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New treatment option for Immunization; Infection
Official title High vs. Standard Dose Influenza Vaccine in Lung Allograft Recipients
ClinicalTrials.gov ID: NCT05215327
What this study is testing
What is High Dose Quadrivalent Inactivated Influenza Vaccine?
High Dose Quadrivalent Inactivated Influenza Vaccine is an investigational medicine, given as an once-weekly injection into a muscle, being studied as a potential treatment for immunization; infection.
Also referred to as Fluzone High Dose.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Lung allograft recipients have a higher burden of influenza disease and greater associated morbidity and mortality compared with healthy controls. Induction and early maintenance immunosuppression is thought to impair immunogenicity to standard dose inactivated influenza vaccine.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 16 and older
You may be able to join if
- Lung allograft recipients
- Age ≥16 years at time of enrollment
- ≥1 month (30 days) and \<36 months post-lung transplant
- Anticipated to be available for duration of the study
- Can be reached by telephone, email, or text message
You likely can't join if
- Recipient of multi-organ, extra-pulmonary, and/or hematopoietic stem cell transplant
- Recipient of a re-do lung transplant
- History of severe hypersensitivity to previous influenza vaccination or anaphylaxis to eggs/egg protein
- History of Guillain-Barre syndrome
- HIV positive patients, by history or documentation from previous test
- History of known severe latex hypersensitivity
See the full eligibility criteria
- Lung allograft recipients
- Age ≥16 years at time of enrollment
- ≥1 month (30 days) and \<36 months post-lung transplant
- Anticipated to be available for duration of the study
- Can be reached by telephone, email, or text message
- Recipient of multi-organ, extra-pulmonary, and/or hematopoietic stem cell transplant
- Recipient of a re-do lung transplant
- History of severe hypersensitivity to previous influenza vaccination or anaphylaxis to eggs/egg protein
- History of Guillain-Barre syndrome
- HIV positive patients, by history or documentation from previous test
- History of known severe latex hypersensitivity
- History of receiving the current season's influenza vaccine post-transplant prior to enrollment in the study
- Pregnant female
- Proven influenza disease after September 1st and before first study vaccine (patient can still receive the second influenza vaccination despite proven influenza disease once enrolled)
- CMVIG/IVIG/SCIG receipt within 28 days of each vaccine
- Receipt of rituximab or other B-cell depleting antibody (including proteasome inhibitors) therapy within 3-months of 1st study vaccine (Day 0).
- Receipt of augmented T-cell depleting therapy within 3-months of 1st study vaccine (Day 0)
- Investigator concern about study participation
The study team makes the final eligibility decision.
Where it's taking place
- Nashville, Tennessee, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 16 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nashville, Tennessee, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.