Human Immunome Program (HIP)

• ClinicalTrials.gov Identifier: NCT03118687
• Recruitment Status: Enrolling by invitation
• First Posted: April 18, 2017
• Last Update Posted: January 9, 2020
• Sponsor: Vanderbilt University Medical Center
• Collaborator: Human Vaccines Project
• Information provided by (Responsible Party): James E. Crowe, Jr., Vanderbilt University Medical Center

Study Description

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.

Condition or disease	Intervention/treatment
Healthy	Other: Biospecimen and survey collection

Study Design

• Study Type: Observational
• Actual Enrollment: 2 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Human Immunome Program
• Actual Study Start Date: July 1, 2017
• Estimated Primary Completion Date: February 28, 2028
• Estimated Study Completion Date: April 30, 2028

Groups and Cohorts

Intervention Details:

• Other: Biospecimen and survey collection
  Blood, microbiota, surveys/questionnaires, electronic medical records.

Outcome Measures

Primary Outcome Measures :

1. The entire expressed B and T cell receptor repertoire ("Immunome") of the human immune system [ Time Frame: 10 years ]
   The B and T cell receptor repertoire will be sequenced. The sequencing will continue until no new unique sequences appear.

Biospecimen Retention:   Samples With DNA

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 49 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Non-Probability Sample

Study Population

Healthy adult volunteers

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).

Contacts and Locations

Locations

United States, Tennessee

Vanderbilt University Medical Center

Nashville, Tennessee, United States, 37232

Sponsors and Collaborators

Vanderbilt University Medical Center

Human Vaccines Project

Investigators

• Principal Investigator: James E Crowe Jr., M.D.; Vanderbilt University Medical Center

More Information

Additional Information:

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

• Responsible Party: James E. Crowe, Jr., Principal Investigator, Vanderbilt University Medical Center
• ClinicalTrials.gov Identifier: NCT03118687
• Other Study ID Numbers: IRB#170398
• First Posted: April 18, 2017
• Last Update Posted: January 9, 2020
• Last Verified: January 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by James E. Crowe, Jr., Vanderbilt University Medical Center:

Immune system