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Pilot Study: Gene Expression Profiling of Immune Response to HBV Vaccination in Healthy Volunteers

Primary Purpose

Hepatitis B

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hepatitis B Vaccine (Recombinant)
Sponsored by
Rockefeller University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hepatitis B focused on measuring Hepatitis B vaccine

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy volunteer without significant medical problems
  • Willing to receive three doses of an FDA-approved Hepatitis B vaccine

Exclusion Criteria:

  • 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

Sites / Locations

  • The Rockefeller University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hepatitis B vaccination

Arm Description

All subjects will receive the standard 3-dose course of Recombivax HB (Merck) - Hepatitis B Vaccine (Recombinant).

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
February 3, 2014
Last Updated
April 7, 2018
Sponsor
Rockefeller University
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1. Study Identification

Unique Protocol Identification Number
NCT02055365
Brief Title
Pilot Study: Gene Expression Profiling of Immune Response to HBV Vaccination in Healthy Volunteers
Official Title
Effects of Persistent Innate Immune Activation on Vaccine Efficacy Pilot Study: Gene Expression Profiling of Immune Response to HBV Vaccination in Healthy Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
February 18, 2014 (Actual)
Primary Completion Date
January 6, 2015 (Actual)
Study Completion Date
January 6, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rockefeller University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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. Knowledge of those genes and cellular functions activated by effective vaccination can improve our understanding of how the immune system works and define the features necessary for a successful vaccine response. This study aims to define cellular functions important for the hepatitis B (HBV) vaccine immune response in healthy individuals. The investigators will identify those genes that are activated or suppressed in immune cells at various times after each dose of the HBV vaccine. The investigators will explore these vaccine-induced "gene signatures" to characterize the cellular functions associated with an effective immune response to HBV vaccination. The investigators hypothesize that many genes associated with innate and adaptive immune functions are important for an effective HBV vaccine response.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B
Keywords
Hepatitis B vaccine

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hepatitis B vaccination
Arm Type
Experimental
Arm Description
All subjects will receive the standard 3-dose course of Recombivax HB (Merck) - Hepatitis B Vaccine (Recombinant).
Intervention Type
Biological
Intervention Name(s)
Hepatitis B Vaccine (Recombinant)
Other Intervention Name(s)
Recombivax HB - Merck & Co., Inc.
Intervention Description
All subjects will receive the standard 3-dose course of Recombivax HB (Merck) - Hepatitis B Vaccine (Recombinant).
Primary Outcome Measure Information:
Title
Number of Differentially Expressed Genes at p < 0.05 (Without Multiple Testing Correction).
Description
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.
Time Frame
Day 1, Day 3, Week 1, and Week 2
Title
Number of Significantly Differentially Expressed Genes at False Discovery Rate (FDR)< 0.05 (Upon Correction for Multiple Testing).
Description
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.
Time Frame
Day 1, Day 3, Week 1, and Week 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy volunteer without significant medical problems Willing to receive three doses of an FDA-approved Hepatitis B vaccine Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brad Rosenberg, MD, PhD
Organizational Affiliation
The Rockefeller University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Rockefeller University
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

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Pilot Study: Gene Expression Profiling of Immune Response to HBV Vaccination in Healthy Volunteers

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