Clinical trial · Interventional
A Clinical Trial of PepCan to Two Therapy Arms for Treating Cervical High-Grade Squamous Intraepithelial Lesions
A Phase II Clinical Trial of PepCan Randomized and Double-Blinded to Two Therapy Arms for Treating Cervical High-Grade Squamous Intraepithelial Lesions
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Intraepithelial Neoplasia | Cervical Intraepithelial Neoplasia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Candin® | Biological | — | UNRESOLVED |
| PepCan | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- PepCan
- description
- Four injections (one every 3 weeks) of PepCan
- interventionNames
- Biological: PepCan
- type
- ACTIVE_COMPARATOR
- label
- Candin
- description
- Four injections (one every 3 weeks) of Candin
- interventionNames
- Biological: Candin®
Primary outcomes (4)
- measure
- Number of Subjects With Complete Response With the Intention-to-treat (ITT) Analysis
- timeFrame
- 15 months from time of last vaccination
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 50 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available