Clinical trial NCT03685682: Recombinant Subunit Herpes Zoster Vaccine in VZV-Seronegative Organ Transplant Recipients
Official title: Safety and Immunogenicity of Non-live, Recombinant Subunit Herpes Zoster Vaccine in VZV-seronegative Solid Organ Transplant Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Varicella Zoster Vaccine
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2018-09-26
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Humoral immunity to varicella zoster induced by the recombinant subunit Herpes zoster vaccine.
timeFrame: 4 weeks after second dose of vaccine
Secondary outcomes:
measure: Rate of Vaccine-related Adverse Events
timeFrame: Up to 4 weeks after second dose of vaccine
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network, Toronto General Hospital, Multi-Organ Transplant
state: Ontario
Study officials:
affiliation: Multi organ transplant program, University Health Network, Toronto
name: Deepali Kumar, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.