Human Immunome Program (HIP)

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: Biospecimen and survey collection

• Study Type: Observational
• Enrollment (Actual): 2

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 49 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Healthy adult volunteers

Description

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).

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Collaborators: Human Vaccines Project
• Investigators: Principal Investigator: James E Crowe Jr., M.D., Vanderbilt University Medical Center

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Actual): June 18, 2020
• Study Completion (Actual): June 18, 2020

Study Registration Dates

• First Submitted: April 13, 2017
• First Submitted That Met QC Criteria: April 13, 2017
• First Posted (Actual): April 18, 2017

Study Record Updates

• Last Update Posted (Actual): February 8, 2021
• Last Update Submitted That Met QC Criteria: February 5, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Immune system
• Other Study ID Numbers: IRB#170398

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No