Immunocompromised PatientsPhase 2RSVAxIDNCT07863401
Immunogenicity and Safety of Two Respiratory Syncytial Virus Vaccine Strategies in Lung and Allogeneic Haematopoietic Stem Cell Transplant Recipients.
A Phase 2 study testing RSVpreF3-AS01 and RSVpreF3 in people with Immunocompromised Patients, run by Hospices Civils de Lyon at 16 sites in France.
Trial summary
Respiratory syncytial virus (RSV) is a major cause of acute respiratory infections (ARIs), which occur in seasonal outbreaks. Among the adult population, immunocompromised individuals, particularly lung transplant recipients and recipients of allogeneic haematopoietic stem cell transplants (HSCTs), are at the highest… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Immunocompromised Patients
- What is being tested?
- RSVpreF3-AS01 and RSVpreF3
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 16 sitesFrance
- Study dates
- Oct 2026to May 2029
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Previous vaccination with any licensed or investigational RSV vaccine;
- 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);
Show all 19Show fewer
- 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.
- 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;
- Any person non affiliated to National French social security system or equivalent.
Trial locations and contacts
16 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Fanny JOUBERT contact
16 sites in 1 country
France16 sites
Hospices Civils de Lyon - Hopital Louis Pradel - Service de Pneumologie
Bron, 69677
Claire MERVEILLEUX, claire.merveilleux@chu-lyon.fr
APHP Henri Mondor - Service d'Hématologie
Créteil
Christine ROBIN, christine.robin@aphp.fr
Christine ROBIN
GH Saint Joseph - Hopital Lannelongue - Service de Pneumologie
Le Plessis-Robinson
Jérome LE PAVEC, j.lepavec@ghpsj.fr
Hospices CIvils de Lyon - Hopital de la Croix Rousse - Service MIT
Lyon, 69004
Anne CONRAD, +33 4 72 01 77 07, anne.conrad@chu-lyon.fr
Anne CONRAD
APHM - Hôpital Nord / Pneumologie
Marseille
Benjamin COIFFARD, benjamin.coiffard@ap-hp.fr
CHU Nantes - Hotel Dieu
Nantes
Amandine LE BOURGEOIS, Amandine.lebourgeois@chu-nantes.fr
Amandine Le Bourgeois
CHU Nantes - Hôpital Laennec - Pneumologie
Nantes
Adrien TISSOT
adrien.tissot@chu-nantes.fr
APHP Hopital Bichat - Service de pneumologie
Paris
Tiphaine GOLETTO, Tiphaine.goletto@aphp.fr
APHP Saint Louis - Service d'Hématologie
Paris
Aliénor XHAARD, alienor.xhaard@aphp.fr
CHU Bordeaux - Hopital Haut Lévèque
Pessac
Elodie BLANCHARD, elodie.blanchard@chu-bordeaux.fr
CHU St Etienne - Hopital Nord - Service d'Hématologie
Saint-Etienne
Jérome CORNILLON, jerome.cornillon@chu-st-etienne.fr
CHU Strasbourg - Hopital Hautepierre - Service d'Hématologie
Strasbourg
Marie-Pierre LEDOUX, mp.ledoux@icans.eu
CHU Strasbourg - Nouvel Hopital Civil - Service de Pneumologie
Strasbourg
Benjamin RENAUD-PICARD, benjamin.renaudpicard@chru-strasbourg.fr
Hôpital Foch
Suresnes
Clément PICARD, c.picard@hopital-foch.com
Clément PICARD
CHU Toulouse - Hopital Larrey - Service de Pneumologie
Toulouse
Jean MOURLANETTE, mourlanette.j@chu-toulouse.fr
CHU Toulouse - Oncopole - Service Hématologie
Toulouse
Anne HUYHN, huynh.anne@iuct-oncopole.fr
About this study
Official title: Immunogenicity and Safety of Two Respiratory Syncytial Virus Vaccine Strategies in Lung and Allogeneic Haematopoietic Stem Cell Transplant Recipients: A Phase 2 Trial
Respiratory syncytial virus (RSV) is a major cause of acute respiratory infections (ARIs), which occur in seasonal outbreaks. Among the adult population, immunocompromised individuals, particularly lung transplant recipients and recipients of allogeneic haematopoietic stem cell transplants (HSCTs), are at the highest risk of severe ARI. RSV can also cause prolonged inflammation of the airways, leading to persistent deterioration in lung function. Thus, in lung transplant recipients, RSV is a major cause of chronic lung allograft dysfunction (CLAD), the leading cause of lung transplant failure and mortality beyond the first post-transplant year. In recipients of ACSH, RSV infection is associated with the onset and/or worsening of bronchiolitis obliterans syndrome, which leads to increased mortality. Preventing RSV-associated lower respiratory tract disease (LRTD) and its short- and long-term consequences in these populations is therefore a key priority.
