High Dose vs. Standard Influenza Vaccine in Adult SOT

NCT ID: NCT03139565

Last Updated: 2020-10-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 172 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2020-07-31

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.

Conditions

Influenza; Immunosuppression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Fluzone High-dose Influenza Vaccine

Intervention Type: BIOLOGICAL

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

This will be the Standard 2016-2017 influenza vaccine made available by public health. It will contain 15 microgram of each strain and will be delivered in the deltoid muscle of non-dominant arm.

Group Type: ACTIVE_COMPARATOR

Standard 2016-2017 Flu vaccine

Intervention Type: BIOLOGICAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Deepali Kumar

Physician, Transplant Infectious Diseases

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Deepali Kumar, MD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Locations

University Health Network, Toronto General Hospital, Multi-Organ Transplant

Toronto, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 29253089 (View on PubMed)

Other Identifiers

UHNTID004

Identifier Type: -

Identifier Source: org_study_id