Little Rock, Arkansas 72205


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).


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 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


NCT ID:

NCT02481414


Primary Contact:

Principal Investigator
Mayumi N Nakagawa, MD, PhD
University of Arkansas

James Ike Allred, BA
Phone: 501-686-8274
Email: jiallred@uams.edu


Backup Contact:

Email: klsimpson@uams.edu
Kacie Simpson, BS
Phone: 501-686-8274


Location Contact:

Little Rock, Arkansas 72205
United States

Ike Allred, BA, CCRP
Phone: 501-686-8274
Email: jiallred@uams.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 23, 2017

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