Varicella Zoster Vaccine Clinical Trial
Official title:
Safety and Immunogenicity of Non-live, Recombinant Subunit Herpes Zoster Vaccine in VZV-seronegative Solid Organ Transplant Recipients
Verified date | August 2020 |
Source | University Health Network, Toronto |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Canada | University Health Network, Toronto General Hospital, Multi-Organ Transplant | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
University Health Network, Toronto |
Canada,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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Phase 4 | |
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Safety and Immunogenicity of Non-live, Recombinant Subunit Herpes Zoster Vaccine Before and After Lung Transplantation
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