Three inactivated RSV vaccines, targeting the RSV fusion glycoprotein in its pre-fusion conformation (RSVpreF), have recently been approved for use in adults. These comprise two recombinant protein vaccines - one with an adjuvant (RSVpreF3-AS01, Arexvy®, GSK) and one without (RSVpreF, Abrysvo®, Pfizer) - and one mRNA vaccine. Although these vaccines have demonstrated their safety, immunogenicity and efficacy (reducing the risk of RSV-related IMRI by approximately 80-85 per cent) in adults aged 60 and over, the pivotal trials excluded immunocompromised patients.
Read more
To date, there is limited data on the efficacy, immunogenicity and tolerability of these vaccines in high-risk immunocompromised populations, such as recipients of bone marrow transplants and allogeneic stem cell transplants. Real-world studies suggest that RSV vaccines may reduce the risk of RSV-associated acute respiratory infection and hospitalisations in elderly immunocompromised adults. With regard to immunogenicity, the available cohort studies, conducted on small sample sizes, indicate that the vaccine response is heterogeneous and, overall, lower than that observed in immunocompetent older people. Preliminary data suggest that booster vaccination regimens may be necessary to optimise the immune response in these populations.
Given the significant morbidity associated with RSV in recipients of bone marrow transplants and allogeneic stem cell transplants, it is a priority to assess the immunogenicity and safety profile of RSV vaccines, and to determine the optimal vaccination schedule for these high-risk, immunocompromised populations.
The investigators hypothesise that the immune response to RSV vaccines in severely immunocompromised TP and ACSH recipients is weaker than in immunocompetent older adults, and that enhanced vaccination strategies may be required. In this study, two vaccination strategies will be evaluated in these populations:
- a single dose of the adjuvanted RSVpreF3-AS01 vaccine (Arexvy®),
- or a booster regimen comprising two doses of the non-adjuvanted RSVpreF vaccine (Abrysvo®), administered one month apart.
