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

University Health Network, Toronto

Status and phase

Completed

Phase 3

Conditions

Varicella Zoster Vaccine

Treatments

Biological: recombinant subunit Herpes zoster vaccine

Study type

Interventional

Funder types

Other

Identifiers

NCT03685682

UHNTID007

Details and patient eligibility

About

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.

Full 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.

Enrollment

23 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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