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Trial record 2 of 115 for:    Human Vaccines Project

Human Immunome Program (HIP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03118687
Recruitment Status : Enrolling by invitation
First Posted : April 18, 2017
Last Update Posted : January 9, 2020
Sponsor:
Collaborator:
Human Vaccines Project
Information provided by (Responsible Party):
James E. Crowe, Jr., Vanderbilt University Medical Center

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

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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

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


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)


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03118687


Locations
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United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University Medical Center
Human Vaccines Project
Investigators
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Principal Investigator: James E Crowe Jr., M.D. Vanderbilt University Medical Center
Additional Information:
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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    Key Record Dates
Last Update Posted: January 9, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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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