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Virus Vaccine

High vs Standard Dose Flu Vaccine for Lung Transplant Recipients

Phase 2
Recruiting
Led By Natasha Halasa, MD. MPH
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 (30 days) and <36 months post-lung transplant
Age ≥16 years at time of enrollment
Must not have
History of Guillain-Barre syndrome
History of receiving the current season's influenza vaccine post-transplant prior to enrollment in the study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 56 (post-vaccination)
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group

Summary

This trial will test if two doses of a high-dose influenza vaccine are more effective than two doses of a standard dose influenza vaccine in lung transplant recipients.

Who is the study for?
This trial is for lung transplant recipients aged 16 or older, who are between 1-35 months post-transplant. Participants must be reachable and available throughout the study. Exclusions include re-do transplants, multi-organ transplants, HIV positive individuals, severe latex allergy sufferers, recent recipients of certain immune therapies, pregnant women, those with egg allergies or a history of Guillain-Barre syndrome.
What is being tested?
The trial tests whether two doses of a High Dose (HD) influenza vaccine provide better protection than two doses of a Standard Dose (SD) vaccine in lung transplant patients. It's designed to see if higher antibody levels against flu result from the HD vaccine in these immunocompromised individuals.
What are the potential side effects?
Potential side effects may include typical reactions to flu vaccines such as soreness at injection site, headache, fever and muscle pain. Severe allergic reactions are rare but possible.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I had a lung transplant between 1 and 36 months ago.
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I am 16 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 had Guillain-Barre syndrome in the past.
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I have received this season's flu vaccine after my transplant.
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I have had more than one lung transplant.
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I have received a transplant that was not just for my lungs.

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

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Two Doses Standard Dose Quadrivalent Inactivated Influenza VaccineExperimental Treatment1 Intervention
receive two doses of SD-QIV (0.5 mL; 15µg of each influenza antigen) 28-42 days apart
Group II: Two Doses High Dose Quadrivalent Inactivated Influenza VaccineExperimental Treatment1 Intervention
two doses of HD-QIV (0.7 mL; 60µg of each influenza antigen) 28-42 days apart

Find a Location

Who is running the clinical trial?

Feinberg School of Medicine, Northwestern UniversityOTHER
33 Previous Clinical Trials
11,972 Total Patients Enrolled
Northwestern University Feinberg School of MedicineOTHER
41 Previous Clinical Trials
15,221 Total Patients Enrolled
Vanderbilt University Medical CenterLead Sponsor
907 Previous Clinical Trials
934,317 Total Patients Enrolled
University of WashingtonOTHER
1,829 Previous Clinical Trials
1,906,824 Total Patients Enrolled
Duke UniversityOTHER
2,462 Previous Clinical Trials
2,964,090 Total Patients Enrolled
University of Alabama at BirminghamOTHER
1,655 Previous Clinical Trials
2,443,843 Total Patients Enrolled
Natasha Halasa, MD. MPHPrincipal InvestigatorVanderbilt University Medical Center
1 Previous Clinical Trials
312 Total Patients Enrolled

Media Library

High Dose Quadrivalent Inactivated Influenza Vaccine (Virus Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT05215327 — Phase 2
Transplant Infection Research Study Groups: Two Doses Standard Dose Quadrivalent Inactivated Influenza Vaccine, Two Doses High Dose Quadrivalent Inactivated Influenza Vaccine
Transplant Infection Clinical Trial 2023: High Dose Quadrivalent Inactivated Influenza Vaccine Highlights & Side Effects. Trial Name: NCT05215327 — Phase 2
High Dose Quadrivalent Inactivated Influenza Vaccine (Virus Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05215327 — Phase 2
~149 spots leftby Jul 2027
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