Screening Volunteers for Clinical Trials

Purpose

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.

Condition

  • Screening

Eligibility

Eligible Ages
Between 18 Years and 70 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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

Study Design

Phase
Study Type
Observational
Observational Model
Other
Time Perspective
Other

Arm Groups

ArmDescriptionAssigned Intervention
1 Adults 18-70

Recruiting Locations

University of Maryland, Baltimore
Baltimore, Maryland 21201-1595
Contact:
Monica McArthur, Ph.D
410-706-0329
mmcarthu@medicine.umaryland.edu

More Details

NCT ID
NCT01375530
Status
Recruiting
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

Study Contact

Ingelise Gordon, R.N.
(301) 451-8715
vaccines@nih.gov

Detailed Description

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.