Evaluation of Vaccination Against Influenza (Seasonal and H1N1) in Patients Presenting Systemic or Autoimmune Diseases Treated or Not With Steroids, and/or Immunosuppressant, and/or Biotherapy: an Open, Prospective Trial (MAIVAX)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 234
- 试验地点
- 1
- 主要终点
- Protection against H1N1 influenza, defined by antibody level of 1/40, measured by hemagglutination, 3 weeks after the first injection and after the second injection
研究概览
简要总结
The project is to evaluate immunogenicity, efficacy and tolerance of vaccination against influenza (seasonal and H1N1) in patients affected with systemic and autoimmune diseases.
详细描述
This prospective study concentrates on patients with vasculitis, systemic sclerosis, Sjögren's syndrome, systemic lupus erythematosus and other connective tissue diseases.
Patients responding to the inclusion criteria, will receive vaccine against seasonal influenza then, 3 weeks later, vaccine against H1N1 influenza. According to the results of ongoing trials a second injection of H1N1 vaccine has been scheduled 3 weeks later. At each consultation a blood sample will be taken to evaluate immunogenicity of vaccination. Two additional consultations have been scheduled: one month after the last vaccine administration and at 6 month, in order to evaluate the occurrence of late side effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 否
入选标准
- •Adult patients presenting autoimmune and systemic diseases,
- •treating or not with steroids, and/or immunosuppressants and/or biotherapies, especially vasculitis, scleroderma, Sjogren's syndrome and systemic lupus (main groups)
排除标准
- •Absence of informed consent
- •Disease which did not responded to the above criteria
- •Active infection at time of vaccination
- •HIV infection
- •History of Guillain-Barre syndrome
- •Allergy to one component of the vaccine
研究组 & 干预措施
Evaluation of vaccines against flu
Evaluation of vaccines against flu
干预措施: Evaluation of vaccines against flu (Biological)
结局指标
主要结局
Protection against H1N1 influenza, defined by antibody level of 1/40, measured by hemagglutination, 3 weeks after the first injection and after the second injection
时间窗: 3 weeks
Mesure of antibody level of 1/40, measured by hemagglutination, 3 weeks after the first injection and after the second injection
次要结局
- Antibody levels against H1N1 in the different groups of patients, defined according diseases and their treatment (comparison of patients treated by immunosuppressants or not treated)(3 weeks)
- Number of side effects related to vaccination(3 weeks)
- Number of local side effects related to vaccination (erythema and/or pain at injection site)(3 weeks)
- Number of patients who will develop influenza despite vaccination(3 weeks)
- Number of patients who had antibodies against H1N1 before vaccination(3 weeks)
- Number of hospitalisations and deaths related to influenza(3 weeks)
- Number of flares of the autoimmune diseases that could be related to vaccination(3 weeks)
- Determine if the induction of LT-CD4 to J21-28 anti-jams is correlated to the concentrations of antibody anti-vaccines measured in 6 months(18 months)
- Determine if the basal concentrations of LT-CD4 anti-jam to J21-J28 are correlated to the concentrations of antibody anti-vaccines measured in 6 months(18 months)