The purpose of this study is to evaluate the safety, efficacy, and tolerability of pBI-4, an investigational therapeutic DNA vaccine, in treating adult women with Human Papillomavirus type 16 (HPV16)-positive Grade 1 cervical intraepithelial neoplasia (CIN1) or persistent HPV16 infection.
This is a randomized, double-blind, placebo-controlled, multicenter Phase II trial in Taiwan, aiming to enroll a total of 94 female participants. Participants will be randomly assigned (1:1 ratio) to receive either a single 1.0 mg dose of the pBI-4 vaccine or a placebo. The study drug or placebo will be administered intramuscularly in the thigh muscle using the TriGrid™ Delivery System version 2.0 (TDS-IM v2.0), a specialized device that applies short, mild electrical pulses (electroporation) to help cells take up the vaccine and stimulate a stronger immune response.
The primary goal of the study is to compare the rate of HPV16 viral clearance between the vaccine and placebo groups at Month 6. The study also features an adaptive design: an interim analysis will be conducted after approximately 50% of participants complete their 6-month assessment. If the initial single-dose regimen shows suboptimal efficacy at the interim stage, the trial may adaptively switch to a two-dose (prime-boost) regimen administered one month apart for the remaining participants. All participants will be closely monitored for safety, side effects, and immune responses for a total duration of 12 months.