Solid Organ TransplantNCT05663463
Seasonal Influenza Vaccine High Dose Boosting in Solid Organ Transplant Recipients
A study testing Fluzone High-Dose - 2 doses and Fluzone High-Dose - 1 dose of HD in people with Solid Organ Transplant, run by University of Minnesota at 1 site in United States.
Trial summary
In solid organ transplant (SOT) the receipt of influenza vaccine in an influenza season is associated with decreased disease severity as demonstrated by the presence of pneumonia and ICU admissions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Organ Transplant
- What is being tested?
- Fluzone High-Dose - 2 doses and Fluzone High-Dose - 1 dose of HD
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Sep 2023to 16 Jun 2025
- Phase
- Interventional
- 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
- >=18 years old who underwent a solid organ transplant (Liver, lung, heart, kidney, pancreas) > 1 year prior to enrollment
- At least 1-year post-transplant
- Able and willing to provide informed consent
- Able and willing to undergo all study activities throughout the duration of the study
Who cannot join
- Confirmed pregnancy
- Receipt of ATG or carfilzomib within the past 3 months
- Receipt of rituximab within the past 3 months
- Receipt of basiliximab within the past 3 months
- Prednisone dose >= 20 mg/day at the time of enrollment
- History of a severe allergy to influenza vaccine (i.e. Guillain Barre syndrome, anaphylaxis or angioedema)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
In solid organ transplant (SOT) the receipt of influenza vaccine in an influenza season is associated with decreased disease severity as demonstrated by the presence of pneumonia and ICU admissions. Different strategies have been assessed to optimize vaccine efficacy and immunogenicity of the influenza vaccine in the solid organ transplant recipient (SOTR). The primary objective of the study is to evaluate the immunogenicity of 2 doses of the high dose influenza vaccine utilizing neutralizing antibody assays. A control group receiving 1 HD influenza vaccine will be included.
- Conditions
- Solid Organ Transplant
- Being tested
- Fluzone High-Dose - 2 doses, Fluzone High-Dose - 1 dose of HD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluzone High-Dose - 2 dosesDrug
2 doses of the High-Dose (HD) influenza vaccine separated by 4-6 weeks For 2023-2024 influenza season the influenza quadrivalent HD vaccine was used. For 2024 -2025 influenza season the influenza trivalent HD vaccine will be used.
Fluzone High-Dose - 1 dose of HDDrug
1 dose of the High Dose (HD) influenza vaccine, followed by a placebo injection 4-6 weeks later For 2023-2024 influenza season the influenza quadrivalent HD vaccine was used. For 2024 -2025 influenza season the influenza trivalent HD vaccine will be used.
| Study group | Role | What they receive |
|---|---|---|
| booster group | Experimental | Participants who have undergone a solid organ transplant will receive two doses of an inactivated high dose influenza vaccine Receives: Drug: Fluzone High-Dose - 2 doses |
| Control group | Active comparator | Participants who have undergone a solid organ transplant will receive one dose of inactivated high dose influenza vaccine followed by a placebo injection Receives: Drug: Fluzone High-Dose - 1 dose of HD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neutralizing antibody levels- Immunogenicity
Geometric mean titers and geometric mean fold rise from baseline of homologue neutralizing antibodies in reporter microneutralization will be measured and compared across groups.
Measured: Baseline
Neutralizing antibody levels- Immunogenicity
Geometric mean titers and geometric mean fold rise from baseline of homologue neutralizing antibodies in reporter microneutralization will be measured and compared across groups.
Measured: 4-6 weeks after dose 1
Neutralizing antibody levels- Immunogenicity
Geometric mean titers and geometric mean fold rise from baseline of homologue neutralizing antibodies in reporter microneutralization will be measured and compared across groups.
Measured: 3 months after 2nd dose
Secondary outcomes (4)
clinical outcome- pneumonia
assess clinical outcome associated with an influenza infection such as pneumonia rates during the 2023-2024 and 2024-2025 influenza seasons.
Measured: 2 years
clinical outcome- hospitalization rates
assess clinical outcome associated with an influenza infection such as hospitalization rates during the 2023-2024 and 2024-2025 influenza seasons.
Measured: 2 years
clinical outcome- ICU admissions
assess clinical outcome associated with an influenza infection such as ICU admission rates during the 2023-2024 and 2024-2025 influenza seasons.
Measured: 2 years
clinical - death rates
assess clinical outcome associated with an influenza infection such as death rates during the 2023-2024 and 2024-2025 influenza seasons.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2022
- Study start11 Sep 2023
- Primary completion16 Jun 2025
- Study completion16 Jun 2025
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 Solid Organ TransplantStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lauren Fontana, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05663463
- Sponsor's protocol ID
- NA-Influenza
- Status last verified
- Jul 2025
- First submitted
- 12 Dec 2022
- Last updated
- 15 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Escandon K, Tang SQ, Forschmiedt J, Low K, Lin BC, Wang JL, Castro M, Narpala S, Serebryannyy LA, Anderson J, Reichel J, Koup RA, Rudser KD, Singam H, Rhein J, Kline S, Schacker TW, Fontana LM. A Randomized, Double-Blind Clinical Trial of One vs Two Doses of High-Dose Influenza Vaccine in Solid Organ Transplant Recipients. Open Forum Infect Dis. 2026 Aug 7;13(8):ofag494. doi: 10.1093/ofid/ofag494. eCollection 2026 Aug.