- Conditions
- Immunocompromised Patients
- Being tested
- RSVpreF3-AS01, RSVpreF3
- Keywords
- immunocompromised patients, RSV, Vaccines, allograft recipients, lunf transplant recipients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RSVpreF3-AS01Biological
Administration of a single 0.5 mL dose on day 0 (D0) by intramuscular injection
RSVpreF3Biological
Administration of a 0.5 mL dose on day 0 (D0) and a 0.5 mL dose on day 30 by intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| Recipients of lung transplants (LTR) | Experimental | A history of lung transplantation performed ≥ 3 months ago, and eligible for RSV vaccination (RSVpreF3-AS01 or RSVpreF) via intramuscular injection Receives: Biological: RSVpreF3-AS01; Biological: RSVpreF3 |
| Recipients of haematopoietic stem cell transplants (HSCTR) | Experimental | A history of haematopoietic stem cell allograft performed between ≥3 months and 5 years ago, who are eligible to receive an RSV vaccine (RSVpreF3-AS01 or RSVpreF) by intramuscular injection Receives: Biological: RSVpreF3-AS01; Biological: RSVpreF3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
RSVpreF-binding antibody response to each of the two RSV vaccine strategies in two distinct subcohorts (LTR and HSCTR)
Proportion of participants in each group who achieve a seroresponse one month after completion of vaccination (visit 2). A seroresponse is defined as either (1) seroconversion, i.e., an RSVpreF-binding serum IgG concentration ≥4 times the lower limit of quantification (LLOQ) when baseline is <LLOQ, or (2) a ≥4-fold rise in RSVpreF-binding serum IgG concentration from baseline
Measured: One month after completing vaccination (Visit 2 - Day 30 for patients with RSVpreF3-AS01 or Day 60 for patients with RSVApreF3)
Secondary outcomes (24)
RSV-A/RSV-B neutralizing antibody response for each vaccine strategy one month after completing vaccination
To assess and compare the RSV-A and RSV-B serum 50% neutralizing geometric mean titres (GMT) and corresponding neutralizing titre geometric mean fold rises (GMFR), measured by an RSV neutralization assay to each vaccine strategy
Measured: Baseline (Visit 1 - Day 0) ; one month after completing vaccination (Visit 2 - Day 30 for patients with RSVpreF3-AS01 or Day 60 for patients with RSVApreF3))
Systemic humoral immune response for each vaccine strategy and its persistence up to one year post-vaccination
To characterize and compare proportion of participants in each group achieving a ≥2-fold rise in RSVpreF-binding serum IgG between baseline and visit 2, as measured by standard EIA; Log (serum dilution) for 50% signal inhibition in D25- and palivizumab-competitive EIA to each vaccine strategy
Measured: Baseline (Visit 1 - Day 0), pre-dose-2 (only RSVpreF arm, visit 1b - Day 30), visit 2 (Day 30 for patients with RSVpreF3-AS01 or Day 60 for patients with RSVApreF3)) and one-year after first vaccine dose (visit 3 - Year 1)
Reactogenicity and safety of each vaccine strategy
To determine and compare for each vaccine strategy:
- Frequency, type and severity of local and systemic solicited adverse events within 7 days following each vaccine administration;
- frequency, type and severity of unsolicited adverse events within 30 days following each vaccine administration; severe adverse events and adverse events of special interest until the end of study
Measured: 7 days following each vaccine administration (Day 7 for all patients and day 37 for patients with RSVApreF3) and 30 days following each vaccine administration respectively (Day 30 for all patients and day 60 for patients with RSVApreF3)
Mucosal (oral fluid) humoral immune response to each vaccine strategy one month after completing vaccination
To determine and compare the Geometric mean titres (GMT) and corresponding geometric mean fold rises (GMFR) of RSVpreF-binding oral fluid IgA, measured by EIA in oral fluid for each vaccine strategy
Measured: Baseline (day 0), visit 2 (Day 30 for patients with RSVpreF3-AS01 or Day 60 for patients with RSVApreF3)
Determinants of humoral immune response: Age
Analysis of determinants of humoral immunogenicity to each vaccine strategy: age, time from transplantation, acute rejection episode(s) before and during the study period (in LTR), type of induction immunosuppression (in LTR), ongoing immunosuppressive treatment at the time of vaccination, stem cell source (in HSCTR), type of donor (in HSCTR), acute/chronic GVHD before and during the study period (in HSCTR), ongoing immunosuppressive treatment at the time of vaccination
Measured: Baseline (day 0)
