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Screening for LID Clinical Studies Unit Healthy Volunteer Protocols

NCT01386424 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 5000

Last updated 2026-05-22

No results posted yet for this study

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.

Conditions

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Matthew J Memoli, M.D. · National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-07-20

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01386424 on ClinicalTrials.gov