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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 56 (post-vaccination)
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I had a lung transplant between 1 and 36 months ago.
Select...
I am 16 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 56 (post-vaccination)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 56 (post-vaccination)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Geometric Mean Titers of influenza vaccine antibodies.
The number of participants reporting solicited injection site reactions and systemic reactions.
Secondary outcome measures
Geometric Mean Titers Ratio of influenza vaccine antibodies (post-/pre-vaccination).
The number of participants achieving seroprotection and seroconversion for influenza virus.
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
11,974 Total Patients Enrolled
1 Trials studying Infections
396 Patients Enrolled for Infections
Northwestern University Feinberg School of MedicineOTHER
38 Previous Clinical Trials
14,601 Total Patients Enrolled
1 Trials studying Infections
396 Patients Enrolled for Infections
Vanderbilt University Medical CenterLead Sponsor
856 Previous Clinical Trials
671,922 Total Patients Enrolled
14 Trials studying Infections
5,823 Patients Enrolled for Infections
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I had the flu after September 1st but before getting the study vaccine.People who have had a lung transplantI have had Guillain-Barre syndrome in the past.I haven't received T-cell depleting therapy in the last 3 months.I have not received CMVIG/IVIG/SCIG within 28 days before getting a vaccine.I had a lung transplant between 1 and 36 months ago.I have received this season's flu vaccine after my transplant.I have had more than one lung transplant.I am 16 years old or older.I can be contacted by phone, email, or text.I have received a transplant that was not just for my lungs.You have tested positive for HIV or have a history of HIV infection.You have a history of severe allergy to latex.I haven't received B-cell depleting therapy in the last 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: Two Doses Standard Dose Quadrivalent Inactivated Influenza Vaccine
- Group 2: Two Doses High Dose Quadrivalent Inactivated Influenza Vaccine
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are currently being monitored for this clinical experiment?
"Affirmative, the clinicaltrials.gov database shows that this research is actively seeking to enroll participants. The study was first advertised on November 7th 2022 and its details have been updated most recently on November 18th of the same year. 270 individuals are needed for completion at one single site."
Answered by AI
Are there still openings for participants to join this experiment?
"Affirmative. Clinicaltrials.gov data reveals that this study, first posted on November 7th 2022 is currently recruiting patients for enrollment. Approximately 270 subjects need to be enrolled from 1 particular medical centre."
Answered by AI
Is High Dose Quadrivalent Inactivated Influenza Vaccine a secure method of immunization for patients?
"Taking into consideration the Phase 2 status of this High Dose Quadrivalent Inactivated Influenza Vaccine, our team at Power assigned it a rating of two out of three for safety due to existing data on its precautionary properties but lack thereof regarding efficacy."
Answered by AI
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