Standard-dose Versus High-dose Flu Vaccine in Solid Organ Transplant.
Condition: Influenza, Human; Transplantation Infection
MeSH terms: Influenza, Human
Intervention: influenza trivalent inactive vaccine; influenza trivalent inactive vaccine high dose
Intervention description: one time IM injection of standard influenza vaccine to measure immunogenicity, safety, and efficacy in organ transplant recipients; one time IM injection of high dose influenza vaccine to measure immunogenicity, safety, and efficacy in organ transplant recipients
Intervention MeSH terms: Vaccines
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 62.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: kidney transplant; heart transplant; lung transplant; influenza vaccine

Summary:

      Influenza infection in recipients of solid organ transplants recipients while on maintenance
      immunosuppressant therapy is associated with increased morbidity and mortality. Although
      influenza vaccination is recommended in these high-risk patients, safety and immunogenicity
      of commercially available different strengths of influenza vaccine have not been established.

      The primary study objective is to determine the safety and immunogenicity of Fluzone and
      Fluzone High-Dose, with a secondary objective to determine the tolerability and efficacy of
      two different strengths of trivalent influenza vaccine (TIV, flu vaccine). Both vaccines are
      commercially available for use in the general population. Fluzone is approved for use in 6
      months of age and older, and Fluzone High-Dose is approved for use in 65 years of age and
      older.

      This is an exploratory, open-label, parallel group, observer blinded, prospective study. All
      recipients of kidney, lung, heart transplants who attend for post-transplant follow-up, at
      least 30-days after transplantation at Inova Fairfax Hospital Transplant Center will be
      eligible for enrollment.

      Enrolled patients will be followed for three months (a total of 4 visits) following
      enrollment and randomization: day 0 (enrollment) and follow-up visits at weeks 1, 4, 8, and
      12.
    

Eligibility criteria:

        Inclusion Criteria:

          1. All adults age ≥18 years of age following solid organ transplants (kidney, heart and
             lung) of all races and gender unless as specified in the exclusion criteria.

          2. At least 30 days after organ transplantation of kidney, heart, or lung.

          3. In good health as determined by a) medical history, b) physical examinations, c)
             clinical judgment of the investigator team.

          4. Informed consent will be obtained from all the subjects before enrollment into the
             study, after the nature of the study has been fully explained to the satisfaction of
             the participant.

          5. Non-English speaking persons will be included ONLY if consent can be obtained with the
             help of the translator or interpreter.

        Exclusion Criteria:

          1. Less than 30 days after transplantation procedure.

          2. Post operative complications of any type.

          3. Transplant organ dysfunction and/or under evaluation for possible infection.

          4. Recent acute transplant rejection and treatment for rejection for the past 30 days.

          5. Receiving another investigational drug or biologic for transplant.

          6. Previous history of allergic reaction to influenza vaccine, chicken egg or other
             unknown allergic reactions to flu vaccine or other vaccines.

          7. Acute ongoing respiratory illness.

          8. Bleeding diathesis or on anticoagulation therapy.

          9. Major surgery (pre-arranged) planned during the study period.

         10. Any condition that may preclude the participant from completion of study related
             activities; such as planned travel, or out of the state of residence and not able to
             return for follow-up visits or relocation of residence.

         11. Females of reproductive age unless proven to be urine HCG negative at the time of
             participation.

         12. Recent opportunistic infection, such as CMV, EBV, BK viral reactivation, or any other
             documented or laboratory confirmed opportunistic infection or on treatment for
             confirmed infection.

         13. Vulnerable subjects such as aged less than 18 years, pregnant women, nursing home
             residents or other institutionalized persons, students, employees, prisoners, and
             persons who may not be able to make independent decisions or is considered to have a
             cognitive impairment, or non-English speaking in the absence of a reliable interpreter
             or translator.