Sample Collection From Healthy Volunteers for Assay Optimization

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.

• INCLUSION CRITERIA:

• 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.

Exclusion criteria

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.
• Receipt of any other type of vaccine within the past 14 days.
• Current or past use (within the past 90 days) of immunoglobulin therapy.
• Current use of illicit drugs (per subject report).
• Current use of nicotine-containing products, including cigarettes and chewing tobacco, nicotine patches, gum, electronic cigarettes, etc.
• Current alcohol use disorders (criteria per Diagnostic and Statistical Manual of Mental Disorders, fifth edition).
• Any condition that requires active medical intervention or monitoring to avert serious danger to the individual s health or wellbeing.
• 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.