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Protocol Details

VRC 500: Screening 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 Years
Max Age: 60 Years

Referral Letter Required

No

Population Exclusion(s)

Children

Keywords

Prevention;
Vaccine;
Immunity;
Evaluate;
Screen

Recruitment Keyword(s)

None

Condition(s)

Screening

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. 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.

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Eligibility

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


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

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



VRC Recruitment
National Institute of Allergy and Infectious Diseases (NIAID)

(866) 833-5433
vrcrecruitment@mail.nih.gov

VRC Clinic
National Institute of Allergy and Infectious Diseases (NIAID)
Vaccine Research Center
National Institutes of Health (NIH)
Bethesda, MD 20892

(301) 451-8715
vaccines@nih.gov

Clinical Trials Number:

NCT01375530

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