A Pilot Study of pNGVL4a-CRT/E7(detox) for the treatment of patients with HPV16+ Cervical Intraepithelial Neoplasia 2/3 (CIN2/3)
Cornelia (Connie) Trimble
Cervical dysplasia is caused by infection with a common virus, human papillomavirus (HPV). This study will test immunogenicity of three different routes of administration of a therapeutic vaccine designed to make an immune response against HPV16, the strain most commonly associated with cervical dysplasia. We will also study immunologic markers in cervical tissue.
Females over age 18 with HPV16+ CIN2/3 Immune competent
Subjects in the first two treatment groups will get vaccinated with experimental vaccine pNGVL4a-CRT/E7(detox) via needle-free particle mediated epidermal delivery (PMED) administration, before having a cone or LEEP procedure at week 15. Subjects in treatment groups 3 and 4 will get vaccinated with pNGVL4a-CRT/E7(detox) intramuscularly, before having a cone or a LEEP procedure at week 15. Subjects in treatment groups 5 and 6 will get vaccinated with pNGVL4a-CRT/E7(detox) directly into the lesion, 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 vaccine is provided free of charge to patients in this trial.
05/24/2013 04:02 AM