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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| booster group | Experimental | Participants who have undergone a solid organ transplant will receive two doses of an inactivated high dose influenza vaccine |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluzone High-Dose - 2 doses | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 3 months after 2nd dose |
| Measure | Description | Time Frame |
|---|---|---|
| clinical outcome- pneumonia | assess clinical outcome associated with an influenza infection such as pneumonia rates during the 2023-2024 and 2024-2025 influenza seasons. | 2 years |
| clinical outcome- hospitalization rates |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lauren Fontana, MD | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
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| ID | Term |
|---|---|
| D007252 | Influenza Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Fluzone High-Dose - 1 dose of HD | Drug | 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. |
|
assess clinical outcome associated with an influenza infection such as hospitalization rates during the 2023-2024 and 2024-2025 influenza seasons.
| 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. | 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. | 2 years |