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

NCT03493776 | Unknown Phase 4

• 1 other identifier: UHN-Shingrix-001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Varicella Zoster Vaccine

Outcome Measures

Primary Outcomes (1)

• Cellular immunity to varicella zoster induced by varicella zoster subunit 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).

  4 weeks after second dose of vaccine

Secondary Outcomes (2)

• Humoral immunogenicity to varicella zoster induced by varicella zoster subunit vaccine in lung transplant recipients.

  4 weeks after second dose of vaccine

• 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

Study Arms (2)

Pre-Transplant Group

ACTIVE COMPARATOR

VZV Subunit vaccine will be administered

Biological: VZV subunit vaccine

Post-Transplant Group

EXPERIMENTAL

VZV Subunit vaccine will be administered

Biological: VZV subunit vaccine

Interventions

VZV subunit vaccine BIOLOGICAL

VZV subunit vaccine

Post-Transplant Group; Pre-Transplant Group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Single or double lung transplant recipient.
• Age ≥50 years

You may not qualify if:

• 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)
• On waiting list for lung transplantation
• Age ≥50 years
• Has already received Shingrix or Zostavax (live shingles vaccine) in the past
• Systemic prednisone ≥20 mg per day (or equivalent dose of any corticosteroid)
• Other (than prednisone \< 20mg per day or equivalent dose of any corticosteroid) systemic immunosuppressive therapy such as mycophenolate or tacrolimus
• Shingles within the last 12 months
• HIV infection

Sponsors & Collaborators

• Deepali Kumar: lead

Study Sites (1)

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

Toronto, Ontario, M5G2N2, Canada

Location

Study Officials

• Deepali Kumar, MD

  Multi organ transplant program, University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 29, 2018
• First Posted: April 10, 2018
• Study Start: April 15, 2018
• Primary Completion: September 5, 2019
• Study Completion: April 1, 2021
• Last Updated: October 19, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)