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| Name | Class |
|---|---|
| Children's Hospital Colorado | OTHER |
| Children's Hospital Medical Center, Cincinnati | OTHER |
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This goal of this study is to assess the safety and immunogenicity of recombinant zoster virus in young adult solid organ transplant recipients. In this study, participants will receive the recombinant zoster vaccine. They will be monitored for adverse events and tested for antibody and cellular immunity.
This is an open-label, non-blinded study to assess the safety and immunogenicity of the Recombinant Zoster Vaccine (RZV) in young adult recipients of solid organ transplants (heart, liver, kidney). After obtaining consent, the patient will have pre-vaccine baseline Varicella Zoster Virus (VZV) anti-gE antibody testing performed by the Weinberg lab and then will be given first dose of vaccine. Participants will be brought back 30-60 days post-vaccine for follow up testing and second dose of vaccine. Participants will then be brought in for follow-up testing at 1-2 months, 6 months, and 12-15 months after receiving 2nd dose of vaccine. Testing for both antibody and cellular immunity to VZV will be performed throughout the study. Telephone, electronic and in-person follow up will be conducted to assess for any clinical signs of VZV reactivation, any vaccine-related side effects or any signs of acute rejection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Recombinant Zoster Vaccine Administration and Testing | Experimental | all participants will receive 2 doses of recombinant zoster vaccine (Shingrix) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant Zoster Vaccine | Biological | After giving consent, participants will be given first dose of vaccine. Participants will be brought back 60-90 days post-vaccine for follow up testing and second dose of vaccine |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Event Reporting | Percentage of vaccinees with any adverse event (AE) reported as well as those related to receipt of each dose of a 2-dose series of Recombinant Zoster Vaccine (RZV), to be analyzed within the following categories
| 30 days-1 year |
| Anti-glycoprotein E antibody Concentration | Percentage of vaccinees with 4-fold rise in anti-glycoprotein E antibody concentration | 30-60 days |
| Measure | Description | Time Frame |
|---|---|---|
| Glycoprotein E-Specific Cellular Responses | Percentage of vaccinees with 2-fold rise in glycoprotein E-specific cellular responses as defined by interferon and IL-2 measured by Fluorospot | 30-60 days |
| Acute Rejection Reporting |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory Outcome | Percentage of vaccinees with 4-fold rise in anti-glycoprotein E antibody concentration within groups 1)previous recipients of varicella vaccine during childhood 2)those with natural infection or 3)those with no history of either natural infection/vaccination at Day 30-60 post-dose 2 Comparison of percentage of participants with 2-fold rise in glycoprotein E-specific cellular responses between those with detectable cellular response pre-vaccine vs. those with no detectable response pre-vaccine at Day 30-60 post-dose 2 Percentage of vaccinees with 4-fold rise in anti-glycoprotein E antibody concentration comparing transplant patients with "high" vs. "low" "level of suppression" (defined as # of immunosuppressive agents and/or serum drug level of immunosuppressive agent) at the time of vaccination at Day 30-60 post-dose 2 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ravi Jhaveri, MD | Ann and Robert H Lurie Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ann & Robert H. Lurie Children's Hospital | Chicago | Illinois | 60611 | United States | ||
| Northwestern Memorial Hospital |
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|
Percentage of vaccinees that develop complications of acute rejection within 2 months of receiving each dose of the 2-dose series compared to historical time since transplant-graft- and immunosuppressive regimen-matched unvaccinated controls
| 2 months |
| 30-60 days |
| Chicago |
| Illinois |
| 60611 |
| United States |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |