Screening Volunteers for Clinical Trials

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01375530
First received: June 16, 2011
Last updated: March 14, 2014
Last verified: January 2014

June 16, 2011
March 14, 2014
May 2011
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Complete list of historical versions of study NCT01375530 on ClinicalTrials.gov Archive Site
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Screening Volunteers for Clinical Trials
VRC 500:Screening of Volunteers for Clinical Trials of Investigational Products and Licensed Products Evaluated for Research Purposes

Background:

- 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.

Objectives:

- To screen healthy volunteers for clinical trials at the NIAID.

Eligibility:

- 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.

Design:

  • 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:

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.

Primary Objective:

To screen subjects for their eligibility to participate in clinical trials of investigational products or licensed products being evaluated for research purposes.

Subjects Study:

Approximately 3,000 adults; age 18-70 years

Evaluations:

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.

Clinical Sites:

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.

Observational
Time Perspective: Prospective
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Human Volunteers
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Graham BS, Ledgerwood JE, Nabel GJ. Vaccine development in the twenty-first century: changing paradigms for elusive viruses. Clin Pharmacol Ther. 2009 Sep;86(3):234-6. No abstract available.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
3000
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  • INCLUSION CRITERIA:

Age: 18-70 years of age

Available to participate for the planned duration of the clinical trial for which the screening is being done

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

Both
18 Years to 70 Years
Yes
Contact: Ingelise Gordon, R.N. (301) 451-8715 vaccines@nih.gov
United States
 
NCT01375530
110164, 11-I-0164
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National Institute of Allergy and Infectious Diseases (NIAID)
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Principal Investigator: Julie E Ledgerwood, D.O. National Institute of Allergy and Infectious Diseases (NIAID)
National Institutes of Health Clinical Center (CC)
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP