Sample Collection From Healthy Volunteers for Assay Optimization
2 other identifiers
observational
600
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2018
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 25, 2018
CompletedFirst Posted
Study publicly available on registry
May 29, 2018
CompletedStudy Start
First participant enrolled
June 28, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2043
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2043
April 24, 2026
March 3, 2026
25 years
May 25, 2018
April 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Study Arms (1)
Healthy Volunteers
healthy volunteers
Eligibility Criteria
Healthy Volunteers between the ages of 3-80.
You may qualify if:
- Aged 3-80 years.
- 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).
- Agree to allow biological samples to be stored for future research.
- Willing to provide blood, stool, saliva, skin/mucosal/tonsil swabs, and/or skin punch biopsy specimens.
You may not qualify if:
- Individuals meeting any of the following criteria will be excluded from study participation:
- Pregnancy.
- History of autoimmune or autoinflammatory disease.
- Diabetes mellitus.
- Cancer chemotherapy within the past 5 years.
- Currently receiving treatment for an active malignancy.
- Surgery within the past 8 weeks.
- History of recent (within the past 30 days) infection.
- History of significant, active parasitic, amebic, fungal, or mycobacterial infections within the past 5 years (as determined by the PI).
- Infected with HIV and/or hepatitis B and/or C.
- Use of an oral or inhaled glucocorticoid within the past 30 days.
- History of a bleeding disorder.
- Screening lab values are both outside of the NIH Department of Laboratory Medicine normal reference range and deemed clinically significant by the PI.
- Receipt of an immunosuppressant or immunomodulatory drug within the past 30 days.
- Receipt of a live-attenuated vaccine within the past 30 days.
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
Related Links
Study Officials
- PRINCIPAL INVESTIGATOR
Kalpana Manthiram, M.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 25, 2018
First Posted
May 29, 2018
Study Start
June 28, 2018
Primary Completion (Estimated)
June 30, 2043
Study Completion (Estimated)
June 30, 2043
Last Updated
April 24, 2026
Record last verified: 2026-03-03