Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Trial record 1 of 1 for:    VRC 500
Previous Study | Return to List | Next Study

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)
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) ) Identifier:
First received: June 16, 2011
Last updated: November 11, 2014
Last verified: January 2014


- 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.

Human Volunteers

Study Type: Observational
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

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 3000
Study Start Date: May 2011
Detailed Description:

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 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.


Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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


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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01375530

Contact: Ingelise Gordon, R.N. (301) 451-8715

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   
Sponsors and Collaborators
Principal Investigator: Julie E Ledgerwood, D.O. National Institute of Allergy and Infectious Diseases (NIAID)
  More Information

Additional Information:
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) ) Identifier: NCT01375530     History of Changes
Other Study ID Numbers: 110164, 11-I-0164
Study First Received: June 16, 2011
Last Updated: November 11, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Healthy Volunteer
HV processed this record on November 24, 2014