2024-518191-31-00招募中4 期
Vaccination against respiratory syncytial virus in patients with inflammatory rheumatic diseases. The impact of anti-rheumatic treatments on the RSV immune response.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- Region Skane
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Antibody response, i.e. fold-change of RSVpreF-specific IgG antibody level from pre- to post-vaccination (3-6 weeks).
研究概览
简要总结
The primary objective of this trial is to assess if immunomodulating antirheumatic treatments including synthetic disease modifying anti-rheumatic drugs (DMARDs) such as methotrexate and different biological treatments (anti-TNF, anti IL6r, anti-IL12/23/17, anti-CD20, anti-BlyS, or targeted DMARDs (JAK-inhibitors)) impair the humoral immune response to one dose of RSV vaccine in IRD patients compared to immunocompetent controls.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •The subject has given their written consent to participate in the trial.
- •Age ≥60 years.
- •Having regular follow-up at rheumatology department in Lund, Malmö or Kristianstad
- •Receiving immunomodulating treatment for at least 3 months (only for patients)
排除标准
- •Immunodeficiency (not related to immunomodulating antirheumatic treatment)
- •Changes of immunomodulating treatment four weeks before the vaccination
- •Not willing to get vaccinated against RSV
- •Prior vaccination against RSV
- •Fever or ongoing infection
- •Hypersensitivity to the active substances or to any of the excipients of both RSV vaccines (Abrysvo and Arexvy).
结局指标
主要结局
Antibody response, i.e. fold-change of RSVpreF-specific IgG antibody level from pre- to post-vaccination (3-6 weeks).
Antibody response, i.e. fold-change of RSVpreF-specific IgG antibody level from pre- to post-vaccination (3-6 weeks).
次要结局
- Reported adverse events.
- Functional RSVpreF-antigen specific T-cell response.
研究者
Per Nived
Scientific
Region Skane
研究点 (2)
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