Clinical trial NCT03118687: Human Immunome Program
Official title: Human Immunome Program
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: Immune system
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: Human Vaccines Project
First posted: 2017-04-18
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy adult volunteers

Brief summary: The Human Immunome Program is a large-scale, open-source effort seeking to fill a major gap in our knowledge of the immune system. The power of the immune system to fight disease lies in its ability recognize and adapt to an astonishing range of threats from viruses, parasites and bacteria to cancer cells. Underlying this ability is a vast but specific set of genes and molecular structures known as the human immunome, or the "parts list" of the immune system. This study aims to decipher the genetic sequences that make up this part list and link it to information about a person's microbiome composition and characteristics such as health history, race, and demographics over time. This information, made freely available to the public for use in research in de-identified form, will allow investigators to answer a wide variety of different questions about immune system function. This could transform how we diagnose, prevent and treat disease though the identification of new biomarkers while enabling highly targeted, computationally designed vaccines and therapies that reduce time and risk of product development.


Eligibility criteria: Inclusion Criteria:

* Healthy male and female volunteers between the ages of 18 - 49 years of age at the time of first enrollment.
* Ability to comply: Participant willing and able to comply with the requirements of the protocol.
* Consent: Participants who have given informed consent for participation in the study

Exclusion Criteria:

Reason for exclusion throughout the entire study period:

* History of severe anemia requiring blood transfusion or current Hemoglobin \< 10g/dL.
* Currently pregnant or pregnancy within 6 months.
* Current participation in another study resulting in blood collection which exceeds 550 ml in an 8 week period or occurs more frequently than 2 times per week.
* Temperature \>101.4F
* Any condition which, in the opinion of the investigator, might interfere with study objectives.
* Any reason which, in the opinion of the investigator, adds additional risk to the patient.

Reason for exclusion in year 0 but not in year 1-9:

* History of known HIV infection or treatment.
* Immunosuppressive disease or use of systemic immunosuppressive therapy using drugs or cytotoxic agents including prednisone (IV, oral or inhaled) less than 6 months ago.
* History of diabetes mellitus -or a glucose (on CMP) ≥200 mg/dL.
* History of cancer including skin cancer.
* History of autoimmune disorders including but not limited to: Ulcerative colitis, Crohn's, Inflammatory Bowel Disease, Rheumatoid Arthritis, Scleroderma, Systemic lupus Erythematosus, Mixed Connective Tissue Disease, Graves, Autoimmune Thyroiditis, Hashimoto's Thyroiditis, Psoriasis, Multiple Sclerosis, Guillain-Barre Syndrome, Chronic Inflammatory demyelinating polyneuropathy, Myasthenia Gravis, Vasculitis, Alopecia areata, autoimmune hemolytic anemia, autoimmune hepatitis, dermatomyositis, idiopathic thrombocytopenic purpura, pemphigus, pernicious anemia, polyarteritis nodosa, polymyositis, Sjogren's Syndrome, Wegener's
* Severe obesity = (BMI \>40 kg/m2).

Primary outcomes:
measure: The entire expressed B and T cell receptor repertoire ("Immunome") of the human immune system
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: James E Crowe Jr., M.D.
role: PRINCIPAL_INVESTIGATOR
References: