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Trial record 1 of 4 for:    VRC 500
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Screening Volunteers for Clinical Trials

This study is currently recruiting participants.
See Contacts and Locations
Verified June 12, 2017 by National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
ClinicalTrials.gov Identifier:
NCT01375530
First received: June 16, 2011
Last updated: June 13, 2017
Last verified: June 12, 2017
  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
Human Health

Study Type: Observational
Study Design: Observational Model: Other
Time Perspective: Other
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) ( National Institute of Allergy and Infectious Diseases (NIAID) ):

Primary Outcome Measures:
  • To screen subjects for their eligibility to participate in clinical trials ofinvestigational products or licensed products being evaluated for research purposes. [ Time Frame: Ongoing ]

Estimated Enrollment: 3000
Study Start Date: May 26, 2011
Detailed Description:
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. 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.
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
  • 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

  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 ClinicalTrials.gov identifier: NCT01375530

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

Locations
United States, Georgia
Hope Clinic - Emory Vaccine Ctr Recruiting
Decatur, Georgia, United States, 30030
Contact: Srilatha Edupuganti, M.D.    404-712-1434    sedupug@emory.edu   
United States, Maryland
University of Maryland, Baltimore Recruiting
Baltimore, Maryland, United States, 21201-1595
Contact: Monica McArthur, Ph.D    410-706-0329    mmcarthu@medicine.umaryland.edu   
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: VRC Clinic    301-451-8715    vaccines@nih.gov   
United States, Pennsylvania
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104-6056
Contact: Pablo Tebas    215-349-8092    pablo.tebas@uphs.upenn.edu   
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Principal Investigator: Julie E Ledgerwood, D.O. National Institute of Allergy and Infectious Diseases (NIAID)
  More Information

Additional Information:
Publications:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT01375530     History of Changes
Other Study ID Numbers: 110164
11-I-0164
Study First Received: June 16, 2011
Last Updated: June 13, 2017

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) ):
Prevention
Vaccine
Immunity
Evaluate
Screen
Healthy Volunteer
HV

ClinicalTrials.gov processed this record on June 26, 2017