Loading clinical trials...

Assessing Jet Administration of pBI-11 for the Treatment of Patients With HPV16/18+ | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE2

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

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

NCT06210854•Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

View on ClinicalTrials.gov

Summary

This is a randomized phase II study. The primary goal of this study is to determine the safety and tolerability of three monthly pBI-11 DNA administrations in each thigh of patients with persistent human papillomavirus 16 (HPV16) and/or human papillomavirus (HPV18+).

Detailed Description

This is a randomized phase II study. The primary goal of this study is two-fold; one is to determine the safety and tolerability of three monthly pBI-11 DNA administrations in each thigh of patients with persistent HPV16 and/or HPV18+ \< cervical intraepithelial neoplasia 2 (CIN2), wherein either 0.1 mL (0.3 mg) of the plasmid DNA is administered intradermally (I.D.) into each thigh (for a total of 0.6 mg DNA at each visit) using a Pharmajet Tropis device, or 0.5 mL (1.5 mg) of the plasmid DNA is administered intramuscularly (I.M.) into each thigh (for a total of 3 mg DNA at each visit) using a Pharmajet Stratis device; and the other is to evaluate the effect of vaccine on (HPV16/18) viral DNA clearance. Secondary goals are to seek preliminary evidence of prevention of disease progression and assess induction of an HPV16/18-specific immune response to select the appropriate regimen for a subsequent phase III clinical trial. Persistence is defined as positivity on two sequential tests. A total of 72 participants will be enrolled in 4 arms of the study in a 2:1:2:1 ratio (24 patients randomized to the intervention and 12 patient randomized to placebo via Tropis device, and 24 patients randomized to the intervention and 12 patient randomized to placebo via Stratis device).

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•1. Patients must have:
•Negative for Intraepithelial Lesions (NEIL), Atypical Squamous Cells of Undetermined Significance (ASC-US), or Low-grade Squamous Intraepithelial Lesion (LSIL) determined by cervical cytology
•AND
•HPV16 and/or 18+ by Roche Cobas 4800, Roche Linear Array HPV Genotyping test, or other FDA-approved HPV genotyping test (Co-infections with HPV types other than HPV16/18 are permissible).
•2. Age ≥ 18 years
•3. Baseline Eastern Cooperative Oncology Group performance status of 0, 1 at the time of treatment administration.
•4. Patients must have adequate organ function at the time of enrollment as defined by the following parameters:
•* White blood cell count ≥ 3,000
•* Absolute lymphocyte number ≥ 500
•* Absolute neutrophil count ≥ 1,500
+8 more criteria

Exclusion Criteria

•1. Histologic evidence of CIN2, cervical intraepithelial neoplasia 3 (CIN3), adenocarcinoma in situ or malignancy.
•2. Patients with a diagnosis of immunosuppression or active systemic use of immunosuppressive medications such as steroids.
•3. Patients who are receiving any other investigational agents within 28 days prior to the first dose.
•4. Patients with an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
•5. Patients with a history of systemic autoimmune disease such as multiple sclerosis or systemic lupus erythematosus (SLE), but exclusive of a history of thyroiditis, psoriasis, Sjrogen's, or inflammatory bowel disease.
•6. Patients who are pregnant or breast feeding or plan to become pregnant within five months of first study treatment.
•7. Patient with active infection of, or receiving treatment for Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV), or Hepatitis B Virus (HBV).
•8. History of prior malignancy with disease free interval \<5 years; however, individuals with completely resected basal cell or squamous cell carcinoma of the skin within this interval may be enrolled.

Key Dates

Start Date

May 1, 2026

Primary Completion Date

March 1, 2028

Completion Date

October 1, 2028

Last Updated

October 23, 2025

Enrollment

ESTIMATED participants

Conditions

HPV Infection

Interventions

pBI-11

DRUG

Contacts

Kimberly Levinson, MD

CONTACT

410-955-8240 klevins1@jhmi.edu

Ashish Solanki, RN

CONTACT

410-614-6702 asolank2@jhmi.edu

Clinic vs Clinic+Community Outreach HPV Self-Collection to Increase Cervical Screening in Women With HIV

NCT07428330

Cervix CancerHIV Infections+1 more

View study

RECRUITINGNA

Implementation of Screen, Treat, and Triage for Women Living With HIV in La Romana (iSTAR)

NCT07225530

HIV InfectionsHPV Infection+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 23, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Clinic vs Clinic+Community Outreach HPV Self-Collection to Increase Cervical Screening in Women With HIV

Implementation of Screen, Treat, and Triage for Women Living With HIV in La Romana (iSTAR)

To Evaluate the Safety and Immunogenicity of 15-valent HPV Recombinant Vaccine in Chinese People Aged 9-45 Years

HPV DNA Self-sampling in a General Practitioner's Office.

Immunogenicity and Safety of Quadrivalent HPV Vaccine in Healthy Chinese Female Subjects Aged 9 to 19 Years

Concomitant HPV Vaccination and HPV Screening HPV Infection and Cervical Cancer in Sweden