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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

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

ArmDescriptionAssigned Intervention
Experimental
PepCan 		PepCan 50 mcg per peptide/injection plus 0.3 mL Candin
  • Biological: Pepcan+Candin
Active Comparator
Candin 		0.3 mL Candin plus sterile saline
  • Biological: Candin

Recruiting Locations

University of Arkansas for Medical Sciences
Little Rock, Arkansas 72205
Contact:
James Ike Allred, BA, CCRP
501-686-8274
jiallred@uams.edu

More Details

NCT ID
NCT02481414
Status
Recruiting
Sponsor
University of Arkansas

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.