Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03139565
Other study ID # UHNTID004
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT05523089 - The Effectiveness of CD388 to Prevent Flu in an Influenza Challenge Model in Healthy Adults Phase 2
Completed NCT05009251 - Using Explainable AI Risk Predictions to Nudge Influenza Vaccine Uptake N/A
Completed NCT03282240 - Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine in Participants ≥65 Years in the US Phase 3
Completed NCT00968526 - Study to Evaluate Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1) in Adults Phase 3
Completed NCT00971425 - Evaluation of the Immune Response and the Safety of a Pandemic Influenza Candidate Vaccine (H1N1) Phase 3
Completed NCT00968539 - Study to Evaluate the Immunogenicity & Safety of an Investigational Influenza Vaccine (H1N1) in Adults Phase 3
Completed NCT05525494 - Patient Portal Flu Vaccine Reminders (5) N/A
Completed NCT04074928 - Safety and Immunogenicity Study of QIVc in Healthy Pediatric Subjects Phase 3
Completed NCT04695717 - This Study Was Conducted to Evaluate the Safety and Immunogenicity of IVACFLU-S Produced in Children From 6 Months to Under 18 Years Old and the Elderly Over 60 Years Old in Vietnam Phase 3
Completed NCT05012163 - Lottery Incentive Nudges to Increase Influenza Vaccinations N/A
Completed NCT03888989 - Response to Influenza Vaccine During Pregnancy Phase 1
Completed NCT04109222 - Collection of Serum Samples From Children and Older Adults Receiving the 2019-2020 Formulations of Fluzone® Quadrivalent and Fluzone® High-Dose Influenza Vaccines, Respectively Phase 4
Completed NCT02587221 - Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of an MF59-Adjuvanted Quadrivalent Influenza Vaccine Compared to Non-influenza Vaccine Comparator in Adults ≥ 65 Years of Age Phase 3
Completed NCT03453801 - The Role of CD4+ Memory Phenotype, Memory, and Effector T Cells in Vaccination and Infection Phase 1
Completed NCT01440387 - A Study of Immunogenicity and Safety of GSK Biologicals' Influenza Vaccine FLU-Q-QIV in Adults Aged 18 Years and Older Phase 3
Terminated NCT01195779 - Trial to Evaluate Safety and Immunogenicity of GSK Biologicals' Influenza Vaccine GSK2584786A in Healthy Children Phase 2
Completed NCT03321968 - Lot-to-lot Consistency of a Plant-Derived Quadrivalent Virus-Like Particles Influenza Vaccine in Healthy Adults Phase 3
Completed NCT00972517 - Study to Evaluate the Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1) in Children Phase 3
Completed NCT04570904 - Broadening Our Understanding of Early Versus Late Influenza Vaccine Effectiveness
Recruiting NCT03331991 - Prevention of Influenza and Other Wintertime Respiratory Viruses Among Healthcare Professionals in Israel N/A