Seasonal Influenza Vaccine High Dose Boosting in Solid Organ Transplant Recipients

• Sponsor: University of Minnesota (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05663463
• Collaborator: (none)
• Enrollment: 94
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 5.9
• Patients Per Site Per Month: 15.8

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Solid Organ Transplant	Drug: Fluzone High-Dose Quadrivalent- 2 doses; Drug: Fluzone High-Dose Quadrivalent- 1 dose	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 94 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Seasonal Influenza Vaccine High Dose Boosting in Solid Organ Transplant Recipients
• Anticipated Study Start Date: Jan 1, 2023
• Anticipated Primary Completion Date: May 1, 2023
• Anticipated Study Completion Date: Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: booster group Participants who have undergone a solid organ transplant will receive two doses of an inactivated high dose influenza vaccine	Drug: Fluzone High-Dose Quadrivalent- 2 doses; 2 doses of the High-Dose (HD) influenza vaccine separated by 4-6 weeks
Active Comparator: Control group Participants who have undergone a solid organ transplant will receive one dose of inactivated high dose influenza vaccine	Drug: Fluzone High-Dose Quadrivalent- 1 dose; 1 dose of the HD dose influenza vaccine

Outcome Measures

Primary Outcome Measures

1. Neutralizing antibody levels- Immunogenicity [Baseline]

   vaccination. Neutralizing antibody levels for the four influenza strains will be measured using microneutralization assays. We will assess for seroconversion which is defined was as a four fold rise from a base line titer and seroprotection which is a titer level > 1:40.

2. Neutralizing antibody levels- Immunogenicity [4-6 weeks after dose 1]

   vaccination. Neutralizing antibody levels for the four influenza strains will be measured using microneutralization assays. We will assess for seroconversion which is defined was as a four fold rise from a base line titer and seroprotection which is a titer level > 1:40.

3. Neutralizing antibody levels- Immunogenicity [3 months after 2nd dose]

   vaccination. Neutralizing antibody levels for the four influenza strains will be measured using microneutralization assays. We will assess for seroconversion which is defined was as a four fold rise from a base line titer and seroprotection which is a titer level > 1:40.

Secondary Outcome Measures

1. outcomes associated with an influenza infection- Hospitalization rate [6 months after baseline]

2. outcomes associated with an influenza infection- ICU admissions [6 months after baseline]

3. outcomes associated with an influenza infection- death rate [6 months after baseline]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• =18 years old who underwent a solid organ transplant (Liver, lung, heart, kidney, pancreas) prior to September 1 st ,2021.

• Without history of any of the conditions listed in the exclusion criteria.

• At least 1-year post-transplant

• Able and willing to sign informed consent form

• Available for lab visits for 4 months after initial enrollment

Exclusion Criteria:

• Confirmed pregnancy

• Receipt of ATG or carfilzomib within 3 months

• Receipt of rituximab within 3 months

• Receipt of basiliximab within 3 months

• Prednisone dose > 20 mg at the time of enrollment

• History of a severe allergy to influenza vaccine (i.e. Guillain Barre syndrome, anaphylaxis or angioedema)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Minnesota	Minneapolis	Minnesota	United States	55455

Sponsors and Collaborators

• University of Minnesota

Investigators

• Principal Investigator: Lauren Fontana, MD, University of Minnesota

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Minnesota
• ClinicalTrials.gov Identifier: NCT05663463
• Other Study ID Numbers: NA-Influenza
• First Posted: Dec 23, 2022
• Last Update Posted: Dec 23, 2022
• Last Verified: Dec 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Dec 23, 2022