RecruitingNCT01386424

Screening for LID Clinical Studies Unit Healthy Volunteer Protocols


Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Enrollment

5,000 participants

Start Date

Jul 20, 2011

Study Type

OBSERVATIONAL

Conditions

Summary

Background: * The Laboratory of Infectious Diseases (LID) Clinical Studies Unit (CSU) enrolls healthy volunteers into clinical studies to study infectious diseases. * Viruses can be highly infectious and contagious. They cause considerable illness in the United States each year and a good example of this is influenza (the flu). The LID CSU performs clinical studies to learn about these viral infections and assist in the development of vaccines and treatments for the infections. These clinical studies include influenza "challenge studies" as well as natural history studies and phase I trials involving vaccines for viruses carried by mosquitos such as Zika or Dengue virus. * In influenza challenge studies studies, doctors expose a person to a flu virus. Then they study the flu through the body's natural healing process. This information will help to find better ways to prevent the flu and may also improve treatments for the flu. * Natural history studies and phase I trials of new vaccines are performed so the researchers can learn how some viral infections occur and if new vaccines are safe and potentially effective in preventing the infections. In some of these studies, participants experience insect bites with special clean (non-infected) insects (such as mosquitos) to better understand the role of insects in these infections. Objectives: \- To screen healthy volunteers for future CSU studies. Eligibility: \- Healthy people between the ages of 18 and 65 Design: * The 3- to 5-hour screening exam includes the following: * Medical history and physical exam * Standard blood tests including pregnancy, Hepatitis B and C, and HIV tests * Standard urine drug testing * Electrocardiogram (ECG) to test heart rhythm and function * Chest x-ray * Eligible volunteers are enrolled in the study for up to 1 year, until they take part in a CSU study or are found to be ineligible to participate. * Volunteers may withdraw from the study pool at any time.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This is a screening study for healthy volunteers at the NIH Laboratory of Infectious Diseases (LID) Clinical Studies Unit. Participants who qualify may be invited to join future vaccine or infectious disease research studies. You may be eligible if: - You are between 18 and 65 years of age with no significant health problems - You are willing to consider taking part in a future healthy volunteer study - You are not of childbearing potential, OR you agree to use effective contraception or abstain from sex for at least 4 weeks before and during any future specific study - You are willing to have samples stored for future research You may NOT be eligible if: - You have a significant medical condition such as chronic lung disease, heart disease, diabetes, kidney problems, cancer, or neurological conditions - You have a history of drug or alcohol dependency or abuse - You have any condition that the investigator believes would put you at risk or prevent you from giving informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

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NCT01386424


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