RecruitingNCT01375530

Screening Volunteers for Clinical Trials

VRC 500: Screening Volunteers for Clinical Trials of Investigational Products and Licensed Products Evaluated for Research Purposes


Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Enrollment

4,000 participants

Start Date

Aug 16, 2011

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 60 Years

Inclusion Criteria3

  • 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

Exclusion Criteria3

  • 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

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Locations(4)

Emory University

Atlanta, Georgia, 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

University of Pennsylvania-UPenn

Philadelphia, Pennsylvania, United States

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NCT01375530


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