Standard-dose Versus High-dose Flu Vaccine in Solid Organ Transplant.
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|ClinicalTrials.gov Identifier: NCT01808456|
Recruitment Status : Completed
First Posted : March 11, 2013
Last Update Posted : March 13, 2018
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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||62 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
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
- 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.
- 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.
- All cause hospitalization [ Time Frame: day 1 - 3 months ]Hospitalizations due to respiratory illness, hospitalizations for transplant organ dysfunction (unexpected), or other unanticipated hospitalizations.
- 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).
- Evaluate seroconversion and seroprotection rates [ Time Frame: 3 months ]Percentage of seroconversion (defined as negative pre-vaccination serum (<10) / post-vaccination titer≥ 40)
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 ClinicalTrials.gov identifier (NCT number): NCT01808456
|United States, Virginia|
|Inova Fairfax Hospital|
|Falls Church, Virginia, United States, 22042|
|Principal Investigator:||Ravinder Wali, MD||Inova Fairfax Hospital|