PubMed 42614627
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seasonal Influenza Vaccine High Dose Boosting in Solid Organ Transplant Recipients
- ClinicalTrials.gov ID
- NCT05663463
- Acronym / sponsor ID
- NA-Influenza
- Conditions
- Solid Organ Transplant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 11 Sep 2023 (actual)
- Primary completion
- 16 Jun 2025 (actual)
- Study completion
- 16 Jun 2025 (actual)
- First posted
- 23 Dec 2022 (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.
In solid organ transplant (SOT) the receipt of influenza vaccine in an influenza season is associated with decreased disease severity as demonstrated by the presence of pneumonia and ICU admissions. Different strategies have been assessed to optimize vaccine efficacy and immunogenicity of the influenza vaccine in the solid organ transplant recipient (SOTR). The primary objective of the study is to evaluate the immunogenicity of 2 doses of the high dose influenza vaccine utilizing neutralizing antibody assays. A control group receiving 1 HD influenza vaccine will be included.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| booster group | Experimental | Drug: Fluzone High-Dose - 2 dosesParticipants who have undergone a solid organ transplant will receive two doses of an inactivated high dose influenza vaccine |
| Control group | Active comparator | Drug: Fluzone High-Dose - 1 dose of HDParticipants who have undergone a solid organ transplant will receive one dose of inactivated high dose influenza vaccine followed by a placebo injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- >=18 years old who underwent a solid organ transplant (Liver, lung, heart, kidney, pancreas) > 1 year prior to enrollment
- At least 1-year post-transplant
- Able and willing to provide informed consent
- Able and willing to undergo all study activities throughout the duration of the study
Key exclusion criteria (6 listed)
- Confirmed pregnancy
- Receipt of ATG or carfilzomib within the past 3 months
- Receipt of rituximab within the past 3 months
- Receipt of basiliximab within the past 3 months
- Prednisone dose >= 20 mg/day at the time of enrollment
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 - 2 doses2 doses of the High-Dose (HD) influenza vaccine separated by 4-6 weeks For 2023-2024 influenza season the influenza quadrivalent HD vaccine was used. For 2024 -2025 influenza season the influenza trivalent HD vaccine will be used. | Drug | booster group |
| Fluzone High-Dose - 1 dose of HD1 dose of the High Dose (HD) influenza vaccine, followed by a placebo injection 4-6 weeks later For 2023-2024 influenza season the influenza quadrivalent HD vaccine was used. For 2024 -2025 influenza season the influenza trivalent HD vaccine will be used. | Drug | Control group |
Primary outcome
Neutralizing antibody levels- Immunogenicity
Time frame: Baseline
Geometric mean titers and geometric mean fold rise from baseline of homologue neutralizing antibodies in reporter microneutralization will be measured and compared across groups.
Neutralizing antibody levels- Immunogenicity
Time frame: 4-6 weeks after dose 1
Geometric mean titers and geometric mean fold rise from baseline of homologue neutralizing antibodies in reporter microneutralization will be measured and compared across groups.
Neutralizing antibody levels- Immunogenicity
Time frame: 3 months after 2nd dose
Geometric mean titers and geometric mean fold rise from baseline of homologue neutralizing antibodies in reporter microneutralization will be measured and compared across groups.
4 secondary outcomes
clinical outcome- pneumonia
Time frame: 2 years
clinical outcome- hospitalization rates
Time frame: 2 years
clinical outcome- ICU admissions
Time frame: 2 years
clinical - death rates
Time frame: 2 years
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 15 Jul 2025.
- Derived from this study: PubMed 42614627Escandon K, Tang SQ, Forschmiedt J, Low K, Lin BC, Wang JL, Castro M, Narpala S, Serebryannyy LA, Anderson J, Reichel J, Koup RA, Rudser KD, Singam H, Rhein J, Kline S, Schacker TW, Fontana LM. A Randomized, Double-Blind Clinical Trial of One vs Two Doses of High-Dose Influenza Vaccine in Solid Organ Transplant Recipients. Open Forum Infect Dis. 2026 Aug 7;13(8):ofag494. doi: 10.1093/ofid/ofag494. eCollection 2026 Aug.
Related trials for Solid Organ Transplant
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High vs.Standard Dose Influenza Vaccine in Pediatric Solid Organ Transplant (SOT) Recipients
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COVID-19 Booster and IIV Schedule in Immunocompromised Hosts
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Active, not recruitingPhase 2
Viral Specific T-cells for Treatment of Viral Infections After Solid Organ Transplant
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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.
Lauren Fontana, MD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluzone High-Dose - 2 doses and Fluzone High-Dose - 1 dose of HD in people with Solid Organ Transplant, run by University of Minnesota at 1 site in United States.
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 6 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 15 Jul 2025. 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 United States. 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 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?
Neutralizing antibody levels- Immunogenicity (time frame: Baseline). The study lists 3 primary outcomes in all. 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 NCT05663463, 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 15 Jul 2025.