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Protocol Details

Screening of Volunteers for Clinical Trials of Investigational or Licensed Vaccines or Antiviral Products

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts




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: 120

Referral Letter Required


Population Exclusion(s)



Licensed Vaccines;
Blood Draw;
Investigational Vaccines;
Healthy Volunteers;
Eligibility Screening

Recruitment Keyword(s)



Antiviral Agents;
Immunologic Factors;
Physiological Effects of Drugs;
Anti-Infective Agents

Investigational Drug(s)


Investigational Device(s)




Supporting Site

National Institute of Allergy and Infectious Diseases


- Vaccines and antiviral therapies help prevent and treat diseases. Researchers need a group of healthy volunteers for clinical trials. Clinical trials are studies that test these vaccines and therapies in people.


- To screen volunteers for clinical trials for investigational or licensed vaccines or drugs to treat or prevent virus infections.


- Healthy adults age 18 or older.


- Participants will be asked questions about their health history, including sexual activity and drug use. They will give blood samples. They may have a physical exam. They may give a urine sample.

- Participants may have the inside of their nose either swabbed or washed with some fluid. The fluid will be collected. They may give a stool sample.

- Participants may have an electrocardiogram. Soft, sticky patches will be attached to participants chest, arms, and legs. They will lie still on a table while the patches detect the heart s electrical signals. A machine will record these signals.

- Participants may have lung function tests. These tests measure the volume of air moving in and out of the lungs. Participants will forcibly blow air into a machine.

- Participants will be told if any tests show a medical problem.

- If a participant is eligible and decides to join an investigational clinical trial, researchers will explain the study and the risks involved. Participants will sign a separate consent for that clinical trial.

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-Age: 18 or older

-Available to participate for the planned duration of at least one clinical trial for which screening is being done or to donate blood, nasal swab, throat swab, and/or urine in support of assay development

-Able and willing to complete the informed consent process

-Agree to have blood and/or urine, stool, nasal swab, or wash samples collected as needed for the clinical trial screening or sample donation process

-Agree to participate in procedures, such as electrocardiogram or pulmonary function tests, as may be needed for the clinical trial screening process

-Do not have plans to become pregnant while on this study

- Able to provide a medical history and other relevant personal information as appropriate


-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

-If planning to enroll in a clinical trial, the receipt of immunoglobulin within the past 6 months or anticipated within the next year

-Any other condition that in the opinion of the investigator would make the subject unsuitable for enrollment or could interfere with the subject participating in and completing the study or a specimen donation.

-Use of recreational drugs or alcohol dependency or abuse

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Not Provided

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Principal Investigator

Referral Contact

For more information:

Richard T. Davey Jr., M.D.
National Institute of Allergy and Infectious Diseases (NIAID)
NIHBC 10 - CRC BG RM 4-1479NE
(301) 496-8029

Jocelyn Voell, R.N.
National Institute of Allergy and Infectious Diseases (NIAID)
National Institutes of Health
Building 10
Room 8C406
10 Center Drive
Bethesda, Maryland 20892
(301) 435-7913

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1

Clinical Trials Number:


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