Placebo Controlled Evaluation of the Cell Mediated Immune Response of Cirrhotic Subjects to Zostavax™
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 28
- 主要终点
- ELISPOT, Interferon-G Enzyme-Linked Immunospot Assay
研究概览
简要总结
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.
详细描述
Study aim, background, and design
Herpes Zoster (Shingles) is a major cause of pain and expense to the elderly and chronically ill. The incidence is estimated at 3 in 1,000 patients. Zostavax™ is a high dose, live varicella vaccine that has been validated in very large placebo control trials to reduce the incidence of Herpes Zoster rash and post herpetic neuralgia in patients over 50 years of age. Additionally the vaccine has been shown to increase quality of life in these patients. Symptomatic Herpes Zoster rates are particularly high post liver transplant with the 3-, 5-, and 10-year actuarial rates of Herpes Zoster of 3%, 10%, 14%, and 18%, respectively. Zostavax is currently recommended for patients prior to solid organ transplantation with no adult data in liver transplant candidates to support that practice. And Although cirrhosis has been acknowledged as a risk factor for symptomatic Herpes Zoster, there is no published data on the efficacy of Zostavax in chronically ill cirrhotic adults pre-transplantation. In particular, it is not known whether or not chronically ill cirrhotic patients demonstrate the appropriate age related cell-mediated immune response seen in the original Zostavax trials.
Procedure
The study will be divided into 3 parts: Screening, Day 1 (or administration of study drug), and Follow Up.
There will be a 4 week screening period. The following procedures will occur in Screening:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cirrhosis of any etiology diagnosed clinically by labs and imaging or by liver biopsy
- •Male or Female age 50 to 70
排除标准
- •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
结局指标
主要结局
ELISPOT, Interferon-G Enzyme-Linked Immunospot Assay
时间窗: 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.
次要结局
- GPELISA, VZV Glycoprotein Enzyme-Linked Immunosorbent Assay (Aka Varicella Zoster Antibody Titre)(Day 1 and 6 weeks)