Trial record 64 of 439 for:    hepatitis b | Open Studies

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Rockefeller University
Sponsor:
Information provided by (Responsible Party):
Brad Rosenberg, Rockefeller University
ClinicalTrials.gov Identifier:
NCT02055365
First received: February 3, 2014
Last updated: February 4, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Healthy Subjects
Hepatitis B
Biological: Hepatitis B Vaccine (Recombinant)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Rockefeller University:

Primary Outcome Measures:
  • Detectable changes in PBMC gene expression levels [ Time Frame: Baseline, and days 1, 3, 7, and 14 ] [ Designated as safety issue: No ]
    Measurement of transcriptome-wide gene expression changes in RNA extracted from peripheral blood mononuclear cells (PBMCs) at indicated time point in HBV vaccine series.


Estimated Enrollment: 8
Study Start Date: February 2014
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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 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
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02055365

Contacts
Contact: Lauren Corregano 1-800-782-2737 rucares@rockefeller.edu

Locations
United States, New York
The Rockefeller University Recruiting
New York, New York, United States, 10065
Contact: Lauren Corregano    800-782-2737    rucares@rockefeller.edu   
Sponsors and Collaborators
Rockefeller University
Investigators
Principal Investigator: Brad Rosenberg, MD, PhD The Rockefeller University
  More Information

No publications provided

Responsible Party: Brad Rosenberg, Whitehead Presidential Fellow, Rockefeller University
ClinicalTrials.gov Identifier: NCT02055365     History of Changes
Other Study ID Numbers: BRO-0828
Study First Received: February 3, 2014
Last Updated: February 4, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Rockefeller University:
Hepatitis B vaccine

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections

ClinicalTrials.gov processed this record on September 14, 2014