Preventive Human Papillomavirus (HPV) Vaccine Trial in Kidney Transplant Recipients (NCT03036930) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Preventive Human Papillomavirus (HPV) Vaccine Trial in Kidney Transplant Recipients
United States51 participantsStarted 2017-06-23
Plain-language summary
This phase II trial studies whether the nonavalent human papillomavirus vaccine given to adults prior to kidney transplantation can help the body build and maintain an effective immune response during the post-transplant period when they receive immunosuppressive drugs to prevent transplant rejection. This study will help inform our scientific understanding about vaccine-induced immune responses among immunosuppressed individuals.
Who can participate
Age range18 Years – 49 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Candidate for renal transplant, expected to undergo transplant surgery \>= 30 days and =\< 12 months after enrollment
* For potential participants on the institutional waiting list for deceased donor transplant, a study clinician confirms the candidate is likely to receive a transplant within the next 12 months, taking into account the candidate's priority on the waiting list, age, medical status, institutional policies, and scores like the Estimated Post-Transplant Survival (EPTS) Score and Calculated Panel Reactive Antibody (CPRA) percentage, etc
* For potential participants expected to undergo a living donor transplant, one or more donor(s) have been identified and is/are in work-up (even though all work-up status may or may not be complete); a study clinician confirms the living donor transplant is likely to be scheduled within the next twelve months after taking into account donor work-up progress, age and medical status, and institutional policies
* Notes:
* Living and deceased donor transplant recipients: The study was originally restricted to participants who were expecting to receive only living donor renal transplants; however, less than a third of kidney transplants in the United States occur with kidneys from living donors; a majority of transplants are in the setting of donation of kidneys from deceased donors; to permit efficiencies in accrual, the study is amended (from version 3.5) to also open enrollment to recipients of dec…
What they're measuring
1
HPV Vaccine-type-specific Seroconversion Rates Among Kidney Transplant Recipients Who Received ≥ 1 Doses of the Vaccine.