A Clinical Trial of PepCan to Two Therapy Arms for Treating Cervical High-Grade Squamous Intraepi… (NCT02481414) | Clinical Trial Compass
CompletedPhase 2
A Clinical Trial of PepCan to Two Therapy Arms for Treating Cervical High-Grade Squamous Intraepithelial Lesions
United States81 participantsStarted 2015-11-30
Plain-language 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).
Who can participate
Age range
18 Years – 50 Years
Sex
FEMALE
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:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Subjects With Complete Response With the Intention-to-treat (ITT) Analysis
Timeframe: 15 months from time of last vaccination
2
Number of Subjects With Complete Response With the Per-protocol Analysis
Timeframe: 15 months from time of last vaccination
3
Number of Subjects With Complete and Partial Responses With the ITT Analysis
Timeframe: 15 months from time of last vaccination
4
Number of Subjects With Complete and Partial Responses With the Per-protocol Analysis
Timeframe: 15 months from time of last vaccination