Varicella Zoster Vaccine
Conditions
Brief summary
The investigators plan to study the immunogenicity of the vaccine in VZV-seronegative solid organ transplant recipients. VZV-seronegative patients will be enrolled after organ transplantation. The investigators hypothesize that the recombinant subunit Herpes zoster vaccine is able to induce cellular immunogenicity after transplantation in VZV-seronegative patients.
Detailed description
Solid organ transplant recipients receive lifelong immunosuppression and are at increased risk for severe primary VZV infection (chickenpox) and VZV reactivation (shingles). A non-live, recombinant subunit Herpes zoster vaccine (Shingrix; GSK vaccines) was recently licensed for the prevention of shingles in people aged 50 years or older and was shown to induce both cellular and humoral immunity. As both components of the immune system are important for protection against VZV, the investigators plan to study the humoral and cellular immunogenicity of the vaccine after organ transplantation in VZV-seronegative patients. Indeed, the current live VZV vaccine is contraindicated after transplantation; therefore, the non-live recombinant varicella-zoster subunit vaccine, if shown to induce cellular and humoral immunity, could potentially be offered to VZV-seronegative transplant patients.
Interventions
Seronegative Solid Organ Transplant patients will receive two doses of the subunit Herpes zoster vaccine at 0 and 2-6 months
Sponsors
University Health Network, Toronto
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Solid organ transplant recipient. * Age ≥18 years * VZV-seronegative at time of transplant * ≥90 days post-transplant * Able to provide informed consent
Exclusion criteria
* Has already received the recombinant subunit Herpes zoster vaccine in the past * Ongoing CMV viremia \> 200 IU/mL * HIV infection * Diagnosis of malignancy (e.g. PTLD) * History of a severe allergic reaction (anaphylactic reaction) after any vaccine * Documented Chickenpox or Shingles after transplantation * Congenital immunodeficiency (e.g., CVID) * Treatment for rejection in the past 30 days * Immunoglobulin in the past 30 days or anticipated to receive immunoglobulin * Anti-CD20 monoclonal antibody in the past 6 months or anticipated to receive Anti-CD20 monoclonal antibody * Plasmapheresis in the past 30 days or anticipated to receive plasmapheresis * Febrile illness in the past one week * Unable to comply with the study protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Humoral immunity to varicella zoster induced by the recombinant subunit Herpes zoster vaccine. | 4 weeks after second dose of vaccine | Fold increase in concentration of anti-gE antibody titer from pre- to post-vaccination |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Vaccine-related Adverse Events | Up to 4 weeks after second dose of vaccine | Adverse events will be graded as mild, moderate, severe |
Countries
Canada
Outcome results
None listed