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

Deepali Kumar

Status and phase

Unknown

Phase 4

Conditions

Varicella Zoster Vaccine

Treatments

Biological: VZV subunit vaccine

Study type

Interventional

Funder types

Other

Identifiers

NCT03493776

UHN-Shingrix-001

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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