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NCT03036930 · ClinicalTrials.gov registry record · Phase 2
Preventive Human Papillomavirus (HPV) Vaccine Trial in Kidney Transplant Recipients
A Phase 2 study of Human Papillomavirus Infection and Human Papillomavirus-Related Carcinoma, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 2
- Development phase
- 51
- Enrollment target
- 6
- Study locations
NCT03036930: Active Phase 2 study of Human Papillomavirus Infection and Human Papillomavirus-Related Carcinoma, sponsored by National Cancer Institute (NCI).
NCT03036930 is a Phase 2 study of Human Papillomavirus Infection and Human Papillomavirus-Related Carcinoma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 51 participants, below the 1,276-participant average among 22 other Human Papillomavirus Infection trials with a reported enrollment target (96% lower). The trial reports 6 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03036930, a Phase 2 study of Human Papillomavirus Infection and Human Papillomavirus-Related Carcinoma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 51 participants
- Enrollment target
- 6
- Study locations
Study 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.
Primary Outcome
An estimate of the Human papillomavirus (HPV) vaccine-type-specific seroconversion rate provided along with exact Clopper-Pearson 95% confidence intervals (CIs). All participants who received a kidney transplant were included in the primary endpoint analysis, regardless of whether the last vaccine dose was administered ≥ 30 days prior to transplantation.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- OTHER Questionnaire Administration
- BIOLOGICAL Recombinant Human Papillomavirus Nonavalent Vaccine
- PROCEDURE HPV Self-Collection
Study Locations (6)
California
- Cedars Sinai Medical Center - Los Angeles
- UCSF Medical Center-Mount Zion - San Francisco
Alabama
- University of Alabama at Birmingham Cancer Center - Birmingham
Illinois
- Northwestern University - Chicago
Minnesota
- Mayo Clinic in Rochester - Rochester
North Carolina
- UNC Lineberger Comprehensive Cancer Center - Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2017-06-23 |
| Est. Completion | 2026-03-06 |
| Phase | Phase 2 |
What the registry record for NCT03036930 still lists
NCT03036930 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 1,276-participant average among 22 other Human Papillomavirus Infection trials with a reported enrollment target (96% lower).
The record links to 2 conditions, with Human Papillomavirus Infection appearing as the primary indexed condition, and to 4 interventions - of which Biospecimen Collection is the first listed.
NCT03036930 lists 6 locations in 5 states (California, Alabama, Illinois).
Frequently Asked Questions
What is clinical trial NCT03036930 about?
NCT03036930 is a clinical study titled "Preventive Human Papillomavirus (HPV) Vaccine Trial in Kidney Transplant Recipients". 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 rejectio...
What is the current status of trial NCT03036930?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 51 participants. The study started on 2017-06-23. Estimated completion is 2026-03-06.
What conditions does trial NCT03036930 study?
This clinical trial studies the following conditions: Human Papillomavirus Infection, Human Papillomavirus-Related Carcinoma.
What interventions are being tested in trial NCT03036930?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Questionnaire Administration (OTHER), Recombinant Human Papillomavirus Nonavalent Vaccine (BIOLOGICAL), HPV Self-Collection (PROCEDURE).
Who is sponsoring clinical trial NCT03036930?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03036930 being conducted?
This trial has 6 study locations across Alabama, California, Illinois, Minnesota, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT03036930's enrollment target sits among peer trials
51 21st of 22 higher than 2 of 22 other Human Papillomavirus Infection trials
participants (enrollment target), bucketed by value
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