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Placebo Controlled Evaluation of the Cell Mediated Immune Response of Cirrhotic Subjects to Zostavax™

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ClinicalTrials.gov Identifier: NCT02958345
Recruitment Status : Completed
First Posted : November 8, 2016
Results First Posted : July 19, 2017
Last Update Posted : July 19, 2017
Sponsor:
Information provided by (Responsible Party):
Tulane University

Brief Summary:

Study Design:

Double-blinded, placebo controlled study of the efficacy of Zostavax in cirrhosis.

Subjects will receive either Zostavax or placebo and will be followed for four months.

Hypothesis:

The investigators hypothesize Zostavax would induce cell-based immunity in cirrhotic patients like that seen in elderly patients.


Condition or disease Intervention/treatment Phase
Herpes Zoster Fibrosis Biological: Zostavax Other: Placebo Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Placebo Controlled Evaluation of the Cell Mediated Immune Response of Cirrhotic Subjects to Zostavax™
Study Start Date : June 2013
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shingles

Arm Intervention/treatment
Active Comparator: Zostavax
Subjects will receive 0.65 mL of Zostavax subcutaneously in the deltoid region of the upper arm.
Biological: Zostavax
Vaccination with one dose of Zostavax per Zostavax package insert
Other Name: Zoster Vaccine Live

Placebo Comparator: Placebo
Subjects randomized to placebo will receive an injection of 0.65 mL of sterile normal saline subcutaneously in the deltoid region of the upper arm.
Other: Placebo
Injection of 0.65 mL of sterile normal saline




Primary Outcome Measures :
  1. ELISPOT, Interferon-G Enzyme-Linked Immunospot Assay [ Time Frame: Day 1 and 6 weeks ]
    Change in vitro cell-mediated immune response to varicella virus before and after vaccination in subjects receiving Zostavax™ versus those receiving placebo.


Secondary Outcome Measures :
  1. GPELISA, VZV Glycoprotein Enzyme-Linked Immunosorbent Assay (Aka Varicella Zoster Antibody Titre) [ Time Frame: Day 1 and 6 weeks ]
    Change in pre and post vaccination Varicella Zoster Virus



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Cirrhosis of any etiology diagnosed clinically by labs and imaging or by liver biopsy
  • Male or Female age 50 to 70

Exclusion Criteria:

  • Active or history of Herpes Zoster
  • Anaphylactic allergy to neomycin or gelatin
  • Immunosuppressive medication use
  • Antiviral medication use
  • Known history of HIV
  • Known immune deficiency disease
  • Active on a liver transplant list
  • Known malignancy other than non-melanomatous skin cancer within the past five years.
  • History of vaccination with varicella or zoster vaccine
  • Pregnant or lactating women
  • Prisoners
  • Post-transplant patient
  • Acute illness

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): NCT02958345


Sponsors and Collaborators
Tulane University
Investigators
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Principal Investigator: Luis Balart, MD Tulane University

Publications:

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Responsible Party: Tulane University
ClinicalTrials.gov Identifier: NCT02958345     History of Changes
Other Study ID Numbers: 13-356128
First Posted: November 8, 2016    Key Record Dates
Results First Posted: July 19, 2017
Last Update Posted: July 19, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Herpes Zoster
Varicella Zoster Virus Infection
Herpesviridae Infections
DNA Virus Infections
Virus Diseases