Recruiting

Biological Specimens

Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Code:

NCT03538600

Conditions

Healthy Volunteers

Eligibility Criteria

Sex: All

Age: 3 - 70+

Healthy Volunteers: Accepted

Study Details

Brief summary:

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

Study ID

NCT03538600

Start date

Jun 28, 2018

Status verified date

Sep 4, 2026

Completion date

Jun 30, 2043

Anticipated

Primary completion date

Jun 30, 2043

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3 - 70+

Healthy Volunteers: Accepted

  • INCLUSION CRITERIA:

1. Aged 3-80 years.
2. 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).
3. Agree to allow biological samples to be stored for future research.
4. 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:

1. Pregnancy.
2. History of autoimmune or autoinflammatory disease.
3. Diabetes mellitus.
4. Cancer chemotherapy within the past 5 years.
5. Currently receiving treatment for an active malignancy.
6. Surgery within the past 8 weeks.
7. History of recent (within the past 30 days) infection.
8. History of significant, active parasitic, amebic, fungal, or mycobacterial infections within the past 5 years (as determined by the PI).
9. Infected with HIV and/or hepatitis B and/or C.
10. Use of an oral or inhaled glucocorticoid within the past 30 days.
11. History of a bleeding disorder.
12. Screening lab values are both outside of the NIH Department of Laboratory Medicine normal reference range and deemed clinically significant by the PI.
13. Receipt of an immunosuppressant or immunomodulatory drug within the past 30 days.
14. Receipt of a live-attenuated vaccine within the past 30 days.
15. Receipt of any other type of vaccine within the past 14 days.
16. Current or past use (within the past 90 days) of immunoglobulin therapy.
17. Current use of illicit drugs (per subject report).
18. Current use of nicotine-containing products, including cigarettes and chewing tobacco, nicotine patches, gum, electronic cigarettes, etc.
19. Current alcohol use disorders (criteria per Diagnostic and Statistical Manual of Mental Disorders, fifth edition).
20. Any condition that requires active medical intervention or monitoring to avert serious danger to the individual s health or wellbeing.
21. 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.

Study Design

Enrollment

600 participants

Anticipated

Interventions and Outcome Measures

Arms

Healthy Volunteers

healthy volunteers

Primary outcome measure

  • The purpose of this study is to collect biological specimens (blood, stool, saliva, skin/mucosal swabs, and/or skin punch biopsy specimens) for the development and optimization of scientific assays, and to use as control samples for research tes... [ Time Frame: Throughout the study. ]

Central Contacts and Locations

Central contacts

Laura E Failla, C.R.N.P.

(240) 669-5323laura.failla@nih.gov

Kalpana Manthiram, M.D.

(301) 529-4787kalpana.manthiram@nih.gov

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)

800-411-1222prpl@cc.nih.gov

More Information

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Last update posted

Sep 9, 2026

Last verified

Sep 4, 2026

Keywords

  • Blood
  • Microbiome Analysis
  • Stool
  • Saliva
  • Skin
  • Natural History

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Institute of Allergy and Infectious Diseases (NIAID) on 2026-09-09.