Evaluate Reactogenicity and Immunogenicity of Standard-dose (SD) Versus High-dose (HD) Inactivated Influenza Vaccine Trivalent (IIV3) in Recipients of Solid Organ Transplants.
Information source: Inova Health Care Services
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Influenza, Human; Transplantation Infection
Intervention: influenza trivalent inactive vaccine (Biological); influenza trivalent inactive vaccine high dose (Biological)
Phase: Phase 4
Status: Recruiting
Sponsored by: Inova Health Care Services Official(s) and/or principal investigator(s): Ravinder Wali, MD, Principal Investigator, Affiliation: Inova Fairfax Hospital
Overall contact: Holly Gallimore, Phone: 703 776 2688, Email: holly.gallimore@inova.org
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.
Clinical Details
Official title: Phase IV, Pilot, Randomized, Investigator-blinded, Study to Evaluate the Reactogenicity and Immunogenicity of Standard-dose (SD) Versus High-dose (HD) Inactivated Influenza Vaccine Trivalent (IIV3) Single Intramuscular Dose Administered 30 Days After Kidney, Heart and Lung Transplantation.
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
Primary outcome: Number of patients with local or systemic reactionsMeasurement of strain-specific hemagglutination inhibition (HI) antibody titers
Secondary outcome: All cause hospitalizationAll cause ED visits/unscheduled clinic visits Evaluate seroconversion and seroprotection rates
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 SOT-R
(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 biospecimens will be stored
till December 31, 2016.
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
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.
Locations and Contacts
Holly Gallimore, Phone: 703 776 2688, Email: holly.gallimore@inova.org
Inova Fairfax Hospital, Falls Church, Virginia 22042, United States; Recruiting Ravinder k Wali, MD, Principal Investigator Mary E Schmidt, MD, Sub-Investigator Adam B Cochrane, PharmD, Sub-Investigator Shashank Desai, MD, Sub-Investigator Steven Nathan, MD, Sub-Investigator Johann Jonsson, MD, Sub-Investigator James B Piper, MD, Sub-Investigator
Additional Information
Starting date: October 2013
Last updated: March 13, 2015
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