A Phase I efficacy and safety study of HPV16-specific therapeutic DNA-Vaccinia vaccination in combination with topical imiquimod, in patients with HPV16 high grade cervical dysplasia (CIN2/3)
Cornelia (Connie) Trimble
Purpose Cervical dysplasia is caused by infection with a common virus, human papillomavirus (HPV). This study will test safety and tolerability of therapeutic vaccines designed to make an immune response against HPV16, the strain most commonly associated with cervical dysplasia. We will also look at effects in cervical tissue.
-Females over age 18 with HPV16+ CIN3 -Immune competent
Subjects in the first three treatment groups will get vaccinated with experimental vaccines, pNGVL4a-sig/E7(detox)/HSP70, and TA-HPV, before having a cone or LEEP procedure at week 15. Subjects in treatment group 4 will get imiquimod, which is a cream for enhancing immune responses, applied directly to the lesion, before having a cone or a LEEP procedure at week 15. Subjects in treatment group 5 will get vaccinated and also have the cream on their cervix, before having a cone or a LEEP procedure at week 15. There are study specific blood samples and cervical swabs collected before and after vaccination, and at the time of surgery. The vaccines and the cream are provided in this trial.
03/13/2014 04:02 AM