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The investigators plan to study the immunogenicity of the vaccine before and after lung transplantation. Patients (at least 50 years old) before and after lung transplantation will be enrolled. The investigators hypothesize that the recombinant varicella-zoster subunit vaccine is able to induce cellular immunogenicity after transplantation.
Solid organ transplant recipients receive lifelong immunosuppression and are at increased risk for reactivation of all herpesviruses including VZV. Epidemiologic studies show the cumulative incidence in lung transplant recipients of reactivation to be 15-20%. A non-live, recombinant subunit vaccine (Shingrix; GSK vaccines) was recently licensed for the prevention of shingles in people aged 50 years or older. The investigators plan to study the immunogenicity of the vaccine before and after lung transplantation. Patients (at least 50 years old) before and after lung transplantation will be enrolled. The investigators hypothesize that the recombinant varicella-zoster subunit vaccine is able to induce cellular immunogenicity after transplantation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pre-Transplant Group | Active Comparator | VZV Subunit vaccine will be administered |
|
| Post-Transplant Group | Experimental | VZV Subunit vaccine will be administered |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VZV subunit vaccine | Biological | VZV subunit vaccine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cellular immunity to varicella zoster induced by varicella zoster subunit vaccine. | Cellular immunogenicity against VZV induced by varicella zoster subunit vaccine in lung transplant recipients measured as a percentage of CD4+ and CD8+ T-cells measured by intracellular flow-cytometry based staining. The cellular immunogenicity of the vaccine in lung transplant recipients will be compared to the control group (pre-transplant vaccination). | 4 weeks after second dose of vaccine |
| Measure | Description | Time Frame |
|---|---|---|
| Humoral immunogenicity to varicella zoster induced by varicella zoster subunit vaccine in lung transplant recipients. | Humoral immunogenicity (increase of GMTs of anti-VZV antibodies) in lung transplant | 4 weeks after second dose of vaccine |
| Humoral immunogenicity to varicella zoster induced by varicella zoster subunit vaccine in post-transplant group vs. pre-transplant group |
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Inclusion Criteria Post-Transplant Vaccine Group:
Exclusion Criteria Post-Transplant Vaccine Group:
Inclusion Criteria Pre-Transplant Vaccine Group:
Exclusion Criteria Pre-Transplant Vaccine Group:
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| Name | Affiliation | Role |
|---|---|---|
| Deepali Kumar, MD | Multi organ transplant program, University Health Network, Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Health Network, Toronto General Hospital, Multi-Organ Transplant | Toronto | Ontario | M5G2N2 | Canada |
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Humoral immunogenicity (GMTs of anti-VZV antibodies compared pre and post vaccination) against VZV induced by varicella zoster subunit vaccine in lung transplant recipients compared to the pre-transplant control group. |
| 4 weeks after second dose of vaccine |