Determinants of humoral immune response: time from transplantation
Analysis of determinants of humoral immunogenicity to each vaccine strategy: age, time from transplantation, acute rejection episode(s) before and during the study period, type of induction immunosuppression, ongoing immunosuppressive treatment at the time of vaccination (in LTR); age, time from transplantation, stem cell source, type of donor, acute/chronic GVHD before and during the study period, ongoing immunosuppressive treatment at the time of vaccination (in HSCTR)
Measured: Baseline (day 0)
Determinants of humoral immune response: acute rejection episode(s) before and during the study period
In Lung Transplantation patients Analysis of determinants of humoral immunogenicity to each vaccine strategy: age, time from transplantation, acute rejection episode(s) before and during the study period, type of induction immunosuppression, ongoing immunosuppressive treatment at the time of vaccination (in LTR); age, time from transplantation, stem cell source, type of donor, acute/chronic GVHD before and during the study period, ongoing immunosuppressive treatment at the time of vaccination (in HSCTR)
Measured: Visit 3 (1 year)
Determinants of humoral immune response: type of induction immunosuppression
In Lung Transplantation patients Analysis of determinants of humoral immunogenicity to each vaccine strategy: age, time from transplantation, acute rejection episode(s) before and during the study period, type of induction immunosuppression, ongoing immunosuppressive treatment at the time of vaccination (in LTR); age, time from transplantation, stem cell source, type of donor, acute/chronic GVHD before and during the study period, ongoing immunosuppressive treatment at the time of vaccination (in HSCTR)
Measured: Baseline (day 0)
Determinants of humoral immune response: ongoing immunosuppressive treatment at the time of vaccination
Analysis of determinants of humoral immunogenicity to each vaccine strategy: age, time from transplantation, acute rejection episode(s) before and during the study period, type of induction immunosuppression, ongoing immunosuppressive treatment at the time of vaccination (in LTR); age, time from transplantation, stem cell source, type of donor, acute/chronic GVHD before and during the study period, ongoing immunosuppressive treatment at the time of vaccination (in HSCTR)
Measured: Baseline (day 0), visit 1b (day 30)
Determinants of humoral immune response: stem cell source
in HSCTR patients Analysis of determinants of humoral immunogenicity to each vaccine strategy: age, time from transplantation, acute rejection episode(s) before and during the study period, type of induction immunosuppression, ongoing immunosuppressive treatment at the time of vaccination (in LTR); age, time from transplantation, stem cell source, type of donor, acute/chronic GVHD before and during the study period, ongoing immunosuppressive treatment at the time of vaccination (in HSCTR)
Measured: Baseline (day 0)
Determinants of humoral immune response: type of donor
in HSCTR patients Analysis of determinants of humoral immunogenicity to each vaccine strategy: age, time from transplantation, acute rejection episode(s) before and during the study period, type of induction immunosuppression, ongoing immunosuppressive treatment at the time of vaccination (in LTR); age, time from transplantation, stem cell source, type of donor, acute/chronic GVHD before and during the study period, ongoing immunosuppressive treatment at the time of vaccination (in HSCTR)
Measured: Baseline (day 0)
Determinants of humoral immune response: acute/chronic GVHD before and during the study period
in HSCTR patients Analysis of determinants of humoral immunogenicity to each vaccine strategy: age, time from transplantation, acute rejection episode(s) before and during the study period, type of induction immunosuppression, ongoing immunosuppressive treatment at the time of vaccination (in LTR); age, time from transplantation, stem cell source, type of donor, acute/chronic GVHD before and during the study period, ongoing immunosuppressive treatment at the time of vaccination (in HSCTR)
Measured: Baseline (day 0), visit 1b (day 30)
Overall survival for patients with medical attented RSV episodes (RT-PCR confirmed)
To describe frequency and severity (overall survival, need for hospitalization, ICU hospitalization, type of treatment, respiratory deterioration [in LTR only] until the end of study) of RT-PCR confirmed
Measured: Visit 3 - Year 1
Need for hospitalization for patients with medical attented RSV episodes (RT-PCR confirmed)
