Screening for LID Clinical Studies Unit Healthy Volunteer Protocols

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type

Observational

Phase

Not applicable / not listed

Age range

18 years - 65 years

Sex eligible

All sexes

Healthy volunteers

Accepted

Participants

5000 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

• INCLUSION CRITERIA:

1. Greater than or equal to 18 and less than or equal to 65 years old, and have no significant health abnormalities
2. Willing to consider taking part in a future LID Clinical Studies Unit healthy volunteer study
3. A female participant is eligible for this study if she is any of the following:
* Of non-childbearing potential (i.e., women who have had a hysterectomy or tubal ligation or are post-menopausal, as defined by no menses in greater than or equal to 1 year)
* Of childbearing potential but agrees to practice effective contraception or abstinence (from heterosexual sex) for 4 weeks prior to enrolling into a spceific study and during the study.

NOTE: Acceptable methods of contraception may include one or more of the following: 1) male partner who is sterile prior to the female participant's entry into the study and is the sole sexual partner for the female participant; 2) implants of levonorgestrel; 3) injectable progestogen;, 4) an intrauterine device with a documented failure rate of less than 1percent; 5) oral contraceptives; or 6) double barrier methods including diaphragm or condom with a spermicide.

4\. Willing to have samples stored for future research

EXCLUSION CRITERIA:

1. Self-reported history of any significant medical condition including but not limited to:

* Chronic pulmonary disease (such as asthma, emphysema)
* Chronic cardiovascular disease (cardiomyopathy, congestive heart failure, cardiac surgery, ischemic heart disease, known anatomic defects)
* Chronic medical conditions requiring close medical follow-up or hospitalization during the past 5 years (diabetes mellitus, renal dysfunction, hemoglobinopathies)
* Immunosuppression or cancer
* Neurological and neuro-developmental conditions (e.g., cerebral palsy, epilepsy, stroke, seizures)
* Drug and/or alcohol dependency and/or abuse
2. Any condition that, in the judgment of the Principal Investigator, is a contraindication to protocol participation or impairs the volunteer s ability to give informed consent

Study population

General Population

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Not reported

Masking

Not reported

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Research locations (1)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

1 locations

Study team and timeline

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Study start

Jul 20, 2011 Actual

Primary completion

Not reported

Study completion

Not reported

First posted

Jul 1, 2011 Estimated

Last updated

Nov 10, 2026 Actual

Official study contacts