Seasonal Influenza Vaccine High Dose Boosting in Solid Organ Transplant Recipients

Solid Organ Transplant Clinical Trial

Official title:

Seasonal Influenza Vaccine High Dose Boosting in Solid Organ Transplant Recipients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05663463
• Other study ID #: NA-Influenza
• Status: Recruiting
• Phase: N/A
• Start date: September 11, 2023
• Est. completion date: December 1, 2025

Study information

• Verified date: October 2023
• Source: University of Minnesota
• Contact: Lauren Fontana, MD
• Phone: 6126245773
• Email: fluvaccinestudy[@]umn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 1, 2025
• Est. primary completion date: September 11, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• >=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

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Solid Organ Transplant

Intervention

Drug:
• Fluzone High-Dose Quadrivalent- 2 doses
2 doses of the High-Dose (HD) influenza vaccine separated by 4-6 weeks
• Fluzone High-Dose Quadrivalent- 1 dose of HD
1 dose of the High Dose (HD) influenza vaccine, followed by a placebo injection 4-6 weeks later

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Secondary	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
Secondary	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.	2 years
Secondary	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
Secondary	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