High Dose vs. Standard Influenza Vaccine in Adult SOT

Influenza Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03139565
• Other study ID #: UHNTID004
• Status: Completed
• Phase: Phase 3
• Start date: October 2016
• Est. completion date: July 2020

Study information

• Verified date: October 2020
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 172
• Est. completion date: July 2020
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Immunosuppression
• Influenza
• Influenza, Human

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	University Health Network, Toronto General Hospital, Multi-Organ Transplant	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vaccine Immunogenicity (antibody titers)	Comparing pre-vaccine and 4 weeks Post-Vaccine antibody titers. Positive vaccine response will be defined as: Seroconversion rate of 4-fold or greater increase in HAI antibody titers to each of the three antigens in the vaccine, and; seroprotection rate determined by HAI tigers of 1>=40 post immunization	4 weeks
Secondary	Vaccine Safety (local and systemic adverse events to vaccination).	Vaccine Safety assessed by local and systemic adverse events to vaccination.	6 months
Secondary	Vaccine Safety (rates of rejection).	Vaccine Safety assessed by rates of biopsy proven allograft rejection in the 6 months following vaccination.	6 months
Secondary	Vaccine Immunogenicity (CMI)	Analysis of cell-mediated immunity (CMI) in subgroup of 50 patients at 4 weeks post-vaccination vs pre-vaccination samples. CMI response will be correlated with HAI response.	4 weeks
Secondary	Vaccine Efficacy (influenza infection)	Microbiology proven influenza infection in the 6 months following vaccination.	6 months