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Immunogenicity and safety of two respiratory syncytial virus vaccine strategies in lung and allogeneic haematopoietic stem cell transplant recipients: A phase 2 trial RSVaxID
EU CTIS ID: 2025-524374-42-00
What this study is testing
To evaluate the RSVpreF-binding antibody response to each of the two RSV vaccine strategies one month after completing vaccination, in two distinct subcohorts which will be separately analyzed: LTR and HSCTR
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Prior lung transplantation (including combined transplants) performed ≥3 months before the first vaccine administration (LTR) OR prior allogeneic haematopoietic stem cell transplantation performed within ≥3 months to 5 years before the first vaccine administration (HSCTR)
- active follow-up at one of the study centres
- age ≥18 years at inclusion
- providing written, informed consent
You likely can't join if
- Previous vaccination with any licensed or investigational RSV vaccine
- any person non affiliated to National French social security system or equivalent
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines
- Active malignant disease at inclusion (with the exclusion of non-melanoma skin cancer)
- Receipt of immunoglobulins and/or any plasma derivatives during the period starting 90 days before the first study vaccine administration, or planned administration during the study period
- Acute cellular graft rejection episode treated by corticosteroid boli within one month before first vaccine administration (LTR)
See the full eligibility criteria
- Prior lung transplantation (including combined transplants) performed ≥3 months before the first vaccine administration (LTR) OR prior allogeneic haematopoietic stem cell transplantation performed within ≥3 months to 5 years before the first vaccine administration (HSCTR)
- active follow-up at one of the study centres
- age ≥18 years at inclusion
- providing written, informed consent
- Previous vaccination with any licensed or investigational RSV vaccine
- any person non affiliated to National French social security system or equivalent
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines
- Active malignant disease at inclusion (with the exclusion of non-melanoma skin cancer)
- Receipt of immunoglobulins and/or any plasma derivatives during the period starting 90 days before the first study vaccine administration, or planned administration during the study period
- Acute cellular graft rejection episode treated by corticosteroid boli within one month before first vaccine administration (LTR)
- ongoing plasmapheresis for acute humoral graft rejection (LTR)
- ongoing, acute graft-versus-host disease of grade II/III/IV (HSCTR)
- Chronic graft-versus-host disease which is not stable for at least one month prior to first vaccine administration (HSCTR)
- anti-CD20 and/or anti-CD52 therapy within the last 6 months
- administration of anti-thymocyte globulin within the last 3 months;
- any vaccine administration within two weeks before inclusion or planned receipt within two weeks following each experimental vaccine administration
- known bleeding disorder which, in the opinion of the investigator, contraindicates intramuscular injection
- any female participant who is pregnant, lactating or planning to become pregnant during the study period. Female participants of childbearing potential may be enrolled if they have a negative pregnancy test on the day of each vaccine administration and must agree to continue adequate contraception during 12 weeks; (Contraception is considered effective when it consists of one of the following: use of a male condom during all sexual activity and/or efficient oral hormonal contraception (better considered combined contraception) and/or an intrauterine device and/or hormone-releasing intrauterine system and/or history of bilateral tubal ligation and/or history of vasectomy, provided the male partner is the trial participant's only sexual partner and/or sexual abstinence)
- expected unavailability for the planned study visits
- concurrent participation in another active clinical study at the time of inclusion which includes the application of investigational products (medication, vaccine) or an interventional research using an invasive medical device during the study period
- acute, severe febrile illness at the time of inclusion
- any person deprived of liberty by a judicial or administrative decision
- any person under legal protection measures
The study team makes the final eligibility decision.
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.