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

NCT ID: NCT03685682

Last Updated: 2020-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-25
• Study Completion Date: 2019-09-05

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.

Conditions

Varicella Zoster Vaccine

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

VZV seronegative Transplant Patients

recombinant subunit Herpes zoster vaccine

Group Type: EXPERIMENTAL

recombinant subunit Herpes zoster vaccine

Intervention Type: BIOLOGICAL

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

Interventions

recombinant subunit Herpes zoster vaccine

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Deepali Kumar

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Deepali Kumar, MD

Role: PRINCIPAL_INVESTIGATOR

Multi organ transplant program, University Health Network, Toronto

Locations

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

Toronto, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 33528118 (View on PubMed)

Other Identifiers

UHNTID007

Identifier Type: -

Identifier Source: org_study_id