Controlled Trial of Serologic Efficacy of Influenza Vaccine in Patients With Sarcoidosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Serologic Response (equal or more than 4 fold HI titer rise) to each of the 3 antigens of the trivalent vaccine of the 2008-9 influenza vaccine
研究概览
简要总结
The purpose of this study is to determine the efficacy of influenza vaccine (antibody response) in patients with sarcoidosis.
详细描述
Sarcoidosis is a multisystem disease with unclear etiology characterized by the presence of noncaseating granuloma[1]. T helper cells response is exaggerated at the site of disease and cellular immunity depressed in peripheral blood[2]. Cutaneous anergy, lymphopenia and inversion of CD4/CD8 ratio in peripheral blood suggest T helper cells involvement[3].
The action of humeral immune system in sarcoidosis is a matter of controversy. Standard hepatitis B virus vaccination did not provoke protective antibody titer in patients with sarcoidosis[3]. Although antibody response against influenza vaccine in patients with sarcoidosis is not well described, this vaccine is highly recommended in patients with chronic pulmonary diseases such as asthma, COPD and fibrosis [4, 5, 6]. In this study we aim to evaluate the humeral response to the influenza vaccine in sarcoidosis patients and assess vaccine safety.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Sarcoidosis patients:
- •Patients with relevant clinical, radiologic and histologic features of sarcoidosis (all stages).
- •Signed informed consent.
排除标准
- •Organ failure (kidney, heart, liver).
- •Collagen vascular diseases.
- •Diabetes.
- •Contraindications of vaccine (Egg allergy).
- •Patients who receive high dose (> 60 mg/day) steroid therapy.
- •Any acute disease.
- •Conditions accompanied by immunosuppression (like organ transplantation, HIV).
- •Any psychological disease that interferes with regular follow-up.
- •Inoculation with influenza vaccine within the past 5 years.
结局指标
主要结局
Serologic Response (equal or more than 4 fold HI titer rise) to each of the 3 antigens of the trivalent vaccine of the 2008-9 influenza vaccine
时间窗: 4-6 weeks
次要结局
- Magnitude of change in the antibody titer against each of the 3 antigenes of the trivalent vaccine of the 2008/2009 season [A/Brisbane/59/2007(HIN1)-like virus;A/Brisbane/10/2007(H3N2)-like virus;B/Florida/4/2006-like virus](4-6 weeks)
- Protective Antibody (equal or more than 1:40) titer after vaccination(4-6 weeks)
- Vaccine Safety (any major or minor side effects)(2 months)