RecruitingPhase 2NCT06210854

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


Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Enrollment

48 participants

Start Date

Jun 25, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called Placebo (2 doses), a biological treatment called pBI-11 (1 dose), and others for people with hpv infection. The study is currently recruiting participants at 2 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALpBI-11 (3 doses)

pBI-11 at Day 0, Week 4, Month 7

BIOLOGICALpBI-11 (1 dose)

pBI-11 at Month 7

BIOLOGICALPlacebo (2 doses)

Placebo (saline) vaccine at Day 0, Week 4


Locations(2)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Johns Hopkins University

Baltimore, Maryland, United States

View Full Details on ClinicalTrials.gov

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NCT06210854


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