Clinical trial for Immunization; Infection|Transplantation Infection|Influenza
Official title High vs. Standard Dose Influenza Vaccines in Lung Transplant (Repeater)
ClinicalTrials.gov ID: NCT07192458
What this study is testing
What is Fluzone High Dose Inactivated Influenza Vaccine?
Fluzone High Dose Inactivated Influenza Vaccine is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for immunization; infection|transplantation infection|influenza.
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
- This study checks if two doses of a high-dose flu vaccine create a stronger immune response than the standard dose. It also looks at how long that protection lasts over two years.
- Who it's for
- People who have already had a lung transplant and took part in a previous flu vaccine study.
- What's involved
- Participants will receive two flu shots each year for two seasons. They will have blood tests to check their immune response and report any side effects.
- Time commitment
- The study lasts for two years and requires regular visits to the clinic for shots and blood draws.
- 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 18 and older
You may be able to join if
- Lung transplant recipient who enrolled and completed Visits 1, 2, and 3 of the DMID protocol number 22-0014 during the prior 2024-2025 or 2025-2026...
- Anticipated to be available for the duration of the study
- Can be reached by telephone, text message, email, or electronic health record messaging
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 Guillain-Barre syndrome
- History of receiving the current season's influenza vaccine prior to study enrollment and/or Visit 1 of this follow-up study
- Pregnant person
- Laboratory-confirmed influenza disease after September 1st in the current influenza season and before enrollment in this follow-up study (patient can...
See the full eligibility criteria
- Lung transplant recipient who enrolled and completed Visits 1, 2, and 3 of the DMID protocol number 22-0014 during the prior 2024-2025 or 2025-2026 influenza season, respectively
- Anticipated to be available for the duration of the study
- Can be reached by telephone, text message, email, or electronic health record messaging
- Recipient of multi-organ, extra-pulmonary, and/or hematopoietic stem cell transplant
- Recipient of a re-do lung transplant
- History of Guillain-Barre syndrome
- History of receiving the current season's influenza vaccine prior to study enrollment and/or Visit 1 of this follow-up study
- Pregnant person
- Laboratory-confirmed influenza disease after September 1st in the current influenza season and before enrollment in this follow-up study (patient can still receive the second influenza vaccination despite proven...
- 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 vaccine dose (Day 0)
- Receipt of T-cell depleting therapies (anti-thymocyte globulin, alemtuzumab, daratumumab) between the completion of Visit 3 of the initial study and enrollment in this follow-up study
- Investigator concern about study participation
- Fever ≥100.4ºF/38.0ºC (oral measurement), or an acute severe illness within 48 hours of enrollment
- Receipt of any live vaccines within four weeks or any inactivated vaccines within two weeks prior to potential study vaccination No children have been enrolled in the DMID protocol number 22-0014
The study team makes the final eligibility decision.
Where it is enrolling
- 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, but 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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Nashville, Tennessee, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.