Phase 4 Completed N=28 Randomized Double-blind Prevention

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

Herpes Zoster · Fibrosis

Source: ClinicalTrials.gov NCT02958345 ↗

Enrolled (actual)

Serious AEs

21.4%

Results posted

Jul 2017

Primary outcomePrimary: ELISPOT, Interferon-G Enzyme-Linked Immunospot Assay — 0; 0

◆ Published Evidence

No publication linked

No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY ELISPOT, Interferon-G Enzyme-Linked Immunospot Assay	0; 0	—
SECONDARY GPELISA, VZV Glycoprotein Enzyme-Linked Immunosorbent Assay (Aka Varicella Zoster Antibody Titre)	0; 0	—

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02958345). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.