VRC 500: Screening Volunteers for Clinical Trials of Investigational Products and Licensed Products Evaluated for Research Purposes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 4,000
- 试验地点
- 5
- 主要终点
- To screen subjects for their eligibility to participate in clinical trials.
研究概览
简要总结
Background:
- The National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health needs healthy volunteers for vaccine clinical trials. This is a screening study that is used to identify healthy volunteers who may be eligible to participate in other clinical trials at the Vaccine Research Center that evaluate investigational vaccines, monoclonal antibodies, and injection devices. The VRC conducts studies that will allow researchers to better understand the immune system and how vaccines and monoclonal antibodies work.
Objectives:
- To screen healthy volunteers for clinical trials at the NIAID VRC.
Eligibility:
- Healthy people between 18 and 60 years of age. They must be available to take part in clinical trials and be able to provide blood for research studies.
Design:
- Screening for healthy volunteers to participate in clinical trials is an ongoing process.
- Volunteers will be asked about their medical history, including sexual activity and drug use, and a detailed physical exam will be performed.
- Blood and urine samples may be collected, and possibly other tests as needed to evaluate the volunteer's health status.
- Volunteers will not receive any investigational product in this screening protocol.
详细描述
The purpose of this study is to recruit and screen potential study subjects, mostly healthy volunteers, to determine if they are eligible for clinical trials of investigational products. This screening study also aims to characterize and analyze demographic information as well as laboratory and other medical findings in terms of how they may affect the eligibility of subjects for specific early phase clinical trials. All work will be conducted by the VRC Clinic of the National Institutes of Health or other IRB-approved sites that are collaborating with NIAID/VRC. Educational and recruitment materials on the investigational products and protocols will be
reviewed with and provided to subjects during participation in the screening protocol.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •INCLUSION CRITERIA:
- •Age: 18 years of age or older
- •Able and willing to complete the informed consent process
- •Agree to have blood and/or tissue samples collected and stored for future studies of investigational products, the immune system, and/or other medical conditions
排除标准
- •A condition in which repeated blood draws or injections pose more than minimal risk for the subject such as hemophilia, other severe coagulation disorders or significantly impaired venous access
- •A condition that requires active medical intervention or monitoring to avert serious danger to the participant s health or well-being
- •Known to be pregnant or breast-feeding
研究组 & 干预措施
1
Healthy adults 18 - 60 years old
结局指标
主要结局
To screen subjects for their eligibility to participate in clinical trials.
时间窗: Ongoing
Duration of subject participation is variable, and may last from a few weeks to several months for each subject.
次要结局
未报告次要终点