Active — Not RecruitingPhase 3

RSV Vaccine in Transplant Recipients

Canada100 participantsStarted 2024-10-01

Plain-language 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. 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Humoral immunogenicity

Timeframe: 4 weeks after dose 1

Trial details

NCT IDNCT06593210

SponsorUniversity Health Network, Toronto

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-09

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