Phase II Randomized Double-Blind Study of pBI-11 DNA Vaccine Delivered by Electroporation to Treat Women With Persistent HPV16 or HPV18 Cervical Infection

What this Trial Is About

Researchers are evaluating the safety and feasibility of a DNA vaccine called pBI-11 in women with persistent infections of human papillomavirus types 16 andor 18 HPV1618, viruses linked to cervical cancer. This randomized, double-blind, placebo-controlled phase II trial uses a crossover design to study the vaccines effects on clearing HPV1618 viral DNA and to assess the reliability of the delivery device. Participants will receive either three doses of the pBI-11 vaccine or two doses of placebo followed by one dose of pBI-11. The vaccine and placebo are given intramuscularly using the TriGrid Delivery System at Day 0, Week 4, and Month 7. The study monitors participants for safety, vaccine acceptability, viral DNA clearance, and device performance over approximately 12 months. Throughout the study, participants will undergo evaluations including monitoring for local and systemic adverse events, pain assessments, and surveys on vaccine acceptability. Researchers will also test for HPV1618 viral DNA clearance, immune response through T cell levels, cytopathology changes, and track device reliability. The total participation duration spans up to one year with scheduled follow-ups after each vaccination.

Assessing Administration of pBI-11 Via Electroporation for the Treatment of Patients With HPV16/18+