Safety and Immunogenicity of Shingrix in Renal Transplant Recipients

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

This study evaluates the safety and immune response of the Shingrix vaccine in kidney transplant recipients. Participants on the waiting list for kidney transplant will be given the standard 2 doses of Shingrix. Those participants who have been transplanted by 16 months, may be given a 3rd dose of Shingrix.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• On the waiting list at the participating institutions for renal transplantation with anticipated transplantation to occur at \> 3 months to 16 months after listing.

• Female subjects of non-childbearing potential (tubal ligation, hysterectomy,ovariectomy or post-menopausal

• Female subjects of childbearing potential who have practiced adequate contraception for 30 days prior to vaccination, have a negative pregnancy test on day of vaccination, and have agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccine series

Locations
United States
Colorado
University of Colorado Anschutz
RECRUITING
Aurora
Contact Information
Primary
Tori Rutherford, RN BSN
tori.rutherford@childrenscolorado.org
303-724-2454
Time Frame
Start Date: 2023-03-02
Estimated Completion Date: 2026-09
Participants
Target number of participants: 132
Treatments
Active_comparator: Transplanted subject
In addition to receiving standard dose (2) of Shingrix prior to transplantation, participant may receive a 3rd dose several months after transplantation if they meet criteria related to no rejection.
Sham_comparator: Non-Transplanted subject
Receives standard Shingrix dose (2), but not transplanted within 16 month time frame post-dose, so does not receive additional Shingrix dose.
Related Therapeutic Areas
Sponsors
Leads: University of Colorado, Denver

This content was sourced from clinicaltrials.gov