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New RSV vaccine trial aims to protect vulnerable transplant recipients

NCT ID NCT06593210

Vaccine Sponsor: University Health Network, Toronto Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial is testing a non-live, adjuvanted RSV vaccine (Arexvy) in 100 adults who have received a lung or stem cell transplant. The goal is to see if the vaccine is safe and helps their immune system fight RSV, a common virus that can be dangerous for them. Participants will have blood tests before and after vaccination to measure immune response, and will be monitored for side effects, infections, and transplant complications.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Arexvy (non-live, adjuvanted RSV vaccine)
What this could lead to
If successful, this could provide a safe and effective RSV vaccine for people with weakened immune systems after transplants, reducing serious infections.
What could go wrong
This is a relatively small, early-phase study (100 participants) and transplant recipients have suppressed immune systems, so the vaccine may not produce a strong immune response or could cause unexpected side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2024

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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) * 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

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Conditions

The condition(s) this trial relates to.

respiratory syncytial virus infectious disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Immune suppression Respiratory syncytial virus infections Vaccine response impaired

Contacts and locations

Locations

  • University Health Network

    Toronto, Canada

More trials for these conditions

Other studies related to the condition(s) this trial covers.