NCT03538600 Sample Collection From Healthy Volunteers for Assay Optimization
| NCT ID | NCT03538600 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Institute of Allergy and Infectious Diseases (NIAID) |
| Condition | Healthy Volunteers |
| Study Type | OBSERVATIONAL |
| Enrollment | 600 participants |
| Start Date | 2018-06-28 |
| Primary Completion | 2043-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 600 participants in total. It began in 2018-06-28 with a primary completion date of 2043-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Kalpana Manthiram, M.D.
PRINCIPAL INVESTIGATOR
National Institute of Allergy and Infectious Diseases (NIAID)
Frequently Asked Questions
Who can join the NCT03538600 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, up to 80 Years, studying Healthy Volunteers. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03538600 currently recruiting?
Yes, NCT03538600 is actively recruiting participants. Contact the research team at laura.failla@nih.gov for enrollment information.
Where is the NCT03538600 trial being conducted?
This trial is being conducted at Bethesda, United States.
Who is sponsoring the NCT03538600 clinical trial?
NCT03538600 is sponsored by National Institute of Allergy and Infectious Diseases (NIAID). The principal investigator is Kalpana Manthiram, M.D. at National Institute of Allergy and Infectious Diseases (NIAID). The trial plans to enroll 600 participants.