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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
80
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
Ann & Robert H. Lurie Children's Hospital
Chicago, Illinois, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
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 1. Adverse Events of Special Interests (AESI) including local reactions, clinically diagnosed rejection, or varicella disease through the end of the study period (one year post dose 2) 2. Serious Adverse Events (SAEs) through the end of the study period (one year post dose 2) 3. Potential Immune Mediated Diseases (pIMDs) through the end of the study period (one year post dose 2) 4. Any AE present within 30 days of vaccine administration (dose 1 or dose 2) or pregnancy at any point during the study
Time frame: 30 days-1 year
Anti-glycoprotein E antibody Concentration
Percentage of vaccinees with 4-fold rise in anti-glycoprotein E antibody concentration
Time frame: 30-60 days
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
Time frame: 30-60 days
Acute Rejection Reporting
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
Time frame: 2 months
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