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

Phase 3

Completed

• Conditions: Varicella Zoster Vaccine
• Interventions: Biological: recombinant subunit Herpes zoster vaccine

• Registration Number: NCT03685682
• Lead Sponsor: University Health Network, Toronto

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.

Study Timeline

• Study Start: 2018-05-25
• Study First Submitted: 2018-09-23
• Study First Submitted QC: 2018-09-24
• Study First Posted: 2018-09-26
• Primary Completion: 2019-09-05
• Study Completion: 2019-09-05
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-04
• Last Update Posted: 2020-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

• Solid organ transplant recipient.
• Age ≥18 years
• VZV-seronegative at time of transplant
• ≥90 days post-transplant
• Able to provide informed consent

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
VZV seronegative Transplant Patients	recombinant subunit Herpes zoster vaccine	recombinant subunit Herpes zoster vaccine

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Rate of Vaccine-related Adverse Events	Up to 4 weeks after second dose of vaccine	Adverse events will be graded as mild, moderate, severe

Trial Locations

Locations (1)

University Health Network, Toronto General Hospital, Multi-Organ Transplant; 🇨🇦 Toronto, Ontario, Canada