Sample Collection From Healthy Volunteers for Assay Optimization

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
Overall Status
Recruiting
CT.gov ID
NCT03538600
Collaborator
(none)
600
Enrollment
1
Location
108.1
Anticipated Duration (Months)
5.6
Patients Per Site Per Month

Study Details

Study Description

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 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.

Condition or DiseaseIntervention/TreatmentPhase

    Detailed 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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    600 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Sample Collection From Healthy Volunteers for Assay Optimization
    Actual Study Start Date :
    Jun 28, 2018
    Anticipated Primary Completion Date :
    Jun 30, 2027
    Anticipated Study Completion Date :
    Jun 30, 2027

    Arms and Interventions

    ArmIntervention/Treatment
    Healthy Volunteers

    healthy volunteers

    Outcome Measures

    Primary Outcome Measures

    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... [Throughout the study.]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    • 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.

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1National Institutes of Health Clinical CenterBethesdaMarylandUnited States20892

    Sponsors and Collaborators

    • National Institute of Allergy and Infectious Diseases (NIAID)

    Investigators

    • Principal Investigator: Rachel D Sparks, M.D., National Institute of Allergy and Infectious Diseases (NIAID)

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    National Institute of Allergy and Infectious Diseases (NIAID)
    ClinicalTrials.gov Identifier:
    NCT03538600
    Other Study ID Numbers:
    • 180101
    • 18-I-0101
    First Posted:
    May 29, 2018
    Last Update Posted:
    Dec 1, 2021
    Last Verified:
    Nov 29, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID)

    Study Results

    No Results Posted as of Dec 1, 2021