A Phase 1 interventional study of Vaccine consisting of four HPV-16 E6 peptides in combination with Candin® in Human Papillomavirus, sponsored by University of Arkansas. Completed at 1 site in United States. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2016-10-12.
Sponsored by University of Arkansas · Phase 1 and Interventional
This study will consist of 300 women aged 18-50 years. The study will show that a new therapeutic human papillomavirus (HPV) vaccine designed to regress a precancerous condition called high-grade squamous intraepithelial neoplasia (HSIL)is safe. HPV is known to cause cervical, vaginal, oral, and anal cancers. This novel vaccine will consist of a synthetically made fragment of HPV protein called E6 and yeast extract called Candin®. Previous studies have revealed that immune response to E6 is important in fighting HPV. We also know that injecting Candin has anti-HPV effect since it has been used to treat common warts which are caused by different types of HPV. The current standard treatment for HSIL is loop electrical excision procedure (LEEP). The immune system is the part of the body that fights infection and cancer. This research study will also examine the immune response to the vaccine and its effectiveness in regressing HSIL. Volunteers would be eligible to enroll in the study if they have had a recent Papanicolaou (Pap) smear result indicating HSIL or "Cannot rule out HSIL", and if they meet the inclusion/exclusion criteria. Subjects will be eligible to receive vaccinations if biopsy confirms HSIL. A series of four vaccinations will be given roughly 3 weeks apart, and LEEP will be performed at the end of the study approximately 12 weeks after the last vaccination.
University of Arkansas is the lead sponsor of 398 studies on the registry; 37 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 34 (92%) have results posted.
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Exclusion Criteria:
an escalating dose study of a vaccine consisting of four HPV-16 E6 peptides in combination with Candin® to determine the clinically optimum dose (COD), immunologically optimal dose (IOD), and maximum tolerated dose (MTD). An additional 30 subjects will be vaccinated at the final dose (apparent COD) for further assessment of clinical response.
Biological: Vaccine consisting of four HPV-16 E6 peptides in combination with Candin®
safety
real-time safety measurement of the combined administration of HPV vaccine and Candin® as measured by dose limiting toxicity as defined by adverse events; safety will be assessed at time of vaccination, 30 minutes post-injection, and daily for 7 days post injections.
Time frame: immediately then up to 7 days post vaccinations
clinical and virological/immunological response to the HPV vaccine
Clinical response as defined by loop electrical excision procedure (LEEP); virological assessment to assess the clearance of HPV infection after vaccination; immunological assessments of T-Cells and circulating immune cells (regulated T-Cells and myeloid derived suppressor cells); and assessment of cervical immune cells.
Time frame: within weeks of vaccinations or procedures
The record gives a start of Aug 2012, a primary completion of Jul 2015 and a completion of Jul 2015. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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