NCT03139565

High Dose vs. Standard Influenza Vaccine in Adult SOT

A Randomized Controlled Trial Comparing High-dose vs. Standard Influenza Vaccine in Adult Solid Organ Transplant Recipients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 172 (actual)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Influenza
• Immunosuppression

Interventions

Type	Name	Description
BIOLOGICAL	Fluzone High-dose Influenza Vaccine	This treatment consists of 60 microgram of each influenza antigen provided as a single injection, which will be injected in the deltoid muscle of the non-dominant arm.
BIOLOGICAL	Standard 2016-2017 Flu vaccine	The intramuscular preparation of the vaccine used for the control group will be the Standard influenza vaccine made available by public health. The intramuscular dose (standard 0.5 mL) will contain 15 microgram antigen from each strain and delivered in the deltoid muscle by trained personnel.

Timeline

• Start date: 2016-10-01
• Primary completion: 2017-06-01
• Completion: 2020-07-01
• First posted: 2017-05-04
• Last updated: 2020-10-22

Locations

1 site across 1 country: Canada