NCT06210854

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

Double-Blind Randomized Phase II Clinical Trial Assessing Administration of pBI-11 Via Electroporation for the Treatment of Patients With HPV16/18+ <CIN2

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research is being done to test the safety and feasibility of an investigational DNA vaccine called pBI-11 and to find out what effects, if any, it has on women with persistent human papillomavirus 16 (HPV16+) and/or human papillomavirus (HPV18+) cervical infection. The DNA vaccine is designed to promote an immune response to treat disease caused by HPV types 16 and 18, viruses that can cause cervical cancer. The pBI-11 DNA vaccine or a placebo will be administered intramuscularly using the TriGridTM Delivery System.

Detailed description

This is a randomized double-blind placebo-controlled phase II study with cross-over design. The primary goal of this study is three-fold; one is to determine the safety and feasibility of two pBI-11 DNA administrations four weeks apart in patients with persistent HPV16 and/or HPV18+ \<CIN2, wherein 3.0 mg of the plasmid DNA is delivered via electroporation mediated intramuscular (IM) administration with the TriGrid Delivery System version 2.0 (TDS-IM v2.0); to evaluate the effect of vaccine on HPV16/18 viral DNA clearance; to evaluate the reliability of the device.

Conditions

• HPV Infection

Interventions

Type	Name	Description
BIOLOGICAL	pBI-11 (3 doses)	pBI-11 at Day 0, Week 4, Month 7
BIOLOGICAL	pBI-11 (1 dose)	pBI-11 at Month 7
BIOLOGICAL	Placebo (2 doses)	Placebo (saline) vaccine at Day 0, Week 4

Timeline

• Start date: 2026-05-01
• Primary completion: 2029-03-01
• Completion: 2030-03-01
• First posted: 2024-01-18
• Last updated: 2026-03-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study