Combined Pneumococcal Conjugate and Polysaccharide Vaccination in Inflammatory Rheumatic Disease. Impact of Antirheumatic Treatment on Antibody Response.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Region Skane
- 入组人数
- 300
- 主要终点
- 2-fold rise in pneumococcal serotype-specific antibody concentration
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 antibody response elicited by pneumococcal vaccination using 13-valent conjugate vaccine in combined schedules with 23-valent polysaccharide vaccine. 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 and efficacy in preventing invasive pneumococcal disease. 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
- Prevention
- 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.
排除标准
- •known allergy/intolerance of pneumococcal vaccine
- •pregnancy
- •active infection
研究组 & 干预措施
PPV23-booster to previous PCV-vaccinated controls
Healthy controls previously immunized with one dose PCV7 or PCV13 within another study (see VACCIMIL), are immunized with one dose PPV23 0.5 ml i.m.
干预措施: 23-valent pneumococcal polysaccharide vaccine (Biological)
PCV13 to previous PPV23-vaccinated patients
Patients with different inflammatory rheumatic disease previously immunized with one dose PPV23 within another study (see VACCIMIL), are immunized with one dose PCV13 0.5 ml i.m.
干预措施: 13-valent pneumococcal conjugate vaccine (Biological)
PPV23-booster to previous PCV-vaccinated patients
Patients with different inflammatory rheumatic disease previously immunized with one dose PCV7 or PCV13 within another study (see VACCIMIL), are immunized with one dose PPV23 0.5 ml i.m.
干预措施: 23-valent pneumococcal polysaccharide vaccine (Biological)
PCV13+PPV23 vaccinated controls
Healthy controls are immunized with one dose 13-valent pneumococcal conjugate vaccine 0.5 ml i.m., followed by one dose 23-valent pneumococcal polysaccharide vaccine 0.5 ml i.m. after 8 weeks.
干预措施: 23-valent pneumococcal polysaccharide vaccine (Biological)
PCV13+PPV23 vaccinated controls
Healthy controls are immunized with one dose 13-valent pneumococcal conjugate vaccine 0.5 ml i.m., followed by one dose 23-valent pneumococcal polysaccharide vaccine 0.5 ml i.m. after 8 weeks.
干预措施: 13-valent pneumococcal conjugate vaccine (Biological)
PCV13+PPV23 vaccinated patients
Patients with different inflammatory rheumatic diseases are immunized with one dose 13-valent pneumococcal conjugate vaccine 0.5 ml i.m., followed by one dose 23-valent pneumococcal polysaccharide vaccine 0.5 ml i.m. after 8 weeks.
干预措施: 23-valent pneumococcal polysaccharide vaccine (Biological)
PCV13+PPV23 vaccinated patients
Patients with different inflammatory rheumatic diseases are immunized with one dose 13-valent pneumococcal conjugate vaccine 0.5 ml i.m., followed by one dose 23-valent pneumococcal polysaccharide vaccine 0.5 ml i.m. after 8 weeks.
干预措施: 13-valent pneumococcal conjugate vaccine (Biological)
结局指标
主要结局
2-fold rise in pneumococcal serotype-specific antibody concentration
时间窗: 8 weeks after pneumococcal conjugate vaccine and 4-6 weeks after polysaccharide vaccination
Pneumococcal serotype-specific antibody concentration (12-valent)
次要结局
- Long-term serotype-specific immunity to pneumococcal disease(3 years after vaccination)
- Functional antibody response(8 weeks after pneumococcal conjugate vaccine and 4-6 weeks after polysaccharide vaccination)