Sample Collection From Healthy Volunteers for Assay Optimization

Healthy Volunteers Clinical Trial

Official title:

Sample Collection From Healthy Volunteers for Assay Optimization

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03538600
• Other study ID #: 180101
• Secondary ID: 18-I-0101
• Status: Recruiting
• Start date: June 28, 2018
• Est. completion date: June 30, 2027

Study information

• Verified date: May 23, 2024
• Source: National Institutes of Health Clinical Center (CC)
• Contact: Laura E Failla, C.R.N.P.
• Phone: (240) 669-5323
• Email: laura.failla[@]nih.gov
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: June 30, 2027
• Est. primary completion date: June 30, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

• 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.

Related Conditions & MeSH terms

• Healthy Volunteers

Locations

Country	Name	City	State
United States	National Institutes of Health Clinical Center	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.

External Links

•   NIH Clinical Center Detailed Web Page