High vs. Standard Dose Flu Vaccine in Adult Stem Cell Transplant Recipients
Condition: Hematopoietic Cell Transplantation
Intervention: Quadrivalent Inactivated Influenza Vaccine; Laboratory Biomarker Analysis; Trivalent Influenza Vaccine
Intervention description: Standard Dose Quadrivalent Influenza Vaccine given intramuscularly; Correlative studies; High Dose Trivalent Influenza Vaccine given intramuscularly
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 124.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized phase II studies the side effects of high-dose trivalent influenza vaccine or
      standard-dose quadrivalent inactivated influenza and how well they work in treating adult
      patients undergoing stem cell transplant. Season influenza can cause more severe infections
      in patients who have had a stem cell transplant since their immune system doesn't work as
      well. Influenza vaccine may provide better protection against flu in adults.
    

Eligibility criteria:

        Inclusion criteria

          1. Allogeneic HSCT recipients who are 3-23 months post-transplant;

          2. ≥ 18 years of age;

          3. Available for duration of study;

          4. Patients with stable GVHD for at least 4 weeks will be eligible (stable is defined as
             no major change in systemic immunosuppressive therapy for worsening GVHD; adjustment
             of actual dose to obtain a stable target level is acceptable).

          5. Can be reached by telephone and/or electronic communication

          6. Subjects must have a platelet count of ≥30,000 to receive the immunizations. Patients
             requiring platelet transfusions are eligible to enroll and must have a platelet count
             ≥30,000 within 72 hours prior to their immunization, or platelet count ≥75,000 without
             transfusion documented within 30 days for subjects <12 months post- transplant and
             within 90 days for subjects 12-23 months post-transplant.

        Exclusion criteria

          1. History of hypersensitivity to previous influenza vaccination or severe
             hypersensitivity to eggs/egg protein;

          2. History of Guillain-Barre syndrome;

          3. Evidence of hematologic malignancy or disease relapse post-transplant (stable mixed
             chimerism is permitted);

          4. History of receiving current seasonal influenza vaccine post-transplant;

          5. Pregnant female;

          6. History of proven influenza disease after September 1, 2018 prior to enrollment;

          7. Non-allogeneic (e.g. autologous) or syngeneic hematopoietic SCT recipients;

          8. History of known active infection with HIV

          9. History of cirrhosis

         10. History of known latex hypersensitivity;

         11. Subjects who have received stem cell boost or delayed donor lymphocyte infusion within
             90 days of enrollment, including day of enrollment

         12. Receipt of. IVIG/SCIG <28 days prior to vaccination

        Criteria for temporarily delaying vaccine administration: The following conditions are
        temporary or self-limiting, and a subject may be included in the study once the condition
        has resolved, provided that the subject is otherwise eligible:

          1. Fever ≥100.4ºF/38.0ºC (oral measurement), or an acute illness within 48 hours of
             enrollment

          2. Receipt of any live vaccines within four weeks or any inactivated vaccines within two
             weeks prior to potential study vaccination.

        Note: if patients were eligible for vaccine 1, they will be eligible to receive vaccine 2
        regardless of any changes on their GVHD status, unless it is deemed not medically safe to
        receive influenza vaccine.

        For subjects who were enrolled and vaccinated in 2017-18, and 2018-19, the goal is to
        enroll these same subjects who participated the previous influenza season year and then
        administer the same vaccination as the previous year. These subjects are referred to as
        repeaters. For example, subjects enrolled in 2017-18 year were eligible to enroll again in
        2018-19 as repeaters. For subjects enrolled in 2018-19 year and received at least one
        vaccine, will be eligible to be enrolled as repeaters for 2019-2020 season.