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Early Flu Shots in SOT

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ClinicalTrials.gov Identifier: NCT03327987
Recruitment Status : Withdrawn (The study was on hold and later withdrawn due to shortage of staff)
First Posted : November 1, 2017
Last Update Posted : October 20, 2020
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

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.

Condition or disease Intervention/treatment
Influenza Solid Organ Transplant Biological: standard of care influenza vaccine

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).

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Safety and Immunogenicity of Influenza Vaccine During the First Post-Transplant Year in Solid Organ Transplant Recipients
Actual Study Start Date : May 7, 2019
Actual Primary Completion Date : May 7, 2019
Actual Study Completion Date : May 7, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Group/Cohort Intervention/treatment
31-90 days
Patient 31-90 days after transplantation receiving standard of care annual 2017-2018 influenza vaccine.
Biological: standard of care influenza vaccine
The standard of care annual 2017-2018 influenza vaccine will be used for this study.
Other Name: annual influenza vaccine

91-180 days
91-180 days after transplantation receiving standard of care annual 2017-2018 influenza vaccine.
Biological: standard of care influenza vaccine
The standard of care annual 2017-2018 influenza vaccine will be used for this study.
Other Name: annual influenza vaccine

181-365 days
181-365 days after transplantation receiving standard of care annual 2017-2018 influenza vaccine.
Biological: standard of care influenza vaccine
The standard of care annual 2017-2018 influenza vaccine will be used for this study.
Other Name: annual influenza vaccine




Primary Outcome Measures :
  1. Vaccine immunogenicity [ Time Frame: 4 weeks ]

    Vaccine immunogenicity based on assessment of pre- and post-vaccine (4 weeks) antibody titer. A positive vaccine response will be defined based on:

    • Seroconversion rate: serological response with a four-fold or greater increase in HAI antibody titers to each of the three antigens in the vaccine, and
    • Seroprotection rate: HAI titers of ≥1:40 to each of the three antigens post-immunization.


Secondary Outcome Measures :
  1. Safety- adverse events [ Time Frame: 7 days ]
    Local and systemic adverse events to vaccination

  2. Safety- graft rejection [ Time Frame: 6 months ]
    Rates of biopsy proven allograft rejection in the 6 months following vaccination

  3. Safety- HLA [ Time Frame: 4 weeks ]
    Development of de novo or increased titer of HLA alloantibody and specifically DSA (donor specific antibody). The 4 weeks post-vaccine sample will be compared with the pre-vaccine samples.

  4. Vaccine efficacy- CMI [ Time Frame: 4 weeks ]
    Analysis of CMI in a subgroup of 60 patients (influenza strain-specific CD4+ and CD8+ T-cell responses; detectable vs. non-detectable and absolute percentage) at four weeks post-vaccine vs. pre-vaccine sample. CMI responses will also be correlated with HAI responses.

  5. Vaccine efficacy- infection [ Time Frame: 6 months ]
    Documented influenza infection (i.e., microbiology proven by the direct fluorescent antibody, viral culture, or PCR) in the six months following vaccination.


Biospecimen Retention:   Samples Without DNA
serum, whole blood


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult solid organ transplant recipients between 31 and 365 days post-transplant.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03327987


Locations
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Canada, Ontario
University Health Network, Toronto General Hospital, Multi-Organ Transplant
Toronto, Ontario, Canada, M5G2N2
Sponsors and Collaborators
University Health Network, Toronto
Investigators
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Principal Investigator: Deepali Kumar, MD UHN
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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT03327987    
Other Study ID Numbers: 17-5960
First Posted: November 1, 2017    Key Record Dates
Last Update Posted: October 20, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Health Network, Toronto:
vaccine immunogenicity
vaccine safety
Additional relevant MeSH terms:
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Influenza, Human
Respiratory Tract Infections
Infections
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs