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

NCT ID: NCT03493776

Last Updated: 2020-10-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-15
• Study Completion Date: 2021-04-30

Brief Summary

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

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.

Conditions

Varicella Zoster Vaccine

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Pre-Transplant Group

VZV Subunit vaccine will be administered

Group Type: ACTIVE_COMPARATOR

VZV subunit vaccine

Intervention Type: BIOLOGICAL

VZV subunit vaccine

Post-Transplant Group

VZV Subunit vaccine will be administered

Group Type: EXPERIMENTAL

VZV subunit vaccine

Intervention Type: BIOLOGICAL

VZV subunit vaccine

Interventions

VZV subunit vaccine

VZV subunit vaccine

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Single or double lung transplant recipient.
• Age ≥50 years

• On waiting list for lung transplantation
• Age ≥50 years

Exclusion Criteria

• 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)

• 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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Deepali Kumar

OTHER

Sponsor Role: lead

Responsible Party

Deepali Kumar

MD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Deepali Kumar, MD

Role: PRINCIPAL_INVESTIGATOR

Multi organ transplant program, University Health Network, Toronto

Locations

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

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

UHN-Shingrix-001

Identifier Type: -

Identifier Source: org_study_id