Screening Volunteers for Clinical Trials
- Conditions
- Screening
- Registration Number
- NCT01375530
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 4000
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To screen subjects for their eligibility to participate in clinical trials. Ongoing Duration of subject participation is variable, and may last from a few weeks to several months for each subject.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (4)
Emory University
🇺🇸Atlanta, Georgia, United States
University of Pennsylvania-UPenn
🇺🇸Philadelphia, Pennsylvania, United States
Univ of MD School of Medicine Center for Vaccine Development & Global Health
🇺🇸Baltimore, Maryland, United States
National Institutes of Health Clinical Center
🇺🇸Bethesda, Maryland, United States