Screening Volunteers for Clinical Trials

August 29, 2026 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

VRC 500: Screening 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. This is a screening study that is used to identify healthy volunteers who may be eligible to participate in other clinical trials at the Vaccine Research Center that evaluate investigational vaccines, monoclonal antibodies, and injection devices. The VRC conducts studies that will allow researchers to better understand the immune system and how vaccines and monoclonal antibodies work.

Objectives:

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

Eligibility:

- Healthy people between 18 and 60 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 healthy volunteers to participate in clinical trials is an ongoing process.
Volunteers will be asked about their medical history, including sexual activity and drug use, and a detailed physical exam will be performed.
Blood and urine samples may be collected, and possibly other tests as needed to evaluate the volunteer's health status.
Volunteers will not receive any investigational product in this screening protocol....

Study Overview

Status

Recruiting

Conditions

Screening

Detailed Description

The purpose of this study is to recruit and screen potential study subjects, mostly healthy volunteers, to determine if they are eligible for clinical trials of investigational products. This screening study also aims to characterize and analyze demographic information as well as laboratory and other medical findings in terms of how they may affect the eligibility of subjects for specific early phase clinical trials. 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 and recruitment materials on the investigational products and protocols will be

reviewed with and provided to subjects during participation in the screening protocol.

Study Type

Observational

Enrollment (Estimated)

4000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: VRC Recruitment
Phone Number: (866) 833-5433
Email: vrcrecruitment@mail.nih.gov

Study Locations

United States
- Georgia
  - Atlanta, Georgia, United States, 30030
    - Completed
    - Emory University
- Maryland
  - Baltimore, Maryland, United States, 21201-1595
    - Active, not recruiting
    - Univ of MD School of Medicine Center for Vaccine Development & Global Health
  - Bethesda, Maryland, United States, 20892
    - Recruiting
    - National Institutes of Health Clinical Center
    - Contact:
      
      VRC Clinic
      
      Phone Number: 301-451-8715
      
      Email: vaccines@nih.gov
- Pennsylvania
  - Philadelphia, Pennsylvania, United States, 19104-6056
    - Completed
    - University of Pennsylvania-UPenn

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Healthy volunteers

Description

INCLUSION CRITERIA:

Age: 18 years of age or older

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Other
Time Perspectives: Other

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
1 Healthy adults 18 - 60 years old

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To screen subjects for their eligibility to participate in clinical trials. Time Frame: Ongoing	Duration of subject participation is variable, and may last from a few weeks to several months for each subject.	Ongoing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

Principal Investigator: Lasonji A Holman, C.R.N.P., National Institute of Allergy and Infectious Diseases (NIAID)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

NIH Clinical Center Detailed Web Page

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 16, 2011

Study Registration Dates

First Submitted

June 16, 2011

First Submitted That Met QC Criteria