Dermal Priming in Enhancing Vaccine Immunogenicity
Understanding the Impact of Local Dermal Priming in Enhancing Vaccine Immunogenicity in Patients Receiving B Cell Depleting Immunosuppression
Experimental medicine study in patients receiving B cell depletion therapy administering an immune challenge with seasonal influenza vaccination with/without concurrent administration of topical imiquimod (TLR7 agonist) aiming to determine proof of concept that local dermal immune priming alters physiological parameters following immunisation in this context.
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Rona Smith, MD
- 电话号码：00441223217259
- 邮箱：rona.smith@nhs.net
学习地点
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Cambridge、英国
- 招聘中
- Cambridge University Hospitals NHS Foundation Trust
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Diagnosed with an autoimmune condition (including but not limited to ANCA associated vasculitis, IgG4 disease) and receiving B cell depletion therapy (eg, rituximab).
- Participant is willing and able to give informed consent for participation in the study.
Exclusion Criteria:
- Has received immunosuppression in addition to rituximab in the last 3 months (oral prednisolone at any dose is permitted)
- Rituximab within less than 5 months or more than 18 months of screening
- Receiving oral prednisolone at a dose > 5mg daily
- Has a diagnosis of systemic lupus erythematosus or Sjogren's syndrome
- Is currently pregnant
- Has a recent history (documented, confirmed or suspected) of a flu-like illness within a week of vaccination
- Receiving anticoagulation (including warfarin, DOACs, clopidogrel, ticagrelor) for any indication or having any coagulation disorder. Low dose daily aspirin is permitted
- A known allergy or contraindications to imiquimod or influenza vaccine or excipients
- Prior vaccination with the current seasonal influenza vaccine
- Have any condition that the investigator believes may interfere with successful completion of the study
学习计划
研究是如何设计的？
设计细节
- 主要用途：基础科学
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Group 1: topical imiquimod (5% Aldara) + influenza vaccine
Topical imiquimod (5% Aldara) + influenza vaccine |
Topical application at site of influenza vaccine administration
其他名称：
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安慰剂比较：Group 2: Topical placebo + influenza vaccine
Topical placebo + influenza vaccine |
Topical aqueous cream |
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假比较器：Group 3: topical imiquimod (5% Aldara) + saline (sham) vaccine
|
Topical application at site of influenza vaccine administration
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in influenza-specific antibody neutralising capacity
大体时间：Comparison between baseline and day 28
|
Comparison between patients that received imiquimod and placebo |
Comparison between baseline and day 28
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in influenza-specific antibody neutralising capacity
大体时间：day 90
|
Comparison between patients that received imiquimod and placebo |
day 90
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.