Clinical trial NCT03493776: Safety and Immunogenicity of Non-live, Recombinant Subunit Herpes Zoster Vaccine Before and After Lung Transplantation
Official title: Safety and Immunogenicity of Non-live, Recombinant Subunit Herpes Zoster Vaccine Before and After Lung Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Varicella Zoster Vaccine
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2018-04-10
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Cellular immunity to varicella zoster induced by varicella zoster subunit vaccine.
timeFrame: 4 weeks after second dose of vaccine
Secondary outcomes:
measure: Humoral immunogenicity to varicella zoster induced by varicella zoster subunit vaccine in lung transplant recipients.
timeFrame: 4 weeks after second dose of vaccine
measure: Humoral immunogenicity to varicella zoster induced by varicella zoster subunit vaccine in post-transplant group vs. pre-transplant group
timeFrame: 4 weeks after second dose of vaccine
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network, Toronto General Hospital, Multi-Organ Transplant
state: Ontario
Study officials:
affiliation: Multi organ transplant program, University Health Network, Toronto
name: Deepali Kumar, MD
role: PRINCIPAL_INVESTIGATOR
References: