Recombinant Zoster Vaccine in Young Adult Solid Organ Transplant Recipients
Part of paid clinical trials in Chicago, Illinois.
- Sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
- Study ID
- NCT06162494
- Phase
- PHASE4
- Status
- Enrolling By Invitation
Conditions
- Varicella Zoster
Eligibility Criteria
- Sex
- ALL
- Age
- 19 Years - 40 Years
- Healthy Volunteers
- Not accepted
Interventions
- Recombinant Zoster Vaccine — BIOLOGICALAfter 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
Study Details
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.
Key Dates
- Start date
- Mar 18, 2024
- Status verified
- Mar 2026
- Primary completion
- Mar 31, 2027
- Completion
- Sep 30, 2028
Study Design
- Enrollment
- 80 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- PREVENTION
Arms
- Experimental: Recombinant Zoster Vaccine Administration and Testingall participants will receive 2 doses of recombinant zoster vaccine (Shingrix)
Primary Outcome Measure
Adverse Event Reporting [ Time Frame: 30 days-1 year ]
Locations (3)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Ann & Robert H. Lurie Children's Hospital | Chicago | Illinois | 60611 | - |
| Northwestern Memorial Hospital | Chicago | Illinois | 60611 | - |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | - |