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

Deepali Kumar50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Varicella Zoster Vaccine

Interventions

VZV subunit vaccineBIOLOGICAL

VZV subunit vaccine

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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

Locations (1)

University Health Network, Toronto General Hospital, Multi-Organ Transplant

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

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).

Time frame: 4 weeks after second dose of vaccine

Secondary Outcomes

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

Time frame: 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.

Time frame: 4 weeks after second dose of vaccine

Data from ClinicalTrials.gov

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