- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02481414
A Clinical Trial of PepCan to Two Therapy Arms for Treating Cervical High-Grade Squamous Intraepithelial Lesions
November 27, 2023 updated by: University of Arkansas
A Phase II Clinical Trial of PepCan Randomized and Double-Blinded 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 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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is a single site Phase II clinical trial of PepCan for treating women with biopsy-proven HSILs (High Grade Intraepithelial Lesions) randomized and double-blinded to two treatment arms.
Half of the subjects will receive PepCan, and the other half will receive Candin® alone.
The study design closely resembles the latest guidelines for treating young women with HSIL.
Study subjects will be patients attending the University of Arkansas for Medical Sciences (UAMS) Obstetrics and Gynecology Clinics with untreated biopsy-proven HSILs and patients referred from other clinics.
Four injections (one every 3 weeks) of PepCan or Candin® will be intradermally administered in the extremities.
Clinical response will be assessed by comparison of colposcopy-guided biopsy results obtained prior to vaccination and at 12-Month Visit.
Safety will be monitored from the time of enrollment through the 12-Month Visit.
Blood will be drawn for laboratory testing and immunological analyses ("blood test") prior to injection, after the second vaccination, 6 months after the fourth vaccination, and 12 months after the fourth vaccination.
Blood will be drawn to aid T-cell analyses ("blood draw") after the first and third vaccinations, and possibly at the Optional Follow-Up and/or Optional Loop Electrosurgical Excision Procedure (LEEP) visits.
HPV-DNA testing will be performed at Screening and 6- and 12-Month Visits.
If a subject has persistent HSIL at the 12-Month Visit or if a subject is withdrawn due to excessive toxicity, she will be given an option to return for a LEEP visit.
Alternatively, she may choose to exit the study and be followed by a gynecologist for up to 2 years of observation as recommended before surgical treatment
Study Type
Interventional
Enrollment (Actual)
81
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Arkansas
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Little Rock, Arkansas, United States, 72205
- University of Arkansas for Medical Sciences
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Aged 18-50 years
- Had recent (≤ 60 days) Pap smear result consistent with high grade squamous intraepithelial lesion (HSIL) or "cannot rule out HSIL" or HSIL on colposcopy-guided biopsy
- Untreated for HSIL or "Cannot rule out HSIL"
- Able to provide informed consent
- Willingness and able to comply with the requirements of the protocol
Exclusion Criteria:
- History of disease or treatment causing immunosuppression (e.g., cancer, human immunodeficiency virus (HIV), organ transplant, autoimmune disease)
- Being pregnant or attempting to be pregnant within the period of study participation
- Breast feeding or planning to breast feed within the period of study participation
- Allergy to Candida antigen
- History of severe asthma requiring emergency room visit or hospitalization within the past 5 years
- History of invasive squamous cell carcinoma of the cervix
- History of having received PepCan
- If in the opinion of the Principal Investigator or other Investigators, it is not in the best interest of the patient to enter this study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PepCan
Four injections (one every 3 weeks) of PepCan
|
50 μg peptide + 0.3 mL Candin® per dose administered intradermally in the extremities
Other Names:
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Active Comparator: Candin
Four injections (one every 3 weeks) of Candin
|
0.3 mL Candin® per dose administered intradermally in the extremities
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Subjects With Complete Response With the Intention-to-treat (ITT) Analysis
Time Frame: 15 months from time of last vaccination
|
Histological regression of moderate/severe cervical dysplasia to absence of cervical dysplasia assessed using biopsies (stringent)
|
15 months from time of last vaccination
|
Number of Subjects With Complete Response With the Per-protocol Analysis
Time Frame: 15 months from time of last vaccination
|
Histological regression of moderate/severe cervical dysplasia to absence of cervical dysplasia assessed using biopsies (stringent)".
|
15 months from time of last vaccination
|
Number of Subjects With Complete and Partial Responses With the ITT Analysis
Time Frame: 15 months from time of last vaccination
|
Histological regression of moderate/severe cervical dysplasia to mild dysplasia/no dysplasia (lenient) assessed using biopsies, likely avoiding a need for surgery
|
15 months from time of last vaccination
|
Number of Subjects With Complete and Partial Responses With the Per-protocol Analysis
Time Frame: 15 months from time of last vaccination
|
Histological regression of moderate/severe cervical dysplasia to mild dysplasia/no dysplasia (lenient) assessed using biopsies, likely avoiding a need for surgery
|
15 months from time of last vaccination
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety Assessed by Injection-related Adverse Events (AEs)
Time Frame: 15 months from time of last vaccination
|
Injection-related AEs occurring in >5% of injections
|
15 months from time of last vaccination
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mayumi N Nakagawa, MD, PhD, University of Arkansas
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 30, 2015
Primary Completion (Actual)
September 14, 2022
Study Completion (Actual)
September 14, 2022
Study Registration Dates
First Submitted
June 16, 2015
First Submitted That Met QC Criteria
June 24, 2015
First Posted (Estimated)
June 25, 2015
Study Record Updates
Last Update Posted (Estimated)
December 18, 2023
Last Update Submitted That Met QC Criteria
November 27, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202790
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cervical Intraepithelial Neoplasia
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Krankenhaus Barmherzige Schwestern LinzMedical University of ViennaCompletedCervical Intraepithelial Neoplasia Grade 1 | Cervical Intraepithelial Neoplasia Grade 2Austria
-
National Cancer Institute (NCI)TerminatedCervical Cancer | Cervical Intraepithelial Neoplasia Grade 2 | Cervical Intraepithelial Neoplasia Grade 3United States
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Genexine, Inc.CompletedCervical Intraepithelial Neoplasia 3Korea, Republic of
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Nykode Therapeutics ASATheradex; Vaccibody ASCompletedHigh Grade Cervical Intraepithelial NeoplasiaGermany
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University of Alabama at BirminghamNational Cancer Institute (NCI)CompletedHigh-grade Cervical Intraepithelial NeoplasiaUnited States
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National Cancer Institute (NCI)Active, not recruitingCervical Intraepithelial Neoplasia Grade 2/3 | High Grade Cervical Intraepithelial Neoplasia | Cervical Squamous Cell Carcinoma In Situ | Cervical Squamous Intraepithelial Neoplasia 2United States
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Brookdale University Hospital Medical CenterUnknownCarcinoma in Situ of Uterine Cervix | Cervical Intraepithelial Neoplasias | High Grade Cervical Intraepithelial NeoplasiaUnited States
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BioLeaders CorporationUnknownCervical Intraepithelial Neoplasia Grade 2/3Korea, Republic of
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University Medical Centre MariborRecruitingCervical Intraepithelial Neoplasia Grade 2 | DNA MethylationSlovenia
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Onconix, IncUnknownCervical Cancer | Cervical Intraepithelial Neoplasia III | Cervical Intraepithelial Neoplasia IIUnited States
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