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Sample Collection From Healthy Volunteers for Assay Optimization

National Institute of Allergy and Infectious Diseases (NIAID) · NCT03538600

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 3–80 · All sexes
Healthy volunteers
Accepted
Study type
Observational
Target enrollment
600
US sites recruiting
1
Study start
June 28, 2018
Record last updated
October 21, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Conditions: Healthy Volunteers

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria
  • INCLUSION CRITERIA:
  • Aged 3-80 years.
  • Able to provide informed consent (for ages >=18 years) or has a parent or guardian who can provide informed consent on their behalf (for ages \<18 years).
  • Agree to allow biological samples to be stored for future research.
  • Willing to provide blood, stool, saliva, skin/mucosal/tonsil swabs, and/or skin punch biopsy specimens.

EXCLUSION CRITERIA

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.

Recruiting US locations

  • National Institutes of Health Clinical Center

    Bethesda, MD 20892

    Site contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) · 800-411-1222 · prpl@cc.nih.gov

Study contacts (from the official record)

  • Laura E Failla, C.R.N.P. · (240) 669-5323 · laura.failla@nih.gov
  • Kalpana Manthiram, M.D. · (301) 529-4787 · kalpana.manthiram@nih.gov
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Sample Collection From Healthy Volunteers for Assay Optimization (NCT03538600) | Bored Studies