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Safety and Immunogenicity of Shingrix in Renal Transplant Recipients
NCT04128189Phase 3
Key facts
- Status
- Recruiting
- Start
- Mar 2023
- Primary completion
- Jun 2029
- Countries
- 1
- Sponsor
- University of Colorado Denver
- Modality
- Vaccines & Immunotherapeutics
- Conditions
- herpes zoster (HZ)
01
Overview
Phase 3, randomised, open-label trial of Zoster vaccine recombinant in herpes zoster (HZ) (2 arms), sponsored by University of Colorado Denver. Primary endpoint: gE-Specific IL-2 T Cell Response at 12 Months After Randomization. Started Mar 2023; status: recruiting.
02
Design
2 arms- Study design
- RandomizedOpen-label
Transplanted subject
Experimental Arm: Third Dose of Shingrix (Post-Transplant)
No Intervention Comparator Arm: No Third Dose (Post-Transplant)
No Intervention Comparator Arm: No Third Dose (Post-Transplant)
03
Who it enrols
Adults aged 18-70 with chronic kidney failure on the waiting list for a kidney transplant, excluding those with active immunosuppressive conditions, recent history of herpes zoster, or recent receipt of certain vaccines or investigational drugs.
04
Endpoints
Primary
gE-Specific IL-2 T Cell Response at 12 Months After Randomization
Secondary
Vaccine Response (VR) at 30 Days After Second Dose
Geometric Mean Fold Rise (GMFR) in gE-Specific IL-2 Responses at 30 Days After Second Dose
Geometric Mean Fold Rise (GMFR) in Previously Vaccinated Participants
Immunogenicity at >=2 Months Post-Transplant
Immune Response 30 Days After Third Dose (Post-Transplant)
Geometric Mean Fold Rise (GMFR) at 1 Year Post-Randomization
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