Clinical Research Directory

Phase I/II Trial of Electroporation-Delivered pBI-4 Vaccine (TriGrid™ PVX4) for Treatment of Women With HPV16-Positive CIN1 or Persistent Infection

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.

Adjuvant 5-Fluorouracil Following Thermal Ablation to Improve HPV Treatment Outcomes in Women With HIV in Kenya

This randomized, placebo-controlled trial will evaluate self-administered 5-fluorouracil (5FU) to improve human papillomavirus (HPV) clearance after thermal ablation (TA) in Women With Human Immunodeficiency Virus (HIV) (WWH) in Kenya. The trial will also assess the safety, adherence, and acceptability of 5FU. Starting four weeks after TA, participants will self-administer 5FU cream or matched placebo intravaginally once every other week for 12 applications, with clinic visits at weeks 2, 8, 16, 24, and 48 for evaluation. All participants will be followed up to 48 weeks. It is hypothesized that, compared to placebo, 5FU will increase HPV clearance at 24 weeks and that the proposed dosing schedule will be safe, well-tolerated, and acceptable in this population. Together with data from other studies, this trial will provide evidence on the use of self-administered intravaginal 5FU to improve HPV treatment outcomes in WWH in low- and middle-income countries, where the burden of cervical cancer is highest.