Screening Volunteers for Clinical Trials

Screening Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01375530
• Other study ID #: 110164
• Secondary ID: 11-I-0164
• Status: Recruiting
• Start date: August 16, 2011

Study information

• Verified date: May 21, 2024
• Source: National Institutes of Health Clinical Center (CC)
• Contact: VRC Recruitment
• Phone: (866) 833-5433
• Email: vrcrecruitment[@]mail.nih.gov
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 4000
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

• 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 EXCLUSION CRITERIA: 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

Related Conditions & MeSH terms

• Screening

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To screen subjects for their eligibility to participate in clinical trials.	Duration of subject participation is variable, and may last from a few weeks to several months for each subject.	Ongoing

External Links

•   NIH Clinical Center Detailed Web Page