Back to resultsStandard-dose Versus High-dose Flu Vaccine in Solid Organ Transplant.
Primary Purpose
Influenza, Human, Transplantation Infection
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
influenza trivalent inactive vaccine
influenza trivalent inactive vaccine high dose
Sponsored by
About this trial
This is an interventional prevention trial for Influenza, Human focused on measuring kidney transplant, heart transplant, lung transplant, influenza vaccine
Eligibility Criteria
Inclusion Criteria:
- 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.
- At least 30 days after organ transplantation of kidney, heart, or lung.
- In good health as determined by a) medical history, b) physical examinations, c) clinical judgment of the investigator team.
- 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.
- Non-English speaking persons will be included ONLY if consent can be obtained with the help of the translator or interpreter.
Exclusion Criteria:
- Less than 30 days after transplantation procedure.
- Post operative complications of any type.
- Transplant organ dysfunction and/or under evaluation for possible infection.
- Recent acute transplant rejection and treatment for rejection for the past 30 days.
- Receiving another investigational drug or biologic for transplant.
- Previous history of allergic reaction to influenza vaccine, chicken egg or other unknown allergic reactions to flu vaccine or other vaccines.
- Acute ongoing respiratory illness.
- Bleeding diathesis or on anticoagulation therapy.
- Major surgery (pre-arranged) planned during the study period.
- 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.
- Females of reproductive age unless proven to be urine HCG negative at the time of participation.
- 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.
- 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.
Sites / Locations
- Inova Fairfax Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
High Dose Flu Vaccine
Flu Vaccine
Arm Description
influenza trivalent inactive vaccine high dose. IM (intramuscular) injection one time administration
influenza trivalent inactive vaccine IM injection one time administration
Outcomes
Primary Outcome Measures
Number of Patients With Local Site Reactions
Evaluation of local and systemic reactions, use of analgesics or antipyretics.
Measurement of Strain-specific Hemagglutination Inhibition (HI) Antibody Titers
Number of patients and percentage of subjects achieving hemagglutination inhibition (HI) titer≥40
Secondary Outcome Measures
All Cause ED Visits/Unscheduled Clinic Visits
All-cause outpatient/Emergency department visits during study follow-up (other than pre-specified post transplant follow-up visits).
Number and Percentage of Subjects in Each Group Achieving Seroconversion for Each Strain
Number and percentage of subjects in each group achieving seroconversion (at least 4-fold increase in titers from baseline) for each any strain at weeks 4 and 12
Full Information
NCT ID
NCT01808456
First Posted
March 4, 2013
Last Updated
July 20, 2022
Sponsor
Inova Health Care Services
1. Study Identification
Unique Protocol Identification Number
NCT01808456
Brief Title
Standard-dose Versus High-dose Flu Vaccine in Solid Organ Transplant.
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 Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Inova Health Care Services
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza, Human, Transplantation Infection
Keywords
kidney transplant, heart transplant, lung transplant, influenza vaccine
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High Dose Flu Vaccine
Arm Type
Experimental
Arm Description
influenza trivalent inactive vaccine high dose. IM (intramuscular) injection one time administration
Arm Title
Flu Vaccine
Arm Type
Active Comparator
Arm Description
influenza trivalent inactive vaccine IM injection one time administration
Intervention Type
Biological
Intervention Name(s)
influenza trivalent inactive vaccine
Other Intervention Name(s)
Fluzone(R), flu vaccine
Intervention Description
one time IM injection of standard influenza vaccine to measure immunogenicity, safety, and efficacy in organ transplant recipients
Intervention Type
Biological
Intervention Name(s)
influenza trivalent inactive vaccine high dose
Other Intervention Name(s)
Fluzone High Dose (R)
Intervention Description
one time IM injection of high dose influenza vaccine to measure immunogenicity, safety, and efficacy in organ transplant recipients
Primary Outcome Measure Information:
Title
Number of Patients With Local Site Reactions
Description
Evaluation of local and systemic reactions, use of analgesics or antipyretics.
Time Frame
Day 1 and weeks 1, 4, and 12
Title
Measurement of Strain-specific Hemagglutination Inhibition (HI) Antibody Titers
Description
Number of patients and percentage of subjects achieving hemagglutination inhibition (HI) titer≥40
Time Frame
Week 1, 4, and 12
Secondary Outcome Measure Information:
Title
All Cause ED Visits/Unscheduled Clinic Visits
Description
All-cause outpatient/Emergency department visits during study follow-up (other than pre-specified post transplant follow-up visits).
Time Frame
day 1 - 3 months
Title
Number and Percentage of Subjects in Each Group Achieving Seroconversion for Each Strain
Description
Number and percentage of subjects in each group achieving seroconversion (at least 4-fold increase in titers from baseline) for each any strain at weeks 4 and 12
Time Frame
Week 4 and Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
At least 30 days after organ transplantation of kidney, heart, or lung.
In good health as determined by a) medical history, b) physical examinations, c) clinical judgment of the investigator team.
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.
Non-English speaking persons will be included ONLY if consent can be obtained with the help of the translator or interpreter.
Exclusion Criteria:
Less than 30 days after transplantation procedure.
Post operative complications of any type.
Transplant organ dysfunction and/or under evaluation for possible infection.
Recent acute transplant rejection and treatment for rejection for the past 30 days.
Receiving another investigational drug or biologic for transplant.
Previous history of allergic reaction to influenza vaccine, chicken egg or other unknown allergic reactions to flu vaccine or other vaccines.
Acute ongoing respiratory illness.
Bleeding diathesis or on anticoagulation therapy.
Major surgery (pre-arranged) planned during the study period.
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.
Females of reproductive age unless proven to be urine HCG negative at the time of participation.
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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ravinder Wali, MD
Organizational Affiliation
Inova Fairfax Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Inova Fairfax Hospital
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Standard-dose Versus High-dose Flu Vaccine in Solid Organ Transplant.
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