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.
Patients with CIN1 on biopsy and whose cytologic sample is HPV16+ by Roche Cobas test in the past 30 days, OR patients with CIN<1 on biopsy whose cytologic sample is HPV16+ by Roche Cobas test in the past 30 days and a history of a second HPV16+ test at least 6 months prior
(Co-infections with HPV types other than HPV16 are permissible for study entry)
Age ≥ 19 years
Baseline Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at the time of study treatment administration
Patients with AIS (adenocarcinoma in situ) or cancer determined by cervical cytology at study entry
Histologic evidence of CIN2 or above
Patients with a diagnosis of immunosuppression or prolonged, active use of immunosuppressive medications such as steroids
Prior treatment with any HPV therapeutic agent (e.g., Imiquimod, Veregen, Podophylotoxin)
Parallel
pBI-4 Vaccine
Biological/VaccineA clinical-grade, 6,999 base-pair circular recombinant plasmid DNA vaccine (pBI-4) engineered to express human calreticulin (CRT) linked to codon-optimized HPV16 E6, E7, and L2 residues (amino acids 11-200). To ensure clinical safety, E6 and E7 incorporate inactivating mutations to disable their native oncogenic transforming activities. Administered at a dose of 1.0 mg (1.0 mL) intramuscularly into the thigh muscle using the TDS-IM v2.0 electroporation device.
Proportion of subjects exhibiting virological clearance of HPV16 and histopathological regression of cervical lesions to < CIN2 at Month 6
The proportion of subjects with histopathologically confirmed HPV16-associated CIN2 or CIN3 who exhibit virological clearance of HPV16 and regression of cervical lesions to \< CIN2 at Month 6.
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