Clinical trial NCT03327987: Early Flu Shots in SOT
Official title: Safety and Immunogenicity of Influenza Vaccine During the First Post-Transplant Year in Solid Organ Transplant Recipients
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Influenza
Solid Organ Transplant
Keywords: vaccine immunogenicity
vaccine safety
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2017-11-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult solid organ transplant recipients between 31 and 365 days post-transplant.

Brief summary: Although time from transplant has been a factor in vaccine response, there is limited data on immunizations that occur in the first post-transplant year, and there are no data that suggest influenza vaccination early post-transplant may have any adverse effects on the graft. It is suggested that early vaccinations may lead to reduced immunogenicity due to induction immunosuppression. However, not vaccinating patients may leave them vulnerable to influenza infection for a period of time. This study is designed to look at the immunogenicity and side effects of the standard of care influenza vaccine in patients between 31 and 365 days post-transplant.

Detailed description: Influenza virus is an important cause of morbidity in the transplant population and can lead to viral and bacterial pneumonia. Influenza vaccine is effective in the prevention of influenza infection and is recommended by the Canadian National Advisory Committee on Immunization (NACI). The annual influenza vaccine is suggested for transplant patients as the standard of care starting from 3 months post-transplant. Most recent guidelines now suggest that it is reasonable to get a flu shot starting earlier at 1 month post-transplant. Anti-rejection drugs are now tapered more quickly and it is possible that antibodies will be produced against the flu shot as early as 1 month post-transplant. The study hypothesizes that kidney and liver transplant recipients in the early post-transplant period (31-180 days) will have similar immunogenicity as those in the late post-transplant period (\>180 days).

Eligibility criteria: Inclusion Criteria:

* Kidney, liver or pancreas transplant recipients on at least one immunosuppressive medication
* Age ≥ 18
* Outpatient status
* Greater than 30 days post-transplant

Exclusion Criteria:

* Has already received influenza vaccination for 2017-2018 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 one year
* 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 four weeks

Primary outcomes:
measure: Vaccine immunogenicity
timeFrame: 4 weeks
Secondary outcomes:
measure: Safety- adverse events
timeFrame: 7 days
measure: Safety- graft rejection
timeFrame: 6 months
measure: Safety- HLA
timeFrame: 4 weeks
measure: Vaccine efficacy- CMI
timeFrame: 4 weeks
measure: Vaccine efficacy- 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: UHN
name: Deepali Kumar, MD
role: PRINCIPAL_INVESTIGATOR
References: