Evaluation of VGX-3100 and Electroporation Alone or in Combination With Imiquimod for the Treatment of HPV-16 and/or HPV-18 Related Vulvar HSIL (Also Referred as: VIN 2 or VIN 3)
A Phase 2, Randomized, Open Label, Efficacy Study of VGX-3100 Delivered Intramuscularly Followed by Electroporation With CELLECTRA™ 2000 Alone or in Combination With Imiquimod, for the Treatment of HPV-16 and/or HPV-18 Related High Grade Squamous Intraepithelial Lesion (HSIL) of the Vulva
Doctors at the NIH Clinical Center seek patients with vulvar high-grade squamous intraepithelial lesion (HSIL) to trial a therapeutic DNA vaccine. This vaccine is a loop of selected DNA from the human papilloma virus which is known to cause vulvar cancers. The body’s cells uses the genes to produce proteins that prompt the body to attack vulvar cancer cells, killing the cancer. Additionally, these conditions are eligible:
- Vulvar High Grade Squamous Intraepithelial Lesion (HSIL)
- Vulvar Dysplasia
- Vulvar Intraepithelial Neoplasia (VIN)
- Pre-cancerous Lesions of the Vulva
- Human Papillomavirus (HPV)
Study participants will receive intramuscular injections 4 times over 24 weeks, along with a therapy that causes the muscle cells to better absorb the vaccine. Half the participants will also apply a topic cream during the study, and all will be followed for a total of 100 weeks.
- Be female, age 18 or older
- Not be pregnant or breastfeeding
- Have high grade squamous intraepithelial lesion (HSIL) of the vulva (VIN2 or VIN3) caused by infection with HPV types 16 and/or 18 confirmed at screening visit
THE STUDY INVOLVES:
- Screening to confirm acceptance to the study.
- Intramuscular injection of the therapy or placebo, with CELLECTRA™-5PSP electric muscle stimulation to enhance absorption of the vaccine
- Repeat of step (2) at 4 weeks, 12 weeks, and 24 weeks
- A portion of participants will also apply a topical cream 3 times per week for 20 weeks.
- Follow up with lab and physical assessments for up to 100 weeks.
LOCATIONS & CONTACTS:
Contact: Inovio Call Center | 267-440-4237 | [email protected]
21 study locations are participating in this large trial. See all locations here.
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