Clinical trial

A Phase II Clinical Trial of PepCan Randomized and Double-Blinded to Two Therapy Arms for Treating Cervical High-Grade Squamous Intraepithelial Lesions

Name

202790

Description

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).

Trial arms

Trial start

2015-11-30

Estimated PCD

2022-09-14

Trial end

2022-09-14

Status

Completed

Phase

Early phase I

Treatment

PepCan

50 μg peptide + 0.3 mL Candin® per dose administered intradermally in the extremities

Arms:

PepCan

Other names:

HPV 16 E6 peptides combined with Candin®

Candin®

0.3 mL Candin® per dose administered intradermally in the extremities

Arms:

Candin

Other names:

Candida skin testing reagent

Size

Primary endpoint

Number of Subjects With Complete Response With the Intention-to-treat (ITT) Analysis

15 months from time of last vaccination

Number of Subjects With Complete Response With the Per-protocol Analysis

15 months from time of last vaccination

Number of Subjects With Complete and Partial Responses With the ITT Analysis

15 months from time of last vaccination

Number of Subjects With Complete and Partial Responses With the Per-protocol Analysis

15 months from time of last vaccination

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'PepCan or Candin randomized at a 1:1 ratio in a double-blinded design.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 81, 'type': 'ACTUAL'}}

Updated at

2023-12-18

1 organization

2 products

2 abstracts

1 indication

Organization

University of Arkansas

Product

PepCan

Indication

Cervical Intraepithelial Neoplasia