Safety and Immunogenicity of Non-live, Recombinant Subunit Herpes Zoster Vaccine Before and After Lung Transplantation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Safety and Immunogenicity of Non-live, Recombinant Subunit Herpes Zoster Vaccine Before and After Lung Transplantation

Conditions
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Varicella Zoster Vaccine

Intervention / Treatment
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* Biological: VZV subunit vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Post-Transplant Vaccine Group: Single or double lung transplant recipient. Age ≥50 years Exclusion Criteria Post-Transplant Vaccine Group: Has already received varicella zoster subunit vaccine in the past Shingles within the last 12 months Ongoing CMV viremia > 200 IU/mL HIV infection Diagnosis of malignancy (eg PTLD) Inclusion Criteria Pre-Transplant Vaccine Group: On waiting list for lung transplantation Age ≥50 years Exclusion Criteria Pre-Transplant Vaccine Group: Has already received Shingrix or Zostavax (live shingles vaccine) in the past Systemic prednisone ≥20 mg per day (or equivalent dose of any corticosteroid) Other (than prednisone < 20mg per day or equivalent dose of any corticosteroid) systemic immunosuppressive therapy such as mycophenolate or tacrolimus Shingles within the last 12 months HIV infection

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pre-Transplant Group<br>VZV Subunit vaccine will be administered | Biological: VZV subunit vaccine<br>* VZV subunit vaccine<br>|
| Experimental: Post-Transplant Group<br>VZV Subunit vaccine will be administered | Biological: VZV subunit vaccine<br>* VZV subunit vaccine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |