Effects of Chronic Viral Infection on Immune Response to Zoster Vaccination

• Status: Terminated
• Trial end date: 2017-09-08
• Target enrollment: 0
• Participant gender: All

Summary

This study aims to identify the innate and adaptive immune response to zoster vaccination. Half of the participants will be individuals with chronic hepatitis C, while the other half with healthy volunteers.The innate immune signature elicited by Zoster vaccination will be characterized by RNA-seq analysis of pre- and post-vaccination RNA from whole blood. We will compare fold changes in gene expression profiles pre- versus post-vaccination in each individual, as well as between the two arms of the study. RNA-seq will be used to assess innate immune activation by evaluating the changes to the expression levels of interferon-stimulated genes pre- and post-vaccination. Adaptive immune response will be determined by the traditional correlates of protection used in previous Zoster clinical studies in addition to flow cytometry24. Correlates of protection include antibody response, interferon gamma production and the frequency of responder cells post- vaccination24. For antibody production, we will perform Zoster glycoprotein ELISA (gpELISA) targeting IgG/IgM. The number and frequency of responder cells will be characterized by flow cytometry.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Rockefeller University
• Collaborator: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Vaccines

Criteria

Inclusion Criteria:

• Willing to receive the herpes zoster vaccine

• Volunteer chronically infected with HCV (as demonstrated by serology testing and have a viral load >1000 copies) without treatment

• Healthy volunteer without significant medical problems

Exclusion Criteria:

• Received any vaccine within a month prior to study vaccine

• Previous Zoster infection as an adult, >18 years

• HIV or Hepatitis B virus infection in the HCV and healthy arms

• 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 particpation 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

• Male or female < 50 and > 70 years of age

• Is pregnant or lactating

• Clinical, laboratory, or biopsy evidence of cirrhosis

• Allergy to gelatin and/or neomycin

• ALT and/or AST > 3.5 times the ULN

• Immunosuppressed or immunodeficient individuals including those with a history of primary or acquired immunodeficiency states, leukemia, lymphoma or other malignant neoplasms affecting the bone marrow or lymphatic system and those on immunosuppressive therapy

• Individuals with active untreated tuberculosis

• Prior Varicella vaccination

• HCV volunteers who have a viral load of <1000 copies