A Phase I Study to Determine the Safety and Immunogenicity of the Candidate Influenza Vaccine ChAdOx1-NP+M1
2014年12月1日 更新者:University of Oxford
This is a first in man dose escalation study, to assess the safety and immunogenicity of the candidate influenza vaccine ChAdOx1-NP+M1.
All volunteers recruited will be healthy adults aged 18-50.
Volunteers will be enrolled and doses will be escalated according to a "3+3" study plan.
Up to 24 volunteers will be vaccinated.
Following one dose of the vaccine, volunteers will be followed up to assess the side effect profile of the vaccine and to take blood tests.
A series of immunology assays will be performed to determine how potent the vaccine is at inducing an immune response.
研究概览
研究类型
介入性
注册 (实际的)
15
阶段
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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-
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Oxford、英国、OX3 7LE
- Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 50年 (成人)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
The volunteer must satisfy all the following criteria to be eligible for the study:
- Men and women aged 18-50
- Resident in or near Oxford for the duration of the vaccination study
- Able and willing (in the Investigators' opinions) to comply with all study requirements
- Willing to allow the investigators to discuss the volunteer's medical history with their General Practitioner
- Willingness to use effective contraception for 4 weeks from the date of vaccination
- Agreement to refrain from blood donation for 4 weeks from the date of vaccination
- Written informed consent
Exclusion Criteria:
The volunteer may not enter the study if any of the following apply:
- Participation in another research study involving an investigational product in the 30 days preceding enrolment, or planned use during the study period
- Previous receipt of any recombinant adenoviral vectored vaccine
- Previous receipt of MVA-NP+M1
- Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate
- Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication within the past 6 months (inhaled/topical steroids are allowed)
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine
- Any history of anaphylaxis in reaction to vaccination
- History of cancer (except basal cell carcinoma and cervical carcinoma in situ)
- History of serious psychiatric condition
- Any chronic illness requiring ongoing or awaiting hospital specialist supervision, other than minor surgical procedures and follow up of surgery over 6 months prior to screening.
- Suspected or known current injecting drug or alcohol abuse (as defined by an alcohol intake of greater than 42 units every week)
- Seropositive for hepatitis B surface (HBsAg) or hepatitis C virus (antibodies to HCV)
- Pregnancy, lactation or willingness/intention to become pregnant during the study
- Any other significant disease, disorder or finding (including blood test results), which, in the opinion of the Investigators, would either put the volunteer at risk because of participation in the study, or may influence the result of the study.
- No response / confirmation from GP regarding previous medical history
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:ChAdOx1-NP+M1
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Dose escalation in a 3+3 study plan; 5 x10^8 vp, 5 x10^9 vp, 2.5 x10^10 vp, 5 x10^10 vp |
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 |
|---|---|---|
|
Safety
大体时间:3 weeks
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Analysis of data on adverse events.
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3 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Reactogenicity
大体时间:3 weeks
|
Immunogenicity endpoints will include interferon-gamma ELISpot as a marker of cell-mediated immunity.
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3 weeks
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Adrian Hill, MD、University of Oxford
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2012年6月1日
初级完成 (实际的)
2013年3月1日
研究完成 (实际的)
2013年3月1日
研究注册日期
首次提交
2012年6月13日
首先提交符合 QC 标准的
2012年6月15日
首次发布 (估计)
2012年6月20日
研究记录更新
最后更新发布 (估计)
2014年12月2日
上次提交的符合 QC 标准的更新
2014年12月1日
最后验证
2014年11月1日
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.