Screening Volunteers for Clinical Trials

Status:	Recruiting
Healthy:	No
Age Range:	18 - 70
Updated:	3/30/2019
Start Date:	June 16, 2011
Contact:	Ingelise Gordon, R.N.
Email:	vaccines@nih.gov
Phone:	(301) 451-8715

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.

The purpose of this study is to screen potential study subjects to determine if they are
eligible for clinical trials of investigational products conducted by the Vaccine Research
Center (VRC), NIAID, NIH. 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.

- 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

We found this trial at

sites

National Institutes of Health Clinical Center, 9000 Rockville Pike

9000 Rockville Pike
Bethesda, Maryland 20892

Phone: 301-451-8715

from

Bethesda, MD