Vaccination in Inflammatory Rheumatic Disease (VACCIMIL). The Impact of Antirheumatic Treatment on Antibody Response
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Region Skane
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- antibody response following vaccination
研究概览
简要总结
The overall objective of this project is to study the influence of modern anti-inflammatory treatments in established inflammatory rheumatic diseases (IRD) on immune response elicited by pneumococcal vaccination using 13-valent conjugate vaccine and influenza vaccination. In addition, the aim is to study the clinical aspects of vaccination regarding: tolerability in immunosuppressed patients with IRD, impact on existing rheumatic disease, possible association with onset of new autoimmune diseases, long-term immunity following pneumococcal vaccination, efficacy in preventing invasive pneumococcal diseases and influenza related serious infections. Results from this study are expected to bridge the existing knowledge gap and contribute to body of evidence needed for recommendations and implementation of vaccination program in IRD patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult patients with IRD receiving active anti-rheumatic treatments with DMARDs or biological remedies are offered to participate in the study. The protocol permits stratification for prednisolone usage, smoking habits and alcohol consumption.
排除标准
- •age <18 years;
- •pregnancy,
- •known intolerance of vaccine,
- •ongoing infection
研究组 & 干预措施
vaccinated controls
healthy controls immunized with 0,5 mg pneumococcal conjugate vaccine i.m.
干预措施: 0,5 mg seasonal influenza vaccine i.m. (Biological)
vaccinated patients
patients with different inflammatory rheumatic disease immunized with 0,5 mg pneumococcal conjugate vaccine i.m.
干预措施: 0,5 mg Prevenar i.m. (Biological)
vaccinated controls
healthy controls immunized with 0,5 mg pneumococcal conjugate vaccine i.m.
干预措施: 0,5 mg Prevenar i.m. (Biological)
vaccinated patients
patients with different inflammatory rheumatic disease immunized with 0,5 mg pneumococcal conjugate vaccine i.m.
干预措施: 0,5 mg seasonal influenza vaccine i.m. (Biological)
seasonal influenza vaccine
patients with different inflammatory rheumatic diseases immunized with 0,5 mg seasonal influenza vaccine i.m.
干预措施: 0,5 mg Prevenar i.m. (Biological)
seasonal influenza vaccine
patients with different inflammatory rheumatic diseases immunized with 0,5 mg seasonal influenza vaccine i.m.
干预措施: 0,5 mg seasonal influenza vaccine i.m. (Biological)
non-vaccinated controls
healthy controls immunized with 0,5 mg seasonal influenza vaccine i.m.
干预措施: 0,5 mg Prevenar i.m. (Biological)
non-vaccinated controls
healthy controls immunized with 0,5 mg seasonal influenza vaccine i.m.
干预措施: 0,5 mg seasonal influenza vaccine i.m. (Biological)
结局指标
主要结局
antibody response following vaccination
时间窗: 4-6 weeks after pneumococcal and influenza vaccination
measurement of antibody levels against different pneumococcal capsular serotypes and 3 influenza virus strains
次要结局
- long-term immunity following pneumococcal vaccination(3 years after pneumococcal vaccination)
- long-term immunity after vaccination with pneumococcal conjugate vaccine(5 years after vaccination)
研究者
meliha crnkic kapetanovic
MD, PhD, associate professor
Region Skane