Trial intelligence / Profile preview

pBI-11 DNA Vaccine for HPV16/18+ <CIN2

NCT06210854Phase 2

Key facts

Status: Recruiting
Start: Jun 2026
Primary completion: Nov 2028
Countries: 1
Sponsor: Sidney Kimmel Comprehensive Cancer Center
Modality: Prophylactic Vaccines, Therapeutic Vaccines, DNA Vaccines

Drugs: pBI-11
Conditions: human papillomavirus infection

Overview

Phase 2, randomised, double-blind trial in human papillomavirus infection comparing Arm 1: pBI-11 + pBI-11 + pBI-11 with Arm 2: Placebo + Placebo + pBI-11 (2 arms). Primary endpoints: Frequency and Severity Local Adverse Events and Abnormalities at 12 months, Frequency and Severity Systemic Adverse Events and Abnormalities at 12 months and 7 more. Started Jun 2026; status: recruiting.

Design

2 arms

Study design: RandomizedDouble-blind

Arm 1: pBI-11 + pBI-11 + pBI-11
3 doses of pBI-11 at Day 0, Week 4, Month 7
Arm 2: Placebo + Placebo + pBI-11
2 doses of placebo at Day 0, Week 4, and 1 dose of pBI-11 at Month 7

Who it enrols

Women >= 18 years with persistent HPV16 and/or 18+ cervical infection, negative for high-grade intraepithelial lesions (<CIN2), with adequate organ function. Excludes patients with immunosuppression, active HIV/HCV/HBV, pregnancy, or metal implants at the injection site.

Endpoints

Primary

Frequency and Severity Local Adverse Events and Abnormalities12 months
Frequency and Severity Systemic Adverse Events and Abnormalities12 months
Frequency and Severity Solicited Local Adverse Events and Abnormalities7 days
Frequency and Severity Solicited Systemic Adverse Events and Abnormalities7 days
Pain Scores assessed by Visual Analog Scale7 months

Secondary

Effect of 3 doses of pBI-11 on HPV16/18 clearance - Percentage of Participants that Exhibit HPV16/18 Positivity (Active arm)12 months
Effect of 1 dose of pBI-11 on HPV16/18 clearance - Percentage of participants that exhibit HPV16/18 positivity (Placebo arm)12 months
Levels of HPV16/18 E6/E7-specific T cellsWeek 8
Changes in Cytopathology12 months

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