Clinical trial NCT03139565: High Dose vs. Standard Influenza Vaccine in Adult SOT
Official title: A Randomized Controlled Trial Comparing High-dose vs. Standard Influenza Vaccine in Adult Solid Organ Transplant Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza
Immunosuppression
Keywords: Influenza
Solid Organ Transplant
Infection
Vaccine
Immunogenicity
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2017-05-04
Enrollment: 172
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study will test whether a high dose influenza vaccination results in improved immunogenicity in adult SOT recipients as compared to standard vaccine. This will be a single center prospective observer-blind randomized controlled trial conducted at the Toronto General Hospital Multi-Organ Transplant Unit, University Health Network, Toronto, Ontario, Canada.

Detailed description: Influenza virus is an important cause of morbidity and mortality in the transplant population and can lead to viral and bacterial pneumonia. Although the annual influenza vaccine is recommended for transplant patients, studies have shown that standard vaccine has poor immunogenicity. Currently, there are no studies that define the effect of high-dose vaccine in adult transplant recipients even though this population could potentially benefit from it. The study will compare the immunogenicity of two different types of the influenza vaccine in 240 solid organ transplant patients during the 2016-2017 season. Patients will be randomized to receive either high-dose or standard dose influenza vaccine. Antibody titers will be evaluated by a standard hemagglutination inhibition assay. The hypothesis is that the patients who receive the high-dose influenza vaccine will reach a significantly greater response to the vaccine. This study advances research on the prevention of serious viral infections in transplant recipients. Results from this study have the potential to directly improve patient care. If the use of the high-dose influenza vaccine is successful, this strategy may lead to significant reduction in burden of disease, hospitalization, and long-term morbidity.

Eligibility criteria: Inclusion Criteria:

* Organ transplant recipient on at least one immunosuppressive
* Age \>=18
* Outpatient status
* Greater than 3 months post transplant

Exclusion Criteria:

* Has already received influenza vaccination for 2016-2017 season
* Egg allergy or allergy to previous influenza vaccine
* Febrile illness in the past one week
* Active Cytomegalovirus viremia
* Use of Rituximab in the past 6 months
* Ongoing or recent (in past 30 days) therapy for acute rejection
* Chronic kidney insufficiency (creatinine clearance ≤30mL/min or dialysis-dependent
* Previous life-threatening reaction to influenza vaccine (i.e. Guillain Barre Syndrome)
* Receipt of intravenous immunoglobulin (IVIG) in the past 30 days or planning to receive IVIG in the next 4 weeks

Primary outcomes:
measure: Vaccine Immunogenicity (antibody titers)
timeFrame: 4 weeks
Secondary outcomes:
measure: Vaccine Safety (local and systemic adverse events to vaccination).
timeFrame: 6 months
measure: Vaccine Safety (rates of rejection).
timeFrame: 6 months
measure: Vaccine Immunogenicity (CMI)
timeFrame: 4 weeks
measure: Vaccine Efficacy (influenza infection)
timeFrame: 6 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network, Toronto General Hospital, Multi-Organ Transplant
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Deepali Kumar, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Natori Y, Shiotsuka M, Slomovic J, Hoschler K, Ferreira V, Ashton P, Rotstein C, Lilly L, Schiff J, Singer L, Humar A, Kumar D. A Double-Blind, Randomized Trial of High-Dose vs Standard-Dose Influenza Vaccine in Adult Solid-Organ Transplant Recipients. Clin Infect Dis. 2018 May 17;66(11):1698-1704. doi: 10.1093/cid/cix1082.