Human Immunome Program

NCT03118687 | Completed

• 1 other identifier: IRB#170398
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Immune system

Outcome Measures

Primary Outcomes (1)

• The entire expressed B and T cell receptor repertoire ("Immunome") of the human immune system

  The B and T cell receptor repertoire will be sequenced. The sequencing will continue until no new unique sequences appear.

  10 years

Interventions

Biospecimen and survey collection OTHER

Blood, microbiota, surveys/questionnaires, electronic medical records.

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy adult volunteers

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• Human Vaccines Project: collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Links

• The Human Vaccines Project is the parent project to the Human Immunome Program

Biospecimen

Retention: SAMPLES WITH DNA

* Peripheral blood mononuclear cell (PBMCs) * Microbiome (stool, tongue, skin swabs)(optional)

Study Officials

• James E Crowe Jr., M.D.

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 13, 2017
• First Posted: April 18, 2017
• Study Start: July 1, 2017
• Primary Completion: June 18, 2020
• Study Completion: June 18, 2020
• Last Updated: February 8, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share

Locations

US (1)