one participant series was identified as a technical outlier and excluded from downstream analyses. Differential gene expression analysis was conducted with the voom/limma tools in the R statistical framework.
Day 1, Day 3, Week 1, and Week 2
Number of Significantly Differentially Expressed Genes at False Discovery Rate (FDR)< 0.05 (Upon Correction for Multiple Testing).
Number of significantly differentially expressed genes at time point versus prevaccination baseline (FDR\<0.05). Following Principal Components Analysis, data from one participant series was identified as a technical outlier and excluded from downstream analyses. Differential gene expression analysis was conducted with the voom/limma tools in the R statistical framework.
Day 1, Day 3, Week 1, and Week 2
Study Arms (1)
Hepatitis B vaccination
EXPERIMENTALAll subjects will receive the standard 3-dose course of Recombivax HB (Merck) - Hepatitis B Vaccine (Recombinant).
Interventions
All subjects will receive the standard 3-dose course of Recombivax HB (Merck) - Hepatitis B Vaccine (Recombinant).
Eligibility Criteria
You may qualify if:
- Healthy volunteer without significant medical problems
- Willing to receive three doses of an FDA-approved Hepatitis B vaccine
You may not qualify if:
- Male or female \< 18 and \> 60 years of age
- Received any vaccine within a month prior to study vaccine
- History of Hepatitis B infection
- History of previous Hepatitis B vaccination(s)
- History of Hepatitis C virus (HCV) infection or positive HCV antibody test
- Participation in another clinical study of an investigational product currently or within the past 90 days, or expected participation during this study
- Positive serum antibody against Hep B surface antigen and/or core Hep B core antigen
- human immunodeficiency virus (HIV) positive
- In the opinion of the investigator, the volunteer is unlikely to comply with the study protocol
- Any clinically significant abnormality or medical history or physical examination including history of immunodeficiency or autoimmune disease
- Is pregnant or lactating
- Currently taking systemic steroids or other immunomodulatory medications including anticancer medications and antiviral medications
- Any clinically significant acute or chronic medical condition requiring care by a primary care provider (e.g., diabetes, coronary artery disease, rheumatologic illness, malignancy, substance abuse) that, in the opinion of the investigator, would preclude participation
- Unable to continue participation for 30 weeks
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Rockefeller University
New York, New York, 10065, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Although RNA-Seq analysis was effective in measuring gene expression levels, additional study subjects (more samples) may have improved statistical power to detect subtle changes in gene expression over time post-vaccination.
Results Point of Contact
- Title
- Brad Rosenberg, MD, PhD
- Organization
- Icahn School of Medicine at Mount Sinai
Study Officials
- PRINCIPAL INVESTIGATOR
Brad Rosenberg, MD, PhD
The Rockefeller University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Whitehead Presidential Fellow
Study Record Dates
First Submitted
February 3, 2014
First Posted
February 5, 2014
Study Start
February 18, 2014
Primary Completion
January 6, 2015
Study Completion
January 6, 2015
Last Updated
May 7, 2018
Results First Posted
April 5, 2018
Record last verified: 2018-04