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Virus Vaccine

High vs Standard Dose Flu Vaccine for Solid Organ Transplant Recipients

Phase 2
Waitlist Available
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
≥1 month and <12 months post-SOT
Age ≥18 years at vaccination
Must not have
History of known active infection with HIV
History of lung or intestine transplant
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 56 (post-vaccination)
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether high-dose or standard-dose influenza vaccines are more effective in organ transplant recipients 1-11 months post-transplant.

Who is the study for?
Adults aged 18+ who are 1-11 months post solid organ transplant (kidney, heart, liver) can join this trial. They must be reachable for follow-ups and not pregnant or have had lung/intestine transplants, severe vaccine allergies, low platelets, Guillain-Barre syndrome, HIV, or recent immunoglobulin therapy.
What is being tested?
The study is testing if a high-dose flu vaccine gives better immunity than the standard dose in new organ transplant recipients. Participants will get either two high doses, two standard doses or one high dose of the flu shot to see which works best.
What are the potential side effects?
Flu vaccines may cause soreness at injection site, mild fever, fatigue or muscle aches. Rarely they could trigger allergic reactions. The higher dose might increase these side effects but is generally considered safe.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I had an organ transplant between 1 and 12 months ago.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have an active HIV infection.
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I have had a lung or intestine transplant.
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I have had Guillain-Barre syndrome in the past.
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I have received this season's flu vaccine after my transplant.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 56 (post-vaccination)
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 56 (post-vaccination) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Geometric Mean Titers of influenza vaccine antibodies.
The number of participants reporting solicited injection site reactions and systemic reactions.
Secondary study objectives
Geometric Mean Titers Ratio of influenza vaccine antibodies (post-/pre-vaccination).
The number of participants achieving seroprotection and seroconversion for influenza virus.

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Two Doses Standard Dose Quadrivalent Inactivated Influenza VaccineExperimental Treatment1 Intervention
two doses of 0.5 mL SD-IIV (15µg of each influenza antigen) 28-42 days apart
Group II: Two Doses High Dose Quadrivalent Inactivated Influenza VaccineExperimental Treatment1 Intervention
two doses of 0.7 mL HD-IIV (60µg of each influenza antigen) 28-42 days apart
Group III: One Dose High Dose Quadrivalent Inactivated Influenza VaccineExperimental Treatment1 Intervention
one dose of 0.7 mL HD-IIV (60µg of each influenza antigen) followed by placebo 28-42 days later

Find a Location

Who is running the clinical trial?

Feinberg School of Medicine, Northwestern UniversityOTHER
33 Previous Clinical Trials
11,848 Total Patients Enrolled
Vanderbilt University Medical CenterLead Sponsor
904 Previous Clinical Trials
933,715 Total Patients Enrolled
Northwestern University Feinberg School of MedicineOTHER
40 Previous Clinical Trials
14,997 Total Patients Enrolled
University of Alabama at BirminghamOTHER
1,647 Previous Clinical Trials
2,342,129 Total Patients Enrolled
University of WashingtonOTHER
1,823 Previous Clinical Trials
1,912,929 Total Patients Enrolled

Media Library

High Dose Quadrivalent Inactivated Influenza Vaccine (Virus Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT04613206 — Phase 2
Transplant Infection Research Study Groups: Two Doses High Dose Quadrivalent Inactivated Influenza Vaccine, Two Doses Standard Dose Quadrivalent Inactivated Influenza Vaccine, One Dose High Dose Quadrivalent Inactivated Influenza Vaccine
Transplant Infection Clinical Trial 2023: High Dose Quadrivalent Inactivated Influenza Vaccine Highlights & Side Effects. Trial Name: NCT04613206 — Phase 2
High Dose Quadrivalent Inactivated Influenza Vaccine (Virus Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04613206 — Phase 2
~0 spots leftby Dec 2024
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