Seasonal Influenza Vaccine High Dose Boosting in Solid Organ Transplant Recipients (NCT05663463) | Clinical Trial Compass
CompletedNot Applicable
Seasonal Influenza Vaccine High Dose Boosting in Solid Organ Transplant Recipients
United States74 participantsStarted 2023-09-11
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* \>=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
* Able and willing to provide informed consent
* Able and willing to undergo all study activities throughout the duration of the study
Exclusion Criteria:
* Confirmed pregnancy
* Receipt of ATG or carfilzomib within the past 3 months
* Receipt of rituximab within the past 3 months
* Receipt of basiliximab within the past 3 months
* Prednisone dose \>= 20 mg/day at the time of enrollment
* History of a severe allergy to influenza vaccine (i.e. Guillain Barre syndrome, anaphylaxis or angioedema)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.