Sample Collection From Healthy Volunteers for Assay Optimization

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 18-80

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy Volunteers

Detailed Description

The Laboratory of Immune System Biology plays a major role in fostering the growth of systems biology efforts across the National Institutes of Health, in large measure through its development of new tools for high-throughput data generation and complex systems modeling. The lab s experimental component requires ongoing assay development and optimization, which depend on the availability of human biological samples for testing. The primary purpose of this protocol is to obtain biological specimens from healthy volunteers to support the lab s development and optimization of scientific assays, and to use as control samples for research tests in other studies. The secondary objective of this study is to track immunologic changes over time using the assays developed and optimized in this study.

• Study Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

• Study Contact: Name: Kalpana Manthiram, M.D.; Phone Number: (301) 529-4787; Email: kalpana.manthiram@nih.gov
• Study Contact Backup: Name: Laura E Failla, C.R.N.P.; Phone Number: (240) 669-5323; Email: laura.failla@nih.gov

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20892
      • Recruiting
      • National Institutes of Health Clinical Center
      • Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR); Phone Number: TTY8664111010 800-411-1222; Email: prpl@cc.nih.gov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Healthy Adult Volunteers between the ages of 18-80.

Description

• INCLUSION CRITERIA:

  1. Age 18-80 years.
  2. Able to provide informed consent.
  3. Agree to allow biological samples to be stored for future research.
  4. Willing to provide blood, stool, saliva, skin/mucosal swabs and/or skin punch biopsy specimens.

EXCLUSION CRITERIA:

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 parasitic, amebic, fungal or mycobacterial infections within the past 5 years.
9. Infected with HIV and/or hepatitis B and/or C.
10. Use of an oral glucocorticoid within the past 30 days.
11. History of a bleeding disorder.
12. Complete blood count with differential and/or acute care panel values are both outside of the NIH Department of Laboratory Medicine normal reference range and deemed clinically significant by the principal investigator (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.

Co-enrollment guidelines: Participants may be co-enrolled in other studies with the approval of the PI.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Healthy Volunteers; healthy volunteers

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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...	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 tests in other studies.. There is no specified outcome.	Throughout the study.

Collaborators and Investigators

• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Investigators: Principal Investigator: Kalpana Manthiram, M.D., National Institute of Allergy and Infectious Diseases (NIAID)

Publications and helpful links

Helpful Links

• NIH Clinical Center Detailed Web Page

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2018
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: May 25, 2018
• First Submitted That Met QC Criteria: May 25, 2018
• First Posted (Actual): May 29, 2018

Study Record Updates

• Last Update Posted (Estimated): April 30, 2024
• Last Update Submitted That Met QC Criteria: April 27, 2024
• Last Verified: April 25, 2024

More Information

Terms related to this study

• Keywords: Natural History; Skin; Blood; Saliva; Stool; Microbiome Analysis
• Other Study ID Numbers: 180101; 18-I-0101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No