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Protocol Details

Sample Collection From Healthy Volunteers for Assay Optimization

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

18-I-0101

Sponsoring Institute

National Institute of Allergy and Infectious Diseases (NIAID)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18 Years
Max Age: N/A

Referral Letter Required

No

Population Exclusion(s)

Children

Keywords

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

Recruitment Keyword(s)

None

Condition(s)

Healthy Volunteers

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Allergy and Infectious Diseases

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.

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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.


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Rachel D. Sparks, M.D.
National Institute of Allergy and Infectious Diseases (NIAID)
NIHBC 04 BG RM 138
4 MEMORIAL DR
BETHESDA MD 20892
(240) 292-4642
rachel.sparks@nih.gov

Laura E. Failla, C.R.N.P.
National Institute of Allergy and Infectious Diseases (NIAID)
NIHBC 04 BG RM 134
4 MEMORIAL DR
BETHESDA MD 20892
(240) 669-5323
laura.failla@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT03538600

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