InfluenzaPhase 3NCT03139565
High Dose vs. Standard Influenza Vaccine in Adult SOT
A Phase 3 study testing Fluzone High-dose Influenza Vaccine and Standard 2016-2017 Flu vaccine in people with Influenza and Immunosuppression, run by University Health Network, Toronto at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Influenza, Immunosuppression
- What is being tested?
- Fluzone High-dose Influenza Vaccine and Standard 2016-2017 Flu vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2016to Jul 2020
- Phase
- Phase 3
- 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
Who may be able to join
- Organ transplant recipient on at least one immunosuppressive
- Age >=18
- Outpatient status
- Greater than 3 months post transplant
Who cannot join
- 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
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- 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
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: A Randomized Controlled Trial Comparing High-dose vs. Standard Influenza Vaccine in Adult Solid Organ Transplant Recipients
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.
Read the 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
- Being tested
- Fluzone High-dose Influenza Vaccine, Standard 2016-2017 Flu vaccine
- Keywords
- Influenza, Solid Organ Transplant, Infection, Vaccine, Immunogenicity
- Medical subject headings
- Influenza, Human, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluzone High-dose Influenza VaccineBiological
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 vaccineBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| Fluzone High-dose Influenza Vaccine | Experimental | 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. Receives: Biological: Fluzone High-dose Influenza Vaccine |
| Standard 2016-2017 Flu vaccine | Active comparator | 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. Receives: Biological: Standard 2016-2017 Flu vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 weeks
Secondary outcomes (4)
Vaccine Safety (local and systemic adverse events to vaccination).
Vaccine Safety assessed by local and systemic adverse events to vaccination.
Measured: 6 months
Vaccine Safety (rates of rejection).
Vaccine Safety assessed by rates of biopsy proven allograft rejection in the 6 months following vaccination.
Measured: 6 months
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.
Measured: 4 weeks
Vaccine Efficacy (influenza infection)
Microbiology proven influenza infection in the 6 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 posted4 May 2017
- Study startOct 2016
- Primary completionJun 2017
- Study completionJul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deepali Kumar, University Health Network, Toronto
- Investigators
- Deepali Kumar, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03139565
- Sponsor's protocol ID
- UHNTID004
- Status last verified
- Oct 2020
- First submitted
- 6 Apr 2017
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 29253089
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing High-dose vs. Standard Influenza Vaccine in Adult Solid Organ Transplant Recipients
- ClinicalTrials.gov ID
- NCT03139565
- Acronym / sponsor ID
- UHNTID004
- Conditions
- Influenza, Immunosuppression
- Keywords
- Influenza, Solid Organ Transplant, Infection, Vaccine, Immunogenicity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jul 2020 (actual)
- First posted
- 4 May 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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fluzone High-dose Influenza Vaccine | Experimental | Biological: Fluzone High-dose Influenza VaccineThis 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 | Active comparator | Biological: Standard 2016-2017 Flu vaccineThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Organ transplant recipient on at least one immunosuppressive
- Age >=18
- Outpatient status
- Greater than 3 months post transplant
Key exclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| Fluzone High-dose Influenza VaccineThis 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. | Biological | Fluzone High-dose Influenza Vaccine |
| Standard 2016-2017 Flu vaccineThe 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. | Biological | Standard 2016-2017 Flu vaccine |
Primary outcome
Vaccine Immunogenicity (antibody titers)
Time frame: 4 weeks
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 secondary outcomes
Vaccine Safety (local and systemic adverse events to vaccination).
Time frame: 6 months
Vaccine Safety (rates of rejection).
Time frame: 6 months
Vaccine Immunogenicity (CMI)
Time frame: 4 weeks
Vaccine Efficacy (influenza infection)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
- Derived from this study: PubMed 29253089Natori 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.
- 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
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fluzone High-dose Influenza Vaccine and Standard 2016-2017 Flu vaccine in people with Influenza and Immunosuppression, 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: finished, as of the sponsor's last update on 22 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (antibody titers) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03139565, which also lists 1 linked publication.
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 22 Oct 2020.