A Clinical Trial of PepCan to Two Therapy Arms for Treating Cervical High-Grade Squamous Intraepithelial Lesions
Purpose
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).
Condition
- Cervical Intraepithelial Neoplasia
Eligibility
- Eligible Ages
- Between 18 Years and 50 Years
- Eligible Genders
- Female
- Accepts Healthy Volunteers
- No
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 with a good command of the English language
Exclusion Criteria
- History of disease or treatment causing immunosuppression (e.g., cancer, human immunodeficiency virus, 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
- Current use of beta-blocker medication (may not respond to epinephrine in case of anaphylaxis)
- 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
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental PepCan |
PepCan 50 mcg per peptide/injection plus 0.3 mL Candin |
|
|
Active Comparator Candin |
0.3 mL Candin plus sterile saline |
|
Recruiting Locations
Little Rock, Arkansas 72205
More Details
- NCT ID
- NCT02481414
- Status
- Recruiting
- Sponsor
- University of Arkansas
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 [14]. Study subjects will be patients attending the 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 LEEP visits. HPV-DNA testing will be performed at Screening and 6- and 12-Month Visits (Fig. 6). 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