Effects of Systemically Administered Hydrocortisone on the Immune System in Healthy Volunteers
Condition: Immunosuppression; Healthy; Healthy Subjects
Study type: Observational

Summary: 
      Background:

      - Corticosteroids have been used to treat inflammation and immune system diseases for
      decades. However, despite their widespread use, there is little information on the specifics
      of how corticosteroids affect the immune system in humans. The Center for Human Immunology,
      Autoimmunity, and Inflammatory Diseases is interested in studying how the steroid hormone
      hydrocortisone affects the immune system in healthy volunteers, and in doing so to understand
      how hydrocortisone given at different doses works in treating many immune and inflammatory
      conditions.

      Objectives:

      - To evaluate the effects of hydrocortisone on the immune and inflammatory responses of
      healthy volunteers over the short and intermediate term (up to 28 days after administration).

      Eligibility:

      - Healthy volunteers at least 18 years of age.

      Design:

        -  Participants will be screened with a full medical history and physical examination, and
           blood and urine tests. At this visit, participants will be separated into two groups,
           with each group scheduled to receive a different amount of hydrocortisone during the
           study visit.

        -  One week before the study visit, participants will provide a blood sample for baseline
           testing.

        -  Participants will be admitted for a 24-hour inpatient stay that will involve frequent
           blood draws. Between blood draws, participants will be able to work, watch TV, walk
           around, and so on, and will be provided with regular meals.

        -  Blood will be drawn 1 hour before the infusion of hydrocortisone. Participants will be
           divided into two further sets of groups with different blood draw schedules:

        -  Groups 1 (lower dose) and 2 (higher dose) will have blood draws 1, 4, 8, 12, and 24
           hours after the hydrocortisone infusion.

        -  Groups 3 (lower dose) and 4 (higher dose) will have multiple blood draws over 24 hours,
           with timing based on data from the previous groups blood test results.

        -  Participants will provide additional blood samples 7 and 28 days after the in-patient
           visit....
    

Detailed description: 
      Corticosteroids have been in widespread therapeutic use as anti-inflammatory and
      immunomodulatory agents for decades, and there is a wealth of information on their
      immunosuppressive effects in animals and in human cells cultured in vitro. However, despite
      their ubiquitous clinical use, there is a paucity of information on the effects of
      corticosteroids administered to humans systemically, and no previous study has examined their
      effects on the human immunome.

      Therefore the Center for Human Immunology, Autoimmunity, and Inflammatory Diseases proposes
      this protocol designed to obtain blood from healthy adult subjects at baseline, and then at
      various time points after administration of 250 mg and 50 mg of intravenous hydrocortisone.
      These samples will be used to perform a comprehensive and detailed analysis of the immune
      system in response to corticosteroid administration. To our knowledge, this protocol will be
      the first study to characterize the human cellular and molecular immune system parameters, or
      immunome, in healthy adult subjects after administration of corticosteroids. This information
      may be useful in understanding the mechanistic effects of this commonly prescribed class of
      medications in humans.

      The primary objective is to perform laboratory studies to characterize the immune response in
      healthy adult volunteers after administration of moderate (250 mg) and low (50 mg) doses of
      the glucocorticoid hydrocortisone. Primary endpoint is the results of the research laboratory
      assessments. As samples will be stored indefinitely, the time frame for primary endpoint is
      indefinite.
    

Time perspective: Prospective
Keywords: Biologic Samples; Hydrocortisone; Laboratory Research Specimens; Glucocorticoids; Immune Modulation; Healthy Volunteer; HV