Vaccine Response ImpairedPhase 3RSVaxNCT06593210
RSV Vaccine in Transplant Recipients
A Phase 3 study testing Adjuvant, non-live RSV vaccine in people with Vaccine Response Impaired and Respiratory Syncytial Virus Infections, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Adjuvant, non-live RSV vaccine will be administered to adult lung and allogeneic hematopoietic stem cell transplant recipients. The safety and immunogenicity of this intervention will be studied. Blood work will be collected before and after the intervention, to assess humoral and cellular immunity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vaccine Response Impaired, Respiratory Syncytial Virus Infections, Immune Suppression
- What is being tested?
- Adjuvant, non-live RSV vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 1 Oct 2024to Mar 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- Stable outpatient lung transplant recipients more than 3 months post-transplantation and stable outpatient allogeneic HCT recipients more than 6 months post-transplantation
- Adult equal or over 18 years of age
- Able to comply with blood work at 4-6 weeks post-vaccination
- Able to provide informed consent
Who cannot join
- Currently pregnant or planning to conceive or breastfeeding
- IVIg or plasmapharesis in last 30 days or expecting in next 30 days
- Previous rituximab in last 6 months
- Active CMV infection with VL > 1000 IU/ml
- Diagnosis of RSV in the past 90 days
- Unwell with acute infection (respiratory or other)
Show all 10Show fewer
- Any vaccination in last 2 weeks
- History of severe allergic reaction (anaphylaxis) to any vaccination
- Active rejection in last 30 days for lung transplant recipient
- Active GvHD or poor graft function for alloSCT recipient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Immunogenicity of Non-live, Adjuvanted Respiratory Syncytial Virus (RSV) Vaccine in Allogeneic Stem Cell Transplant and Lung Transplant Recipients
Adjuvant, non-live RSV vaccine will be administered to adult lung and allogeneic hematopoietic stem cell transplant recipients. The safety and immunogenicity of this intervention will be studied. Blood work will be collected before and after the intervention, to assess humoral and cellular immunity. Participants will be followed for adverse reaction, hospitalization, RSV breakthrough infection, graft rejection or graft versus host disease. This study has Health Canada and UHN REB approval.
Read the detailed description
This is a single-arm, open-label, investigational and interventional study to determine the immunogenicity of one dose of RSV vaccine in adult Allogeneic Stem Cell Transplant (alloSCT) or lung transplant (LT) recipients.Patients at least 18 years of age will receive a single dose of adjuvanted RSV vaccine (RSVPreF3, Arexvy, GSK). This vaccine is currently approved in Canada for adults over 60 years of age. Therefore, administration to adult transplant recipients between the age of 18 and 60 years of age is considered off-label. We have ethics approval to conduct this study from UHN and a No Objection Letter from Health Canada.
Study investigators (physicians) will perform the vaccination at hospital outpatient clinics.
Whole blood (total 30mL or 3 tubes) will be collected prior to vaccination and then at 4 weeks, 6 months, 12 months, 24 months and 36 months post-vaccination for humoral and cell-mediated immunity assessment. At each time point, 1 red-top blood tube (6mls) for serum and 2 green-top sodium heparin (9mls) blood tubes for plasma and peripheral blood mononuclear cells (PBMCs) will be collected.
Eligible patients will be screened as per the inclusion and exclusion criteria detailed in the screening log. After written informed consent and enrolment, the patient will be allocated a study code and data will be collected for demographics, including age, sex, gender identity, race, language spoken at home, immunosuppression at time of vaccination, time from transplant, immunosuppression regimen at time of transplant, underlying disease, recent lymphocyte count and immunoglobulin levels at the time of vaccination and follow up blood work. For alloSCT recipients, treatment history for Graft versus Host Disease (GvHD) and underlying disease status will be collected. For LT recipients, information regarding recent lung function and rejection episode(s) will be collected. Patients will be contacted at 6 weeks post-vaccination to determine the rates of adverse events including hospitalizations, cardiac, or neurologic events. Patients will then be contacted at 12, 24 and 36 months and interviewed to determine whether they had a diagnosis of RSV infection following vaccination. Total follow-up time for each patient will be 3 years from vaccination.
- Being tested
- Adjuvant, non-live RSV vaccine
- Medical subject headings
- Respiratory Syncytial Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adjuvant, non-live RSV vaccineBiological
Also called Arexvy
One dose of arexvy vaccine to transplant recipients.
