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Protocol Details

VRC 500:Screening of Volunteers for Clinical Trials of Investigational Products and Licensed Products Evaluated for Research Purposes

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

11-I-0164

Sponsoring Institute

National Institute of Allergy and Infectious Diseases (NIAID)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18
Max Age: 70

Referral Letter Required

No

Population Exclusion(s)

Children

Special Instructions

Currently Not Provided

Keywords

Prevention;
Vaccine;
Immunity;
Evaluate;
Screen

Recruitment Keyword(s)

Healthy Volunteer;
HV

Condition(s)

Human Volunteers

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Allergy and Infectious Diseases

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.

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Eligibility

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


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Citations:

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.

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Contacts:

Principal Investigator

Referral Contact

For more information:

Julie E. Ledgerwood, D.O.
National Institute of Allergy and Infectious Diseases (NIAID)



Ingelise Gordon, R.N.
National Institute of Allergy and Infectious Diseases (NIAID)
National Institutes of Health
Building 10
Room 12S253
10 Center Drive
Bethesda, Maryland 20892
(301) 451-8715
vaccines@nih.gov

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

prpl@mail.cc.nih.gov

Clinical Trials Number:

NCT01375530

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