A Clinical Trial of PepCan to Two Therapy Arms for Treating Cervical High-Grade Squamous Intraepithelial Lesions

NCT02481414 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 202790
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief 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

Cervical Intraepithelial Neoplasia

Keywords

HSIL, CIN II/III

Outcome Measures

Primary Outcomes (4)

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

  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

  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

  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

  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 Outcomes (1)

• Safety Assessed by Injection-related Adverse Events (AEs)

  15 months from time of last vaccination

Study Arms (2)

PepCan

EXPERIMENTAL

Four injections (one every 3 weeks) of PepCan

Biological: PepCan

Candin

ACTIVE COMPARATOR

Four injections (one every 3 weeks) of Candin

Biological: Candin®

Interventions

PepCan BIOLOGICAL

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

Also known as: HPV 16 E6 peptides combined with Candin®

PepCan

Candin® BIOLOGICAL

0.3 mL Candin® per dose administered intradermally in the extremities

Also known as: Candida skin testing reagent

Candin

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

MeSH Terms

Conditions

Uterine Cervical Dysplasia; Squamous Intraepithelial Lesions

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Morphological and Microscopic Findings; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Matthew Kovak, Director of Clinical Trials
• Organization: University of Arkansas for Medical Sciences

MRKovak@uams.edu

501-686-8274

Study Officials

• Mayumi N Nakagawa, MD, PhD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: PepCan or Candin randomized at a 1:1 ratio in a double-blinded design.

Study Record Dates

• First Submitted: June 16, 2015
• First Posted: June 25, 2015
• Study Start: November 30, 2015
• Primary Completion: September 14, 2022
• Study Completion: September 14, 2022
• Last Updated: December 18, 2023
• Results First Posted: December 18, 2023

Record last verified: 2023-11

Locations

US (1)