Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Screening Volunteers for Clinical Trials

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 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: January 21, 2015
Last verified: December 2014

June 16, 2011
January 21, 2015
May 2011
Not Provided
To screen subjects for their eligibility to participate in clinical trials ofinvestigational products or licensed products being evaluated for research purposes. [ Time Frame: Ongoing ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT01375530 on Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
Screening Volunteers for Clinical Trials
VRC 500:Screening of Volunteers for Clinical Trials of Investigational Products and Licensed Products Evaluated for Research Purposes


- 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.

The purpose of this study is to screen potential study volunteers to determine if they are eligible for clinical trials of investigational products conducted by the Vaccine Research Center (VRC), NIAID, NIH at the NIH Clinical Center. Educational materials on the investigational products and protocols will be reviewed with and provided to subjects during

participation in the screening protocol. Approximately 3,000 adults, ages 18-70 years, will be enrolled.

Not Provided
Not Provided
Not Provided
Not Provided
Not Provided
Human Health
Not Provided
Not Provided
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. doi: 10.1038/clpt.2009.128.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Not Provided
Not Provided

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

18 Years to 70 Years
Contact: Ingelise Gordon, R.N. (301) 451-8715
United States
110164, 11-I-0164
Not Provided
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
National Institute of Allergy and Infectious Diseases (NIAID)
Not Provided
Principal Investigator: Julie E Ledgerwood, D.O. National Institute of Allergy and Infectious Diseases (NIAID)
National Institutes of Health Clinical Center (CC)
December 2014

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