Effects of Persistent Innate Immune Activation on Vaccine Efficacy
Condition: Hepatitis C Infection
MeSH terms: Hepatitis C
Intervention: Recombivax
Intervention description: Injection of Recombivax HBV vaccine administered IM, at 0, 1, and 6 months after enrollment
Intervention MeSH terms: Vaccines
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 62 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will investigate the effects of chronic HCV infection and corresponding innate
      immune activation on the immune response to HBV vaccination. We will recruit chronic HCV
      patients and healthy control patients for HBV vaccination. We will use RNA Sequencing
      (RNA-Seq), a relatively new technology for simultaneously measuring the expression of all
      genes, to determine patients' innate immune status, and learn how this innate immune
      signature is related to HBV vaccine response. We will then explore the mechanisms by which
      chronic HCV infection affects different immune cells and functions that are known to be
      important for an effective HBV vaccine response. These studies will enhance our understanding
      of the immune effects of chronic viral infection, establish factors that determine effective
      vaccine responses, and help guide vaccination strategies for HCV patients and other
      individuals with chronic inflammatory disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Willing to receive three doses of an FDA-approved Hepatitis B vaccine

          -  Volunteer chronically infected with HCV (as demonstrated by serology and/or viral load
             laboratory studies)

          -  Healthy volunteer without significant medical problems

        Exclusion Criteria:

          -  Received any vaccine within a month prior to study vaccine

          -  Positive serum antibody against Hep B surface antigen and/or core Hep B core antigen

          -  HIV positive

          -  For HCV-negative, healthy volunteers: 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

          -  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 (in addition to HCV
             infection, for HCV group)

          -  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 156 weeks

          -  History of previous Hepatitis B vaccination(s)

          -  Male or female < 18 and > 62 years of age

          -  Is pregnant or lactating

          -  History of Hepatitis B infection

          -  Clinical, laboratory, or biopsy evidence of cirrhosis