Standard-dose Versus High-dose Flu Vaccine in Solid Organ Transplant.
Condition: Influenza, Human; Transplantation Infection
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      A potential strategy to enhance immune responses to influenza vaccine in this patient
      population could be to use different strengths of TIV. One of the pathways that can improve
      the immunogenicity of inactivated vaccines is to increase the dose of influenza antigens
      contained in the vaccine. Studies have demonstrated that increasing the dose of the influenza
      virus hemagglutinin for each of the commonly encountered viral strains beyond the
      conventional dose of 15 microgram for each strain is associated with dose-dependent increase
      in serum antibody titers.

      Influenza TIV is commercially available in two different strengths, Fluzone as well as
      Fluzone High-Dose, and it is valuable because of variable immunogenic potency of different
      strengths. Fluzone is approved for use in persons 6 months of age and older. High-dose
      Fluzone is approved for use in persons 65 years of age and older.

      The purpose of this exploratory study is to assess the safety, tolerability, and
      immunogenicity of these two commercially available different strengths of TIV in solid organ
      transplant recipients (kidney, heart and lung) in the period after 30 days after transplant
      procedure. We will evaluate the safety, tolerability (reactogenicity) and immunogenicity of
      two different strengths of commercially available TIV in a single center, cluster
      randomization, investigator blinded, study by enrolling patients in the post-transplant
      clinic at Inova Fairfax Hospital from: August 1, 2013 - March 31, 2014; and August 1, 2014 to
      March 31, 2015.

      Study protocol will remain active till December 31, 2016. All bio-specimens will be stored
      till December 31, 2016.
    

Intervention name(s): influenza trivalent inactive vaccine; influenza trivalent inactive vaccine high dose
Intervention type(s): Biological; Biological
Intervention description(s): 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
Other intervention name(s): Fluzone(R); flu vaccine; Fluzone High Dose (R)
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: kidney transplant; heart transplant; lung transplant; influenza vaccine