Sample Collection From Healthy Volunteers for Assay Optimization

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-28

Study Completion Date

2043-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Send-In Sample Collection for Comprehensive Analyses of Innate and Adaptive Immune Responses During Acute COVID-19 and Convalescence

NCT04582903

COVID-19 Infection

RECRUITING

Recombinant SARS-CoV-2 Fusion Protein Vaccine Booster Immunization Study to Evaluate the Safety and Immunogencity

NCT05239832

COVID-19 Pandemic

UNKNOWN PHASE2

A Study of SI-F019 in Healthy Participants

NCT04851444

Healthy

COMPLETED PHASE1

Clinical Study of SARS-CoV-2 Variant mRNA Vaccine in Healthy Participants

NCT05599802

SARS-CoV-2

UNKNOWN PHASE1

A Trial Investigating the Safety and Effects of One BNT162 Vaccine Against COVID-19 in Healthy Adults

NCT04537949

Covid-19 Protection Against COVID-19

COMPLETED PHASE1/PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Volunteers

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Healthy Volunteers

healthy volunteers

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

3 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes