Varicella Zoster Vaccine
Conditions
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.
Interventions
BIOLOGICALVZV subunit vaccine
VZV subunit vaccine
Sponsors
Deepali Kumar
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cellular immunity to varicella zoster induced by varicella zoster subunit vaccine. | 4 weeks after second dose of 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Humoral immunogenicity to varicella zoster induced by varicella zoster subunit vaccine in lung transplant recipients. | 4 weeks after second dose of vaccine | Humoral immunogenicity (increase of GMTs of anti-VZV antibodies) in lung transplant |
| Humoral immunogenicity to varicella zoster induced by varicella zoster subunit vaccine in post-transplant group vs. pre-transplant group | 4 weeks after second dose of vaccine | 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. |
Countries
Canada
Outcome results
None listed