Screening Volunteers for Clinical Trials
- The National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health needs healthy volunteers for vaccine clinical trials. These trials will allow researchers to study vaccines and injection devices. These studies will also allow researchers to understand the immune system and how vaccines work. In this protocol, researchers will screen healthy volunteers for these future trials.
- To screen healthy volunteers for clinical trials at the NIAID.
- Healthy people between 18 and 70 years of age. They must be available to take part in clinical trials and be able to provide blood for research studies.
- Screening for a clinical trial may begin several months before the vaccine clinical trial begins.
- Volunteers will be screened with a physical exam and medical history. They may also answer questions about sexual activity and drug use.
- Volunteers will provide blood samples and possibly urine samples. They may have other tests as needed for the study.
- Volunteers will not receive any treatment in this screening trial.
|Study Design:||Time Perspective: Prospective|
|Official Title:||VRC 500:Screening of Volunteers for Clinical Trials of Investigational Products and Licensed Products Evaluated for Research Purposes|
|Study Start Date:||May 2011|
The purpose of this study is to screen potential study volunteers to determine if they are eligible for clinical trials of investigational products. 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 materials on the investigational products and protocols will be reviewed with and provided to subjects during participation in the screening protocol.
To screen subjects for their eligibility to participate in clinical trials of investigational products or licensed products being evaluated for research purposes.
Approximately 3,000 adults; age 18-70 years
Evaluations usually include medical history, physical examination and laboratory tests. Evaluations conducted may be limited to those needed to determine eligibility for the clinical trial(s) for which the subject is being screened and may be expanded to include protocol-specific eligibility assessments or assessments based on investigator judgment to assess the volunteer s health as necessary to determine eligibility for a clinical trial. Blood samples will also be collected and stored for future research.
NIH Clinical Center and other IRB-approved sites.
Duration of Study Participation:
Duration of subject participation is variable, and may last from a few weeks to several months for each subject. Study participation is complete when the subject enrolls in a study of an investigational product, is found to be ineligible for any studies, or declines to participate in any clinical trials.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01375530
|Contact: Ingelise Gordon, R.N.||(301) email@example.com|
|United States, Georgia|
|Hope Clinic - Emory Vaccine Ctr||Recruiting|
|Decatur, Georgia, United States, 30030|
|United States, Maryland|
|University of Maryland, Baltimore||Recruiting|
|Baltimore, Maryland, United States, 21201-1595|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL) 800-411-1222 ext TTY8664111010 firstname.lastname@example.org|
|Principal Investigator:||Julie E Ledgerwood, D.O.||National Institute of Allergy and Infectious Diseases (NIAID)|