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NCT02481414 · ClinicalTrials.gov registry record · Phase 2
A Clinical Trial of PepCan to Two Therapy Arms for Treating Cervical High-Grade Squamous Intraepithelial Lesions
A Phase 2 study of Cervical Intraepithelial Neoplasia, sponsored by University of Arkansas.
- Completed
- Registry status
- Phase 2
- Development phase
- 81
- Enrollment target
- 1
- Study location
NCT02481414 is a Phase 2 study of Cervical Intraepithelial Neoplasia that has completed, run by University of Arkansas. The registered enrollment target is 81 participants, below the 257-participant average among 6 other Cervical Intraepithelial Neoplasia trials with a reported enrollment target (68% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02481414, a Phase 2 study of Cervical Intraepithelial Neoplasia, has completed, sponsored by University of Arkansas.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 81 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a Phase II study to evaluate the efficacy and safety of a human papilloma virus (HPV) therapeutic vaccine called PepCan (HPV 16 E6 peptides combined with Candida skin testing reagent called Candin®) in adult females over a 12 month time period. As the results from the Phase I trial demonstrated some efficacy against non-16 HPV types, Candin alone will also be tested. Therefore, there will be two treatment arms: (1) PepCan and (2) Candin. Subjects found to be eligible for vaccination will be randomized in a double-blinded fashion at a 1:1 ratio. Each participant will be receiving injections four times with three weeks between injections. Clinical and virological responses will be assessed at 6 and 12 months. Safety will be assessed from the time of enrollment to 12 Month Visit. Immunological assessments will be made at 4 time points (prevaccination, after 2 injections, 6 month after 4 injections and 12 months after 4 vaccinations).
Conditions Studied
Interventions
- BIOLOGICAL PepCan
- BIOLOGICAL Candin®
Study Locations (1)
Arkansas
- University of Arkansas for Medical Sciences - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 81 participants |
| Start Date | 2015-11-30 |
| Est. Completion | 2022-09-14 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02481414
The ClinicalTrials.gov registry entry for NCT02481414 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 81 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 257-participant average among 6 other Cervical Intraepithelial Neoplasia trials with a reported enrollment target (68% lower). The listed sponsor is University of Arkansas, which has 318 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Cervical Intraepithelial Neoplasia appearing as the primary indexed condition, and to 2 interventions - of which PepCan is the first listed.
NCT02481414 reports 1 study location spanning 1 distinct geographic area - top geographies include Arkansas.
Frequently Asked Questions
What is clinical trial NCT02481414 about?
NCT02481414 is a clinical study titled "A Clinical Trial of PepCan to Two Therapy Arms for Treating Cervical High-Grade Squamous Intraepithelial Lesions". This is a Phase II study to evaluate the efficacy and safety of a human papilloma virus (HPV) therapeutic vaccine called PepCan (HPV 16 E6 peptides combined with Candida skin testing reagent called Candin®) in adult females over a 12 month time period. As the results from the Phase I trial demonstra...
What is the current status of trial NCT02481414?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 81 participants. The study started on 2015-11-30. Estimated completion is 2022-09-14.
What conditions does trial NCT02481414 study?
This clinical trial studies the following conditions: Cervical Intraepithelial Neoplasia.
What interventions are being tested in trial NCT02481414?
The interventions under investigation include: PepCan (BIOLOGICAL), Candin® (BIOLOGICAL).
Who is sponsoring clinical trial NCT02481414?
This trial is sponsored by University of Arkansas, which has 318 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02481414 being conducted?
This trial has 1 study location across Arkansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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