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

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ClinicalTrials.gov Identifier: NCT02055365
Recruitment Status : Completed
First Posted : February 5, 2014
Results First Posted : April 5, 2018
Last Update Posted : May 7, 2018
Sponsor:
Information provided by (Responsible Party):
Brad Rosenberg, Rockefeller University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hepatitis B Biological: Hepatitis B Vaccine (Recombinant) Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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
Actual Study Start Date : February 18, 2014
Actual Primary Completion Date : January 6, 2015
Actual Study Completion Date : January 6, 2015

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Hepatitis B vaccination
All subjects will receive the standard 3-dose course of Recombivax HB (Merck) - Hepatitis B Vaccine (Recombinant).
 Biological: Hepatitis B Vaccine (Recombinant)
All subjects will receive the standard 3-dose course of Recombivax HB (Merck) - Hepatitis B Vaccine (Recombinant).
Other Name: Recombivax HB - Merck & Co., Inc.


Outcome Measures
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Primary Outcome Measures :
  1. Number of Differentially Expressed Genes at p < 0.05 (Without Multiple Testing Correction). [ Time Frame: Day 1, Day 3, Week 1, and Week 2 ]
    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.

  2. Number of Significantly Differentially Expressed Genes at False Discovery Rate (FDR)< 0.05 (Upon Correction for Multiple Testing). [ Time Frame: Day 1, Day 3, Week 1, and Week 2 ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02055365


Locations
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United States, New York
The Rockefeller University
New York, New York, United States, 10065
Sponsors and Collaborators
Rockefeller University
Investigators
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Principal Investigator: Brad Rosenberg, MD, PhD The Rockefeller University
More Information
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Responsible Party: Brad Rosenberg, Whitehead Presidential Fellow, Rockefeller University
ClinicalTrials.gov Identifier: NCT02055365    
Other Study ID Numbers: BRO-0828
First Posted: February 5, 2014    Key Record Dates
Results First Posted: April 5, 2018
Last Update Posted: May 7, 2018
Last Verified: April 2018
Keywords provided by Brad Rosenberg, Rockefeller University:
Hepatitis B vaccine
Additional relevant MeSH terms:
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Hepatitis B
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
 Infections
Blood-Borne Infections
Communicable Diseases
Hepadnaviridae Infections
DNA Virus Infections