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

NCT02958345 | Completed Phase 4 Results

• 1 other identifier: 13-356128
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Herpes Zoster; Fibrosis

Outcome Measures

Primary Outcomes (1)

• ELISPOT, Interferon-G Enzyme-Linked Immunospot Assay

  Change in vitro cell-mediated immune response to varicella virus before and after vaccination in subjects receiving Zostavax™ versus those receiving placebo.

  Day 1 and 6 weeks

Secondary Outcomes (1)

• GPELISA, VZV Glycoprotein Enzyme-Linked Immunosorbent Assay (Aka Varicella Zoster Antibody Titre)

  Day 1 and 6 weeks

Study Arms (2)

Zostavax

ACTIVE COMPARATOR

Subjects will receive 0.65 mL of Zostavax subcutaneously in the deltoid region of the upper arm.

Biological: Zostavax

Placebo

PLACEBO COMPARATOR

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

Interventions

Zostavax BIOLOGICAL

Vaccination with one dose of Zostavax per Zostavax package insert

Also known as: Zoster Vaccine Live

Zostavax

Placebo OTHER

Injection of 0.65 mL of sterile normal saline

Placebo

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tulane University: lead

Related Publications (5)

• Oxman MN, Levin MJ, Johnson GR, Schmader KE, Straus SE, Gelb LD, Arbeit RD, Simberkoff MS, Gershon AA, Davis LE, Weinberg A, Boardman KD, Williams HM, Zhang JH, Peduzzi PN, Beisel CE, Morrison VA, Guatelli JC, Brooks PA, Kauffman CA, Pachucki CT, Neuzil KM, Betts RF, Wright PF, Griffin MR, Brunell P, Soto NE, Marques AR, Keay SK, Goodman RP, Cotton DJ, Gnann JW Jr, Loutit J, Holodniy M, Keitel WA, Crawford GE, Yeh SS, Lobo Z, Toney JF, Greenberg RN, Keller PM, Harbecke R, Hayward AR, Irwin MR, Kyriakides TC, Chan CY, Chan IS, Wang WW, Annunziato PW, Silber JL; Shingles Prevention Study Group. A vaccine to prevent herpes zoster and postherpetic neuralgia in older adults. N Engl J Med. 2005 Jun 2;352(22):2271-84. doi: 10.1056/NEJMoa051016.

  PMID: 15930418 BACKGROUND

• 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.

  PMID: 20863322 BACKGROUND

• Herrero JI, Quiroga J, Sangro B, Pardo F, Rotellar F, Alvarez-Cienfuegos J, Prieto J. Herpes zoster after liver transplantation: incidence, risk factors, and complications. Liver Transpl. 2004 Sep;10(9):1140-3. doi: 10.1002/lt.20219.

  PMID: 15350004 BACKGROUND

• Danziger-Isakov L, Heeger PS. Clinical utility of measuring T-cell immunity to CMV in transplant recipients. Am J Transplant. 2009 May;9(5):987-8. doi: 10.1111/j.1600-6143.2009.02599.x. No abstract available.

  PMID: 19422327 BACKGROUND

• Levin MJ, Oxman MN, Zhang JH, Johnson GR, Stanley H, Hayward AR, Caulfield MJ, Irwin MR, Smith JG, Clair J, Chan IS, Williams H, Harbecke R, Marchese R, Straus SE, Gershon A, Weinberg A; Veterans Affairs Cooperative Studies Program Shingles Prevention Study Investigators. Varicella-zoster virus-specific immune responses in elderly recipients of a herpes zoster vaccine. J Infect Dis. 2008 Mar 15;197(6):825-35. doi: 10.1086/528696.

  PMID: 18419349 BACKGROUND

MeSH Terms

Conditions

Herpes Zoster; Fibrosis

Interventions

Herpes Zoster Vaccine

Condition Hierarchy (Ancestors)

Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Luis Balart
• Organization: Tulane University

lbalart@tulane.edu

504-988-3047

Study Officials

• Luis Balart, MD

  Tulane University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2016
• First Posted: November 8, 2016
• Study Start: June 1, 2013
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: July 19, 2017
• Results First Posted: July 19, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share