Sample Collection From Healthy Volunteers for Assay Optimization

Description

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.

Conditions

Healthy Volunteers

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Study Overview

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Study Details

Study overview

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.

Sample Collection From Healthy Volunteers for Assay Optimization

Sample Collection From Healthy Volunteers for Assay Optimization

Condition
Healthy Volunteers
Intervention / Treatment

-

Contacts and Locations

Bethesda

National Institutes of Health Clinical Center, Bethesda, Maryland, United States, 20892

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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. 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 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.

Ages Eligible for Study

3 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

National Institute of Allergy and Infectious Diseases (NIAID),

Kalpana Manthiram, M.D., PRINCIPAL_INVESTIGATOR, National Institute of Allergy and Infectious Diseases (NIAID)

Study Record Dates

2043-06-30