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A Phase II randomized trial of RSV vaccination in allogeneic hematopoietic stem cell transplant recipients (RSV-Allo study)
EU CTIS ID: 2024-513290-53-00
What this study is testing
The two main aims of the study are: - 1) A 2-center phase II trial of anti-RSV vaccination in allo-HSCT recipients. Eligible patients will be first randomized to be part of the RSVPreF (Abrysvo) or the RSVPreF3 OA (Arexvy) arm of the trial, unless one of the two vaccine arms is closed. The design of each vaccine arm are Simon’s two-stage phase II trials (see section 9). Specifically, in each arm, sixteen patients will receive one single i.m. injection of the vaccine (first cohort). If 11 or more of the 16 evaluable patients (i.e. patients with day 28 sampling) achieve a seroconversion (> 5-fold increase in levels of RSV F binding IgG between day 0 (day of vaccine administration) and day 28), 25 additional patients will receive a single injection of the vaccine for a total of 41 evaluable patients. If ten or less of the 16 patients (first stage) or if 29 or less of the 41 patients (second stage) achieve a seroconversion, a second cohort of sixteen patients will receive two injections of the vaccine at 8-10 weeks apart. If 11 or more patients of the second cohort achieve a seroconversion, 25 additional patients will receive two injections of the vaccine at 8 weeks apart for a total of 41 patients for the second cohort (and 57 (if only the first stage was performed in the first cohort) or 82 (if the first and second stages were performed in the first cohort) eligible patients in total). If ten or less of the 16 patients from the first stage of second cohort achieve a seroconversion, the study will be closed for futility after a total of 32 or 57 eligible patients for each vaccine arm. So, according to the observed seroconversion rate, from 64 to 164 eligible patients will be included in the trial. - 2) A systems biology study aimed at 1) defining a baseline signature predicting response to the vaccine; 2) assessing the impact of one or more dose of the RSV vaccine on the immune system; and 3) at comparing the immune signature of the RSVPreF (Abrysvo) or the RSVPreF3 OA (Arexvy) vaccine. This systems vaccinology study will be performed on samples collected during the phase II study described above as well as in a cohort of 40 healthy control subjects aged 60 years or more who will be randomized 1/1 to receive the RSVPreF (Abrysvo) or the RSVPreF3 OA (Arexvy) vaccine. The signature of each in allo-HSCT and in healthy controls will also be compared.
- Phase II and Phase III (Integrated)
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 allo-HSCT 3 months to 5 years before first vaccination (any donor type except cord blood transplantation); patients > 5 years are also eligible if they are still on systemic immunosuppressive treatment for chronic GVHD
- Age > or = 18 years at inclusion
- Written informed consent
You likely can't join if
- Known HIV seropositivity
- Previous vaccination with any licensed or investigational RSV vaccine or planned receipt during study participation
- Active malignant disease at vaccination
- Current grade III-IV acute GVHD
- Ongoing transplant-associated thrombotic microangiopathy (TA-TMA)
- In vitro T-cell depletion of the graft if vaccination within 6 months after transplantation
See the full eligibility criteria
- Prior allo-HSCT 3 months to 5 years before first vaccination (any donor type except cord blood transplantation); patients > 5 years are also eligible if they are still on systemic immunosuppressive treatment for chronic GVHD
- Age > or = 18 years at inclusion
- Written informed consent
- Known HIV seropositivity
- Previous vaccination with any licensed or investigational RSV vaccine or planned receipt during study participation
- Active malignant disease at vaccination
- Current grade III-IV acute GVHD
- Ongoing transplant-associated thrombotic microangiopathy (TA-TMA)
- In vitro T-cell depletion of the graft if vaccination within 6 months after transplantation
- Rituximab administration < 6 months before inclusion
- IVIg in the 30 days before vaccination or planned IVIg administration in the 28 days after the last vaccine administration
- History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s) or any related vaccine
- Individuals with known bleeding disorder that would, in the opinion of the investigator, contraindicate intramuscular or subcutaneous injection
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.