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

NCT03685682 | Completed Phase 3

• 1 other identifier: UHNTID007
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Varicella Zoster Vaccine

Outcome Measures

Primary Outcomes (1)

• 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

  4 weeks after second dose of vaccine

Secondary Outcomes (1)

• Rate of Vaccine-related Adverse Events

  Up to 4 weeks after second dose of vaccine

Study Arms (1)

VZV seronegative Transplant Patients

EXPERIMENTAL

recombinant subunit Herpes zoster vaccine

Biological: recombinant subunit Herpes zoster vaccine

Interventions

recombinant subunit Herpes zoster vaccine BIOLOGICAL

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

VZV seronegative Transplant Patients

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

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

Toronto, Ontario, M5G2N2, Canada

Location

Related Publications (1)

• L'Huillier AG, Hirzel C, Ferreira VH, Ierullo M, Ku T, Selzner N, Schiff J, Juvet S, Miao C, Schmid DS, Humar A, Kumar D. Evaluation of Recombinant Herpes Zoster Vaccine for Primary Immunization of Varicella-seronegative Transplant Recipients. Transplantation. 2021 Oct 1;105(10):2316-2323. doi: 10.1097/TP.0000000000003621.

  PMID: 33528118 DERIVED

Study Officials

• Deepali Kumar, MD

  Multi organ transplant program, University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 23, 2018
• First Posted: September 26, 2018
• Study Start: May 25, 2018
• Primary Completion: September 5, 2019
• Study Completion: September 5, 2019
• Last Updated: August 5, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)