A Clinical Trial of PepCan to Two Therapy Arms for Treating Cervical High-Grade Squamous Intraepithelial Lesions
| Status: | Recruiting |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 3/15/2019 |
| Start Date: | October 2015 |
| End Date: | August 2020 |
| Contact: | James Ike Allred, BA |
| Email: | jiallred@uams.edu |
| Phone: | 501-686-8274 |
A Phase II Clinical Trial of PepCan Randomized and Double-Blinded to Two Therapy Arms for Treating Cervical High-Grade Squamous Intraepithelial Lesions
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).
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).
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
We found this trial at
1
site
529 West Markham Street
Little Rock, Arkansas 72205
Little Rock, Arkansas 72205
(501) 686-7000
Principal Investigator: Mayumi Nakagawa, MD, PhD
Phone: 501-686-8274
University of Arkansas for Medical Sciences The University of Arkansas for Medical Sciences (UAMS) in...
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