Recombinant Subunit Herpes Zoster Vaccine in VZV-Seronegative Organ Transplant Recipients

University Health Network, Toronto23 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Varicella Zoster Vaccine

Interventions

recombinant subunit Herpes zoster vaccineBIOLOGICAL

Seronegative Solid Organ Transplant patients will receive two doses of the subunit Herpes zoster vaccine at 0 and 2-6 months

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

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

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

Humoral immunity to varicella zoster induced by the recombinant subunit Herpes zoster vaccine.

Fold increase in concentration of anti-gE antibody titer from pre- to post-vaccination

Time frame: 4 weeks after second dose of vaccine

Secondary Outcomes

Rate of Vaccine-related Adverse Events

Adverse events will be graded as mild, moderate, severe

Time frame: Up to 4 weeks after second dose of vaccine

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.