To describe frequency and severity (overall survival, need for hospitalization, ICU hospitalization, type of treatment, respiratory deterioration [in LTR only] until the end of study) of RT-PCR confirmed
Measured: Visit 3 - Year 1
ICU hospitalization for patients with medical attented RSV episodes (RT-PCR confirmed)
To describe frequency and severity (overall survival, need for hospitalization, ICU hospitalization, type of treatment, respiratory deterioration [in LTR only] until the end of study) of RT-PCR confirmed
Measured: Visit 3 - Year 1
Type of treatment for patients with medical attented RSV episodes (RT-PCR confirmed)
To describe frequency and severity (overall survival, need for hospitalization, ICU hospitalization, type of treatment, respiratory deterioration [in LTR only] until the end of study) of RT-PCR confirmed
Measured: Visit 3 - Year 1
Respiratory deterioration for LTR patients with medical attented RSV episodes (RT-PCR confirmed)
To describe frequency and severity (overall survival, need for hospitalization, ICU hospitalization, type of treatment, respiratory deterioration [in LTR only] until the end of study) of RT-PCR confirmed
Measured: Visit 3 - Year 1
To characterize RSV isolates from medically attended RSV infection episodes occurring in vaccinated participants
Full-length genome sequencing and sequence analysis of any clinical RSV isolate
Measured: At the time of medically attended RSV infection
Geometric mean concentrations (GMC) of RSVpreF-binding serum IgG in vaccinated patients
Systemic and mucosal humoral immune response to each vaccine strategy at the time of medically attended RSV infection episodes occurring in vaccinated participants: Geometric mean concentrations (GMC) of RSVpreF-binding serum IgG, geometric mean titres (GMT) of RSV-A/RSV-B serum neutralizing antibodies (NAbs) and GMT of RSVpreF-binding oral fluid IgA
Measured: Visit 3 - Year 1
Geometric mean titres (GMT) of RSV-A/RSV-B serum neutralizing antibodies (NAbs) in vaccinated participants
Systemic and mucosal humoral immune response to each vaccine strategy at the time of medically attended RSV infection episodes occurring in vaccinated participants: Geometric mean concentrations (GMC) of RSVpreF-binding serum IgG, geometric mean titres (GMT) of RSV-A/RSV-B serum neutralizing antibodies (NAbs) and GMT of RSVpreF-binding oral fluid IgA
Measured: Visit 3 - Year 1
GMT of RSVpreF-binding oral fluid IgA in vaccinated participants
Systemic and mucosal humoral immune response to each vaccine strategy at the time of medically attended RSV infection episodes occurring in vaccinated participants: Geometric mean concentrations (GMC) of RSVpreF-binding serum IgG, geometric mean titres (GMT) of RSV-A/RSV-B serum neutralizing antibodies (NAbs) and GMT of RSVpreF-binding oral fluid IgA
Measured: Visit 3 - Year 1
Geometric mean concentrations (GMC) of RSVpreF-binding serum IgG
In participants with medically attended RSV infection episodes and in matched participants without medically attended RSV infection episodes.
Matching criteria: age, time from transplantation, type of transplantation [LTR or HSCTR], type of vaccine strategy
Measured: Visit 2 (Day 30 for patients with RSVpreF3-AS01 or Day 60 for patients with RSVApreF3)
Geometric mean titres (GMT) of RSV-A/RSV-B serum neutralizing antibodies (NAbs)
In participants with medically attended RSV infection episodes and in matched participants without medically attended RSV infection episodes.
Matching criteria: age, time from transplantation, type of transplantation [LTR or HSCTR], type of vaccine strategy
Measured: Visit 2 (Day 30 for patients with RSVpreF3-AS01 or Day 60 for patients with RSVApreF3)
GMT of RSVpreF-binding oral fluid IgA
In participants with medically attended RSV infection episodes and in matched participants without medically attended RSV infection episodes.
Matching criteria: age, time from transplantation, type of transplantation [LTR or HSCTR], type of vaccine strategy
Measured: Visit 2 (Day 30 for patients with RSVpreF3-AS01 or Day 60 for patients with RSVApreF3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immunocompromised PatientsStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A multicenter, randomised in 2-parallel group, open-label study
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07863401
- Sponsor's protocol ID
- 69HCL25_0854
- Other IDs
- 2025-524374-42-00, 2025
- Acronym
- RSVAxID
- Status last verified
- Oct 2026
- First submitted
- 2 Oct 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided