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临床试验/NCT01002508
NCT01002508Unknown4 期

Safety and Efficacy of Vaccination Against Influenza in Patients With Scleroderma

Tel-Aviv Sourasky Medical Center2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2009年11月最近更新:
适应症

试验速览

阶段
4 期
入组人数
80
试验地点
2
主要终点
The number of subjects who achieve a titer of antibodies above 1/40

研究概览

简要总结

The safety and efficacy of vaccination against influenza in patients with scleroderma is not clear. The objective of this study is to assess its safety and efficacy in 50 patients with scleroderma in comparison with 30 controls

详细描述

Fifty patients with scleroderma and 30 healthy , aged matched controls will participate in the study.

After signing informed consent, all subjects will be vaccinated with the inactivated split virion vaccine which recommended by the WHO this fall.

Patients will be evaluated at weel 0 and 6 weeks later. Clinical evaluation will be based on the modified Rodnan score, number of digital ischemic ulcers, presence of gastrointestinal and respiratory symptoms, number of swollen and tender joints, visual global evaluation of the physician , ESR and CRP Blood with be collected on the day of vaccination and 6 weeks later.

The immunogenicity of the vaccine will be tested by Haemagglutination inhibition (HI) test.

Influenza virus has two important surface glycoproteins: the haemagglutinin (HA) and the neuraminidase (NA). Antigenic classification and subtyping of influenza viruses is based on these two glycoproteins. HA plays a key role in virus cell entry by binding to cell surface receptors, which are found also on red blood cells of certain species. Binding to red cells results in haemagglutination, which can be observed as a carpet of agglutinated red cells at the bottom of a tube or microtitre well. In the HI test, antibody directed against the viral haemagglutinins block the virus from binding to the blood cells and thus inhibits the haemagglutination reaction.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
16 Years 至 90 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients >18 year old age
  • Capable to sign a informed consent
  • Suffering from scleroderma

排除标准

  • Known allergy to influenza vaccine
  • Allergy to eggs

结局指标

主要结局

The number of subjects who achieve a titer of antibodies above 1/40

时间窗: 6 weeks

次要结局

  • Number of patients with an increased Rodnan Score(6 weeks)

研究者

申办方类型
Other Gov

研究点 (2)

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Influenza Vaccination in Patients With Scleroderma | 临床试验