Standard vs High-Dose Trivalent Inactivated Flu Vaccine in Adult Hematopoetic Stem Cell Transplant (HSCT) Recipients
Condition: Adult Stem Cell Hematopoetic Transplant
Intervention: High-Dose Trivalent Inactivated Influenza Vaccine (HD-TIV); Standard Dose Trivalent Inactivated Flu Vaccine
Intervention description: 0.5 ml of HD-TIV on visit 1; Twenty adult hematopoetic stem cell transplant recipients will receive 0.5 ml standard dose trivalent influenza vaccine on visit 1.
Intervention MeSH terms: Vaccines
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Hypothesis 1: The safety profile in adult allogeneic stem cell hematopoietic transplant (SCT)
      recipients after high dose (HD) trivalent inactivated influenza vaccine (TIV) will not be
      significantly different from adult stem cell transplant recipients receiving standard dose
      (SD) TIV.

        -  Specific Aim 1: To compare safety profile of high dose trivalent inactivated influenza
           vaccine to standard dose trivalent inactivated influenza vaccine in adult hematopoietic
           stem cell transplant recipients.

      Hypothesis 2: Adult stem cell transplant recipients who received the higher dose trivalent
      influenza vaccine will have a greater frequency of (at least a 4-fold) rise in antibody
      titers to influenza antigens compared to those who receive standard dose trivalent influenza
      vaccine.

        -  Specific Aim 2: To compare humoral immune responses of adult hematopoietic stem cell
           transplant recipients influenza virus antigens included in trivalent influenza vaccine
           after high dose or standard dose trivalent influenza vaccine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Allogeneic hematopoietic stem cell transplant recipients who are >6 post-transplant

          -  greater than or equal to 18 years of age

          -  Available for duration of study

          -  If patients are on immunosuppressive therapy for treatment of graft versus host
             disease (GVHD): only those on stable doses for at least 4 weeks or on tapering doses
             will be eligible.

        Exclusion Criteria:

          -  History of hypersensitivity to previous influenza vaccination or hypersensitivity to
             eggs/egg protein

          -  History of Guillain-Barre syndrome

          -  Evidence of hematologic malignancy or disease relapse post-transplant (mixed
             chimerisms and molecular evidence of disease is permitted)

          -  Non-allogeneic (e.g. autologous) hematopoietic SCT recipients

          -  History of receiving 2011 - 2012 influenza vaccine

          -  History of proven influenza disease after September 1, 2011.

          -  Pregnant females

          -  Have any condition that would, in the opinion of the site investigator, place them at
             an unacceptable risk of injury or render them unable to meet the requirements of the
             protocol

          -  Have any condition that the investigator believes may interfere with successful
             completion of the study

          -  Platelet count less than 50,000 cells/μL

          -  History of known infection with HIV, Hepatitis B or Hepatitis C

          -  History of known latex hypersensitivity