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
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.
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
Active Comparator: Zostavax
Subjects will receive 0.65 mL of Zostavax subcutaneously in the deltoid region of the upper arm.
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.
Injection of 0.65 mL of sterile normal saline
- 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.
- 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
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
|Principal Investigator:||Luis Balart, MD||Tulane University|