A Clinical Trial of PepCan to Two Therapy Arms for Treating Cervical High-Grade Squamous Intraepithelial Lesions
Condition: Cervical Intraepithelial Neoplasia
MeSH terms: Uterine Cervical Dysplasia
Study type: Interventional
Phase: Phase 2

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).
    

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
    

Intervention name(s): PepCan; Candin®
Intervention type(s): Biological; Biological
Intervention description(s): 50 μg peptide + 0.3 mL Candin® per dose administered intradermally in the extremities; 0.3 mL Candin® per dose administered intradermally in the extremities
Other intervention name(s): HPV 16 E6 peptides combined with Candin®; Candida skin testing reagent
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: PepCan or Candin randomized at a 1:1 ratio in a double-blinded design.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: HSIL, CIN II/III