Prospective Cohort Study to Determine the Response to COVID-19 Vaccination and Prevalence of COVID-19 in Subjects With Chronic Liver Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 233
- 试验地点
- 1
- 主要终点
- Prevalence of SARSCOV-2 in subjects with chronic liver disease
研究概览
简要总结
Background:
The COVID-19 global pandemic killed more than 6 million people worldwide. Several vaccines have been developed against the virus that causes this disease. These vaccines are effective at preventing severe symptoms and death from COVID-19. Some people with chronic liver disease, especially those with an advanced condition called cirrhosis, do not respond to many vaccines as well as healthy people do. The goal of this natural history study is to find out how well people with chronic liver disease respond to the COVID-19 vaccines.
Objective:
To learn how chronic liver disease affects the body s immune response to vaccination against COVID-19.
Eligibility:
People aged 18 years or older with chronic liver disease. They must also be enrolled in protocol 91-DK-0214 or 18-DK-0091.
Design:
Participants will have 3 visits, each spaced 6 months apart. Each visit will last 2 hours.
Participants will have their vital signs recorded. These include age, sex, race, height, and weight. They will give their medical history.
At each visit, participants will have blood drawn through a needle inserted into a vein in the arm. The sample drawn at each visit will be from 1 to 8 tablespoons.
At each visit, participants will fill out a questionnaire. They will answer questions about whether they have been vaccinated against COVID-19; whether they have had COVID-19; and whether they have been exposed to someone who had COVID-19. The questionnaire will take 10 to 15 minutes.
Researchers will also look at results of past blood tests from other research studies.
详细描述
Study Description:
The goals of this study are to assess the response to COVID vaccination in patients with chronic liver disease. Secondary goals are to evaluate the durability of antibody response against SARSCOV-2 and if SARS-COV-2 seropositivity is associated with reactivation or worsening of chronic hepatitis B.
Hypothesis:
Subjects with cirrhosis will have poorer response to COVID vaccination compared to subjects without cirrhosis and to healthy controls.
Objectives:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •INCLUSION CRITERIA:
- •In order to participate in this study, an individual must meet all of the following criteria:
- •Male or females >= 18 years of age
- •Evidence of chronic liver disease within the last 12 months.
- •a. Patients with chronic hepatitis B who became negative for HBsAg will be eligible because they may reactivate following SARS-COV-2 exposure.
- •Enrolled in protocol 91-DK-0214 or 18-DK-0091
排除标准
- •An individual who meets any of the following criteria will be excluded from participation in this study:
- •History of only resolved chronic Hepatitis C (anti-HCV positive, HCV RNA negative) with no evidence of any other chronic liver disease, unless cirrhotic or unless prior cryopreserved peripheral blood mononuclear cells (PBMC) available.
- •Inability to provide informed consent
- •Patients with primary immunodeficiency disorders
- •Presence of conditions that, in the opinion of the investigators, would not allow the patient to be followed in the current study
研究组 & 干预措施
Standard
Chronic liver disease
结局指标
主要结局
Prevalence of SARSCOV-2 in subjects with chronic liver disease
时间窗: ongoing
To determine the response to SARS-COV-2 vaccination among patients with chronic liver disease stratified by severity (cirrhosis vs no cirrhosis) and compare to healthy controls
次要结局
- To determine the durability of antibody against SARS-COV-2 among patients with chronic liver disease.(ongoing)
- To determine if SARS-COV-2 seropositivity is associated with reactivation or worsening of chronic hepatitis B.(ongoing)