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

NCT02958345 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2017-07-19

Study results available
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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.

Conditions

Interventions

BIOLOGICAL

Zostavax

Vaccination with one dose of Zostavax per Zostavax package insert

OTHER

Placebo

Injection of 0.65 mL of sterile normal saline

Sponsors & Collaborators

  • Tulane University

    lead OTHER

Principal Investigators

  • Luis Balart, MD · Tulane University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2015-07-31
Completion
2015-07-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02958345 on ClinicalTrials.gov