Immunogenicity of Fluzone High Dose in Immunocompromised Children and Young Adults
Condition: Solid Organ Transplant Recipient (Liver, Kidney, Heart); Rheumatologic Disorder; Human Immunodeficiency Virus (HIV); Bone Marrow Transplant (BMT); Dialysis
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Rheumatic Diseases; Collagen Diseases
Intervention: Fluzone High Dose; Fluzone
Intervention description: A single-dose of high-dose influenza vaccine will be administered to subjects randomized to this arm; A single-dose of standard-dose influenza vaccine will be administered to subjects randomized to this arm
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 16.0
Sex: All
Minimum age: 5 Years
Maximum age: 35 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether Fluzone High Dose increases the immune
      response to the influenza antigens contained in the vaccine compared to standard-dose Fluzone
      in immunocompromised children and young adults. Safety and efficacy data will also be
      collected.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥ 5 years and ≤ 35 years

          -  Receiving influenza vaccination in Children's Hospital Colorado (CHC) clinic as part
             of routine clinical care

          -  Only supposed to receive one dose of influenza vaccine

          -  Rheumatology patients: must be on some type of immunosuppressive or immunomodulatory
             medication at the time of immunization and considered at least moderately
             immunosuppressed in the opinion of the primary rheumatologist. Basic guidelines for
             rheumatology patients: (1) Any patient receiving monoclonal antibody therapy (i.e.,
             infliximab, etanercept, tocilizumab, anakinra) must also be taking another
             immunosuppressive/immunomodulatory medication; (2) Patients taking steroids as
             monotherapy must be on a dose of ≥ 2mg/kg/day OR ≥ 20mg/day; (3) Patients on
             combination therapy where the dose of a single drug may not be very high, but the
             combination is considered moderately or severely immunosuppressive will be eligible.

          -  Bone Marrow Transplant patients: all patients in clinic eligible

          -  Oncology patients: must be on some type of chemotherapy

          -  Hemodialysis patients: must be on dialysis

          -  Child Health Immunodeficiency Program (CHIP) patients: must have a known diagnosis of
             HIV

          -  Solid Organ Transplant patients: post-transplant, influenza vaccine recommended by
             primary transplant physician

        Exclusion Criteria:

          -  Rheumatology patients: if receiving any of the monoclonal antibodies, etanercept,
             infliximab, adalimumab, tocilizumab, atlizumab, or anakinra, must also be taking at
             least one other immunosuppressive/immunomodulatory medication

          -  Unable to come for scheduled follow-up appointments

          -  History of anaphylaxis reaction to influenza vaccination in the past

          -  Severe allergic reaction to any component of the vaccine, including egg protein, or
             after previous dose of any influenza vaccine

          -  History of Guillain-Barre syndrome ever in the past in the subject or in a parent or a
             sibling of the subject

          -  Allergy to latex

          -  Intravenous immuneglobulin (IVIG) within in 4 weeks preceding any blood draw

          -  Receiving an investigational agent as part of another study or other medical treatment
             (investigational = not-FDA approved for any indication)

          -  Subject not enrolled in other studies that prohibit him/her from enrolling in this
             study

          -  Blood draw contraindicated

          -  Pregnancy

          -  Breastfeeding

          -  Received a polysaccharide vaccine (pneumovax) w/in 3 weeks of the vaccination

          -  Absolute neutrophil count (ANC) < 500/uL at the time of vaccination or could
             potentially have ANC 500/uL during the 5 days after vaccination

          -  Platelet count < 50,000/uL at the time of vaccination

          -  If a subject has a temperature ≥ 100.4°F at the time of enrollment, then the subject
             must choose to not enroll or delay immunization until afebrile.

          -  Receiving influenza vaccination past December 15 of influenza season.