Recombinant Subunit Herpes Zoster Vaccine in VZV-Seronegative Organ Transplant Recipients

Study Overview
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Brief Summary
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The investigators plan to study the immunogenicity of the vaccine in VZV-seronegative solid organ transplant recipients. VZV-seronegative patients will be enrolled after organ transplantation. The investigators hypothesize that the recombinant subunit Herpes zoster vaccine is able to induce cellular immunogenicity after transplantation in VZV-seronegative patients.

Detailed Description
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Solid organ transplant recipients receive lifelong immunosuppression and are at increased risk for severe primary VZV infection (chickenpox) and VZV reactivation (shingles). A non-live, recombinant subunit Herpes zoster vaccine (Shingrix; GSK vaccines) was recently licensed for the prevention of shingles in people aged 50 years or older and was shown to induce both cellular and humoral immunity. As both components of the immune system are important for protection against VZV, the investigators plan to study the humoral and cellular immunogenicity of the vaccine after organ transplantation in VZV-seronegative patients. Indeed, the current live VZV vaccine is contraindicated after transplantation; therefore, the non-live recombinant varicella-zoster subunit vaccine, if shown to induce cellular and humoral immunity, could potentially be offered to VZV-seronegative transplant patients.

Official Title
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Safety and Immunogenicity of Non-live, Recombinant Subunit Herpes Zoster Vaccine in VZV-seronegative Solid Organ Transplant Recipients

Conditions
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Varicella Zoster Vaccine

Intervention / Treatment
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* Biological: recombinant subunit Herpes zoster vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Solid organ transplant recipient. Age ≥18 years VZV-seronegative at time of transplant ≥90 days post-transplant Able to provide informed consent Exclusion Criteria: Has already received the recombinant subunit Herpes zoster vaccine in the past Ongoing CMV viremia > 200 IU/mL HIV infection Diagnosis of malignancy (e.g. PTLD) History of a severe allergic reaction (anaphylactic reaction) after any vaccine Documented Chickenpox or Shingles after transplantation Congenital immunodeficiency (e.g., CVID) Treatment for rejection in the past 30 days Immunoglobulin in the past 30 days or anticipated to receive immunoglobulin Anti-CD20 monoclonal antibody in the past 6 months or anticipated to receive Anti-CD20 monoclonal antibody Plasmapheresis in the past 30 days or anticipated to receive plasmapheresis Febrile illness in the past one week Unable to comply with the study protocol

Ages Eligible for Study
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Minimum Age: 18 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VZV seronegative Transplant Patients<br>recombinant subunit Herpes zoster vaccine | Biological: recombinant subunit Herpes zoster vaccine<br>* Seronegative Solid Organ Transplant patients will receive two doses of the subunit Herpes zoster vaccine at 0 and 2-6 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Humoral immunity to varicella zoster induced by the recombinant subunit Herpes zoster vaccine. | Fold increase in concentration of anti-gE antibody titer from pre- to post-vaccination | 4 weeks after second dose of vaccine | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Vaccine-related Adverse Events | Adverse events will be graded as mild, moderate, severe | Up to 4 weeks after second dose of vaccine |