Sample Collection From Healthy Volunteers for Assay Optimization

Recruiting now

Conditions studied: Healthy Volunteers

In brief

Background: The Laboratory of Immune System Biology (LISB) works with other labs at the National Institutes of Health. They study how parts of living things come together to make a whole. LISB designs and improves research tests on human samples like blood and cells. In order to do its work, LISB needs to have a lot of these samples available. Objective: To collect biological specimens to use for designing and improving research tests. Specimens include blood, stool, saliva, and skin/mucosal swabs. Eligibility: Healthy people ages 3-80 Design: Participants will be screened with an interview about their general health and their medical history. They will have a physical exam and blood tests. If the results of the screening are normal, participants will be asked to give one or more of these samples: Blood will be drawn from an arm vein with a needle and syringe. Mucus and skin will be collected by rubbing the area with a cotton swab. The areas may include the top of the tongue, inside the cheek, nostrils, behind the ear, elbow pit, or vagina. Participants will spit into a tube to collect saliva. Participants will pass stool into a plastic container that fits in the toilet under the seat. They will get sampling kits and instructions. Over the next 5 years, if more samples are needed, participants will be contacted to set up another visit to the NIH. These visits will each take about 1 hour. About every 2 years, when participants come to NIH for a visit, extra blood will be collected. It will be tested for HIV and hepatitis B and C. ...

Key facts

Study ID

NCT03538600

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

600

Starts

2018-06-28

Expected to finish

2043-06-30

Last updated by the study team

2026-08-07

Who can join

Age: 3 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• Individuals meeting any of the following criteria will be excluded from study participation:
• Pregnancy.
• History of autoimmune or autoinflammatory disease.
• Diabetes mellitus.
• Cancer chemotherapy within the past 5 years.
• Currently receiving treatment for an active malignancy.
• Surgery within the past 8 weeks.
• History of recent (within the past 30 days) infection.
• History of significant, active parasitic, amebic, fungal, or mycobacterial infections within the past 5 years (as determined by the PI).
• Infected with HIV and/or hepatitis B and/or C.
• Use of an oral or inhaled glucocorticoid within the past 30 days.
• History of a bleeding disorder.
• Screening lab values are both outside of the NIH Department of Laboratory Medicine normal reference range and deemed clinically significant by the PI.
• Receipt of an immunosuppressant or immunomodulatory drug within the past 30 days.
• Receipt of a live-attenuated vaccine within the past 30 days.
• Receipt of any other type of vaccine within the past 14 days.
• Current or past use (within the past 90 days) of immunoglobulin therapy.
• Current use of illicit drugs (per subject report).
• Current use of nicotine-containing products, including cigarettes and chewing tobacco, nicotine patches, gum, electronic cigarettes, etc.
• Current alcohol use disorders (criteria per Diagnostic and Statistical Manual of Mental Disorders, fifth edition).
• Any condition that requires active medical intervention or monitoring to avert serious danger to the individual s health or wellbeing.
• Any condition that, in the opinion of the PI, contraindicates participation in this study or would significantly affect immune profile.
• Co-enrollment guidelines: Participants may be co-enrolled in other studies. The PI may withdraw them from this study for any reason that may contraindicate participation.

Where it is running

• National Institutes of Health Clinical Center — Bethesda, Maryland, United States (enrolling)

Full record on ClinicalTrials.gov

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