| Study group | Role | What they receive |
|---|---|---|
| RSV vaccine group | Experimental | Single arm open label study of RSV vaccine to all adult transplant participants enrolling into the study. Receives: Biological: Adjuvant, non-live RSV vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Humoral immunogenicity
Neutralizing antibody response
Measured: 4 weeks after dose 1
Secondary outcomes (4)
Cellular immunogenicity
T cell immune response
Measured: 4 weeks after dose 1
Safety of the vaccine
Side effects after vaccine
Measured: 7 days after dose 1
Long-term safety
Hospitalization, adverse events, RSV breakthrough infection, GvHD, graft rejection
Measured: 3 years post dose 1
Durability of immunity
Humoral and cellular immunogenicity at 6, 12, 24 and 36 months post vaccination
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Oct 2024
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaccine Response ImpairedStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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 3
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- University of British Columbia, The Physicians' Services Incorporated Foundation
- Responsible party
- Principal investigator, Victoria Hall, University Health Network, Toronto
- Investigators
- Victoria G Hall, MBBS, Principal investigator, UHN Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06593210
- Sponsor's protocol ID
- 24-5021
- Acronym
- RSVax
- Status last verified
- Oct 2026
- First submitted
- 9 Sep 2024
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Immunogenicity of Non-live, Adjuvanted Respiratory Syncytial Virus (RSV) Vaccine in Allogeneic Stem Cell Transplant and Lung Transplant Recipients
- ClinicalTrials.gov ID
- NCT06593210
- Acronym / sponsor ID
- RSVax / 24-5021
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- University of British Columbia, The Physicians' Services Incorporated Foundation
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Adjuvant, non-live RSV vaccine will be administered to adult lung and allogeneic hematopoietic stem cell transplant recipients. The safety and immunogenicity of this intervention will be studied. Blood work will be collected before and after the intervention, to assess humoral and cellular immunity. Participants will be followed for adverse reaction, hospitalization, RSV breakthrough infection, graft rejection or graft versus host disease. This study has Health Canada and UHN REB approval.
Detailed description
This is a single-arm, open-label, investigational and interventional study to determine the immunogenicity of one dose of RSV vaccine in adult Allogeneic Stem Cell Transplant (alloSCT) or lung transplant (LT) recipients.Patients at least 18 years of age will receive a single dose of adjuvanted RSV vaccine (RSVPreF3, Arexvy, GSK). This vaccine is currently approved in Canada for adults over 60 years of age. Therefore, administration to adult transplant recipients between the age of 18 and 60 years of age is considered off-label. We have ethics approval to conduct this study from UHN and a No Objection Letter from Health Canada.
Study investigators (physicians) will perform the vaccination at hospital outpatient clinics.
Whole blood (total 30mL or 3 tubes) will be collected prior to vaccination and then at 4 weeks, 6 months, 12 months, 24 months and 36 months post-vaccination for humoral and cell-mediated immunity assessment. At each time point, 1 red-top blood tube (6mls) for serum and 2 green-top sodium heparin (9mls) blood tubes for plasma and peripheral blood mononuclear cells (PBMCs) will be collected.
Eligible patients will be screened as per the inclusion and exclusion criteria detailed in the screening log. After written informed consent and enrolment, the patient will be allocated a study code and data will be collected for demographics, including age, sex, gender identity, race, language spoken at home, immunosuppression at time of vaccination, time from transplant, immunosuppression regimen at time of transplant, underlying disease, recent lymphocyte count and immunoglobulin levels at the time of vaccination and follow up blood work. For alloSCT recipients, treatment history for Graft versus Host Disease (GvHD) and underlying disease status will be collected. For LT recipients, information regarding recent lung function and rejection episode(s) will be collected. Patients will be contacted at 6 weeks post-vaccination to determine the rates of adverse events including hospitalizations, cardiac, or neurologic events. Patients will then be contacted at 12, 24 and 36 months and interviewed to determine whether they had a diagnosis of RSV infection following vaccination. Total follow-up time for each patient will be 3 years from vaccination.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RSV vaccine group | Experimental | Biological: Adjuvant, non-live RSV vaccineSingle arm open label study of RSV vaccine to all adult transplant participants enrolling into the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Stable outpatient lung transplant recipients more than 3 months post-transplantation and stable outpatient allogeneic HCT recipients more than 6 months post-transplantation
- Adult equal or over 18 years of age
- Able to comply with blood work at 4-6 weeks post-vaccination
- Able to provide informed consent
Key exclusion criteria (10 listed)
- Currently pregnant or planning to conceive or breastfeeding
- IVIg or plasmapharesis in last 30 days or expecting in next 30 days
- Previous rituximab in last 6 months
- Active CMV infection with VL > 1000 IU/ml
- Diagnosis of RSV in the past 90 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adjuvant, non-live RSV vaccineAlso: ArexvyOne dose of arexvy vaccine to transplant recipients. | Biological | RSV vaccine group |
Primary outcome
Humoral immunogenicity
Time frame: 4 weeks after dose 1
Neutralizing antibody response
4 secondary outcomes
Cellular immunogenicity
Time frame: 4 weeks after dose 1
Safety of the vaccine
Time frame: 7 days after dose 1
Long-term safety
Time frame: 3 years post dose 1
Durability of immunity
Time frame: 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Victoria G Hall, MBBS principal investigator
UHN Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Adjuvant, non-live RSV vaccine in people with Vaccine Response Impaired and Respiratory Syncytial Virus Infections, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Humoral immunogenicity (time frame: 4 weeks after dose 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.