Effects of Chronic Viral Infection on Immune Response to Zoster Vaccination

NCT02590068 | Terminated Results

• 2 other identifiers: OJE-08905U19AI111825-02
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (1)

• Serum Zoster Antibody Level

  Serum zoster antibody level would be measured by gpELISA expressed in (units/mL)

  18 months

Secondary Outcomes (4)

• Interferon Stimulated Gene (ISG) Expression

  18 months

• Serum Biomarkers of Immune Activation(Expressed in%)

  18 months

• Responder Cell Frequency

  18 months

• Interferon-gamma Response

  18 months

Study Arms (2)

Hepatitis C infected volunteers

EXPERIMENTAL

Zoster vaccine live (Zostavax), 0.65 ml dose, administered subcutaneously to Hepatitis C infected volunteers

Drug: Zoster vaccine live

Healthy volunteers

ACTIVE COMPARATOR

Zoster vaccine live (Zostavax), 0.65 ml dose, administered subcutaneously to healthy volunteers

Drug: Zoster vaccine live

Interventions

Zoster vaccine live DRUG

Single Zostavax vaccine, 0.65 ml dose, administered subcutaneously

Also known as: Zostavax

Healthy volunteers; Hepatitis C infected volunteers

Eligibility Criteria

• Age: 50 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rockefeller University: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Rockefeller University Hospital

New York, New York, 10065, United States

Location

Related Publications (22)

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• Schmader KE, Johnson GR, Saddier P, Ciarleglio M, Wang WW, Zhang JH, Chan IS, Yeh SS, Levin MJ, Harbecke RM, Oxman MN; Shingles Prevention Study Group. Effect of a zoster vaccine on herpes zoster-related interference with functional status and health-related quality-of-life measures in older adults. J Am Geriatr Soc. 2010 Sep;58(9):1634-41. doi: 10.1111/j.1532-5415.2010.03021.x.

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MeSH Terms

Conditions

Hepatitis C

Interventions

Herpes Zoster Vaccine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Chickenpox Vaccine; Herpesvirus Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Dr. Aileen O'Connell, Laboratory Manager
• Organization: The Rockefeller University

aoconnell@rockefeller.edu

212-327-7047

Study Officials

• Oyebisi Jegede, MBBS, PhD

  The Rockefeller University Center for Clinical and Translational Studies

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2015
• First Posted: October 28, 2015
• Study Start: December 1, 2015
• Primary Completion: September 8, 2017
• Study Completion: September 8, 2017
• Last Updated: December 18, 2019
• Results First Posted: December 18, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)