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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03685682
Other study ID # UHNTID007
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date May 25, 2018
Est. completion date September 5, 2019

Study information

Verified date August 2020
Source University Health Network, Toronto
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 23
Est. completion date September 5, 2019
Est. primary completion date September 5, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
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

Locations

Country Name City State
Canada University Health Network, Toronto General Hospital, Multi-Organ Transplant Toronto Ontario

Sponsors (1)

Lead Sponsor Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Rate of Vaccine-related Adverse Events Adverse events will be graded as mild, moderate, severe Up to 4 weeks after second dose of vaccine
See also
  Status Clinical Trial Phase
Completed NCT05924685 - PREPARE-iVAC Trial Phase 4
Active, not recruiting NCT03493776 - Safety and Immunogenicity of Non-live, Recombinant Subunit Herpes Zoster Vaccine Before and After Lung Transplantation Phase 4