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
Intervention: PepCan; Candin®
Intervention description: 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
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
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)
Enrollment: 81.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: HSIL, CIN II/III

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).
    

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