InfluenzaNCT03327987
Early Flu Shots in SOT
An observational study of Influenza and Solid Organ Transplant, run by University Health Network, Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Influenza, Solid Organ Transplant
- Type of treatment
- Vaccines
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- 7 May 2019to 7 May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult solid organ transplant recipients between 31 and 365 days post-transplant.
Who may be able to join
- Kidney, liver or pancreas transplant recipients on at least one immunosuppressive medication
- Age ≥ 18
- Outpatient status
- Greater than 30 days post-transplant
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
University Health Network, Toronto General Hospital, Multi-Organ Transplant
Toronto, Ontario, M5G2N2
About this study
Official title: Safety and Immunogenicity of Influenza Vaccine During the First Post-Transplant Year in Solid Organ Transplant Recipients
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.
Read the 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).
- Conditions
- Influenza, Solid Organ Transplant
- Being tested
- standard of care influenza vaccine
- Keywords
- vaccine immunogenicity, vaccine safety
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard of care influenza vaccineBiological
Also called annual influenza vaccine
The standard of care annual 2017-2018 influenza vaccine will be used for this study.
| Study group | Role | What they receive |
|---|---|---|
| 31-90 days | Patient 31-90 days after transplantation receiving standard of care annual 2017-2018 influenza vaccine. Receives: Biological: standard of care influenza vaccine | |
| 91-180 days | 91-180 days after transplantation receiving standard of care annual 2017-2018 influenza vaccine. Receives: Biological: standard of care influenza vaccine | |
| 181-365 days | 181-365 days after transplantation receiving standard of care annual 2017-2018 influenza vaccine. Receives: Biological: standard of care influenza vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaccine immunogenicity
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.
Measured: 4 weeks
Secondary outcomes (5)
Safety- adverse events
Local and systemic adverse events to vaccination
Measured: 7 days
Safety- graft rejection
Rates of biopsy proven allograft rejection in the 6 months following vaccination
Measured: 6 months
Safety- HLA
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.
Measured: 4 weeks
Vaccine efficacy- CMI
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.
Measured: 4 weeks
Vaccine efficacy- infection
Documented influenza infection (i.e., microbiology proven by the direct fluorescent antibody, viral culture, or PCR) in the six months following vaccination.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2017
- Study start7 May 2019
- Primary completion7 May 2019
- Study completion7 May 2019
Why it stopped: The study was on hold and later withdrawn due to shortage of staff
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Deepali Kumar, MD, Principal investigator, UHN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03327987
- Sponsor's protocol ID
- 17-5960
- Status last verified
- Oct 2020
- First submitted
- 27 Oct 2017
- Last updated
- 20 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Immunogenicity of Influenza Vaccine During the First Post-Transplant Year in Solid Organ Transplant Recipients
- ClinicalTrials.gov ID
- NCT03327987
- Acronym / sponsor ID
- 17-5960
- Conditions
- Influenza, Solid Organ Transplant
- Keywords
- vaccine immunogenicity, vaccine safety
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The study was on hold and later withdrawn due to shortage of staff
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 7 May 2019 (actual)
- Primary completion
- 7 May 2019 (actual)
- Study completion
- 7 May 2019 (actual)
- First posted
- 1 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 31-90 days | – | Biological: standard of care influenza vaccinePatient 31-90 days after transplantation receiving standard of care annual 2017-2018 influenza vaccine. |
| 91-180 days | – | Biological: standard of care influenza vaccine91-180 days after transplantation receiving standard of care annual 2017-2018 influenza vaccine. |
| 181-365 days | – | Biological: standard of care influenza vaccine181-365 days after transplantation receiving standard of care annual 2017-2018 influenza vaccine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult solid organ transplant recipients between 31 and 365 days post-transplant.
Key inclusion criteria (4 listed)
- Kidney, liver or pancreas transplant recipients on at least one immunosuppressive medication
- Age ≥ 18
- Outpatient status
- Greater than 30 days post-transplant
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| standard of care influenza vaccineAlso: annual influenza vaccineThe standard of care annual 2017-2018 influenza vaccine will be used for this study. | Biological | 181-365 days, 31-90 days, 91-180 days |
Primary outcome
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.
5 secondary outcomes
Safety- adverse events
Time frame: 7 days
Safety- graft rejection
Time frame: 6 months
Safety- HLA
Time frame: 4 weeks
Vaccine efficacy- CMI
Time frame: 4 weeks
Vaccine efficacy- infection
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deepali Kumar, MD principal investigator
UHN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Influenza and Solid Organ Transplant, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 20 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vaccine immunogenicity (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2020.