Human papillomavirus (HPV) is known to cause cervical, vaginal, oral, penile and anal cancers. Cervical cancer is still one of the most common cancers among women in the developing regions of the world. This Phase II clinical trial will look at the effectiveness and safety of a new therapeutic HPV vaccine designed to work against a precancerous condition called high-grade squamous epithelial lesion (HSIL). The current standard treatment for HSIL is loop electrical excision procedure (LEEP). This treatment is effective, but is also known to result in doubling of premature births in following pregnancies.
With further testing, we hope this novel vaccine, called PepCan, may eventually become a non-surgical alternative for treating HSIL avoiding such premature births, as it keeps the cervix physically intact. The vaccine consists of synthetically made fragments of HPV protein called E6 and yeast extract called Candin® as a novel vaccine adjuvant. Our previous studies have revealed that injecting Candin has an anti-HPV effect since it has been used to treat common warts which are caused by different types of HPV.
The immune system is the part of the body that fights infection and cancer. Therefore, this study will test both PepCan and Candin as possible treatment to regress HSILs. You would be eligible to enroll in the study if you have had a recent Papanicolaou (Pap) smear results indicating that you have HSIL or “cannot rule out HSIL”, and if you meet all of the inclusion/exclusion criteria. The presence of HSIL will be confirmed by performing a biopsy, and you’ll be eligible to receive vaccination if the diagnosis of HSIL is confirmed. You’ll also be eligible to enroll if you already had a biopsy confirming HSIL but are still untreated.