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

NCT06210854 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2026-03-24

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • PapiVax Biotech, Inc.

    collaborator OTHER

  • National Cancer Institute (NCI)

    collaborator NIH

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    lead OTHER

Principal Investigators

  • Kimberly Levinson, MD · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2029-03-01
Completion
2030-03-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06210854 on ClinicalTrials.gov