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Vaccine

High-Dose Flu Vaccine for Solid Organ Transplant Recipients

N/A

Recruiting

Led By Hareesh Singam, MD

Research Sponsored by University of Minnesota

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

>=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

Must not have

Receipt of basiliximab within the past 3 months

Receipt of ATG or carfilzomib within the past 3 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will evaluate how best to optimize influenza vaccine efficacy & immunogenicity in solid organ transplant recipients, to reduce severity of disease.

Who is the study for?

This trial is for adults over 18 who had a solid organ transplant (like liver, lung, heart, kidney, pancreas) more than a year ago. They must be able to consent and participate in all study activities. People can't join if they've recently received certain immune therapies or high-dose steroids, are pregnant, or have had severe allergies to flu vaccines.

What is being tested?

The trial is testing the effectiveness of giving two doses of Fluzone High-Dose Quadrivalent influenza vaccine compared to just one dose in people who have received solid organ transplants. The goal is to see which strategy better stimulates the body's defenses against the flu.

What are the potential side effects?

Possible side effects from the Fluzone High-Dose vaccine may include pain at injection site, muscle aches, headache, fatigue and fever. Severe allergic reactions are rare but can occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am over 18 and had an organ transplant more than a year ago.

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I had my transplant surgery over a year ago.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have received basiliximab in the last 3 months.

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I have received ATG or carfilzomib in the last 3 months.

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I am taking 20 mg or more of prednisone daily.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Neutralizing antibody levels- Immunogenicity

Secondary study objectives

clinical - death rates

clinical outcome- ICU admissions

clinical outcome- hospitalization rates

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: booster groupExperimental Treatment1 Intervention

Participants who have undergone a solid organ transplant will receive two doses of an inactivated high dose influenza vaccine

Group II: Control groupActive Control1 Intervention

Participants who have undergone a solid organ transplant will receive one dose of inactivated high dose influenza vaccine followed by a placebo injection

0 / 5Eligibility criteria met