Safety and Immunogenicity of Non-live, Recombinant Subunit Herpes Zoster Vaccine Before and After Lung Transplantation

Phase 4

• Conditions: Varicella Zoster Vaccine
• Interventions: Biological: VZV subunit vaccine

• Registration Number: NCT03493776
• Lead Sponsor: Deepali Kumar

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.

Study Timeline

• Study First Submitted: 2018-03-29
• Study First Submitted QC: 2018-04-09
• Study First Posted: 2018-04-10
• Study Start: 2018-04-15
• Primary Completion: 2019-09-05
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-16
• Last Update Posted: 2020-10-19
• Study Completion: 2021-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Post-Transplant Group	VZV subunit vaccine	VZV Subunit vaccine will be administered
Pre-Transplant Group	VZV subunit vaccine	VZV Subunit vaccine will be administered

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

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