Collecting samples from healthy volunteers for research

Sample Collection From Healthy Volunteers for Assay Optimization

This study is collecting blood, stool, saliva, and skin samples from healthy volunteers aged 3 to 80 to help improve research tests and track changes in the immune system over time.

Quick facts

• Study type: Observational
• Enrollment: 600 (estimated)
• Ages: 3 Years to 80 Years
• Sex: All
• Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Bethesda, Maryland)
• Trial ID: NCT03538600 on ClinicalTrials.gov

What this trial studies

This study aims to collect biological specimens, including blood, stool, saliva, and skin samples, from healthy volunteers aged 3 to 80 years. The samples will be used to design and improve research tests and to serve as control samples for other studies. Participants will undergo a health screening, including a physical exam and blood tests, to ensure they meet the eligibility criteria. The study also aims to track immunologic changes over time using the developed assays.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy individuals aged 3 to 80 who can provide informed consent.

Not a fit: Patients with a history of autoimmune diseases, diabetes, or recent infections may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the development of research tests that improve our understanding of human biology and disease.

How similar studies have performed: Other studies have successfully utilized similar approaches to collect biological samples for assay development and optimization.

Eligibility criteria

* 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.

Where this trial is running

Bethesda, Maryland

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

Study contacts

• Principal investigator: Kalpana Manthiram, M.D. — National Institute of Allergy and Infectious Diseases (NIAID)
• Study coordinator: Laura E Failla, C.R.N.P.

Conditions Healthy Volunteers; Blood; Microbiome Analysis; Stool; Saliva; Skin; Natural History