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Standard-dose Versus High-dose Flu Vaccine in Solid Organ Transplant.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01808456
Recruitment Status : Completed
First Posted : March 11, 2013
Last Update Posted : March 13, 2018
Information provided by (Responsible Party):
Inova Health Care Services

Brief 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.

Condition or disease Intervention/treatment Phase
Influenza, Human Transplantation Infection Biological: influenza trivalent inactive vaccine Biological: influenza trivalent inactive vaccine high dose Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Phase IV, Pilot, Randomized, Investigator-blinded, Study to Evaluate the Reactogenicity and Immunogenicity of Standard-dose Versus High-dose Inactivated Influenza Vaccine After Kidney, Heart and Lung Transplantation.
Study Start Date : October 2013
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: High Dose Flu Vaccine
influenza trivalent inactive vaccine high dose. IM (intramuscular) injection one time administration
Biological: influenza trivalent inactive vaccine high dose
one time IM injection of high dose influenza vaccine to measure immunogenicity, safety, and efficacy in organ transplant recipients
Other Name: Fluzone High Dose (R)

Active Comparator: Flu Vaccine
influenza trivalent inactive vaccine IM injection one time administration
Biological: influenza trivalent inactive vaccine
one time IM injection of standard influenza vaccine to measure immunogenicity, safety, and efficacy in organ transplant recipients
Other Names:
  • Fluzone(R)
  • flu vaccine

Primary Outcome Measures :
  1. Number of patients with local or systemic reactions [ Time Frame: Day 1 and weeks 1, 4, 8 and 12 ]
    Evaluation of local and systemic reactions, use of analgesics or antipyretics.

  2. Measurement of strain-specific hemagglutination inhibition (HI) antibody titers [ Time Frame: Week 1, 4, 8 and 12 ]
    Mean geometric titers (GMT) in HI antibody, percentage of subjects achieving HI titer≥40, Mean geometric increase >2.

Secondary Outcome Measures :
  1. All cause hospitalization [ Time Frame: day 1 - 3 months ]
    Hospitalizations due to respiratory illness, hospitalizations for transplant organ dysfunction (unexpected), or other unanticipated hospitalizations.

  2. All cause ED visits/unscheduled clinic visits [ Time Frame: day 1 - 3 months ]
    All-cause outpatient/Emergency department visits during study follow-up (other than pre-specified post transplant follow-up visits).

  3. Evaluate seroconversion and seroprotection rates [ Time Frame: 3 months ]
    Percentage of seroconversion (defined as negative pre-vaccination serum (<10) / post-vaccination titer≥ 40)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01808456

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United States, Virginia
Inova Fairfax Hospital
Falls Church, Virginia, United States, 22042
Sponsors and Collaborators
Inova Health Care Services
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Principal Investigator: Ravinder Wali, MD Inova Fairfax Hospital
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Responsible Party: Inova Health Care Services Identifier: NCT01808456    
Other Study ID Numbers: IFH20132015
First Posted: March 11, 2013    Key Record Dates
Last Update Posted: March 13, 2018
Last Verified: March 2018
Keywords provided by Inova Health Care Services:
kidney transplant
heart transplant
lung transplant
influenza vaccine
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Immunologic Factors
Physiological Effects of Drugs