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New treatment option for HPV Infection
Official title Assessing Administration of pBI-11 Via Electroporation for the Treatment of Patients With HPV16/18+
ClinicalTrials.gov ID: NCT06210854
What this study is testing
What is pBI-11 (3 doses)?
pBI-11 (3 doses) is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for hpv infection.
Also referred to as pBI-11 plasmid DNA.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Negative for Intraepithelial Lesions (NEIL), Atypical Squamous Cells of Undetermined Significance (ASC-US), or Low-grade Squamous Intraepithelial...
- 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...
- Age ≥ 18 years
- Baseline Eastern Cooperative Oncology Group performance status of 0 or 1 at the time of enrollment.
- Patients must have adequate organ function at the time of enrollment as defined by the following parameters:
You likely can't join if
- Histologic evidence of CIN2, cervical intraepithelial neoplasia 3 (CIN3), adenocarcinoma in situ or malignancy.
- Patients with a diagnosis of immunosuppression or active systemic use of immunosuppressive medications such as steroids.
- Patients who are receiving any other investigational agents within 28 days prior to the first dose of study vaccine.
- Patients with an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure...
- Patients with a history of systemic autoimmune disease such as multiple sclerosis or systemic lupus erythematosus (SLE), but exclusive of a history...
- Patients who are pregnant or breast feeding or plan to become pregnant within 12 months of first study treatment.
See the full eligibility criteria
- 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).
- Age ≥ 18 years
- Baseline Eastern Cooperative Oncology Group performance status of 0 or 1 at the time of enrollment.
- Patients must have adequate organ function at the time of enrollment as defined by the following parameters:
- White blood cell count ≥ 3,000 cells/uL
- Absolute lymphocyte number ≥ 500 cells/uL
- Absolute neutrophil count ≥ 1,500 cells/uL
- Platelets ≥ 90,000 cells/uL
- Hemoglobulin ≥ 9 g/dL
- Total bilirubin \< 3 X the institutional limit of normal
- Aspartate Aminotransferase (AST) and Alanine Aminotransferase(ALT) \< 3 X the institutional limit of normal
- Creatinine \< 2.5 X the institutional limit of normal
- Women of child-bearing potential must agree to use long acting contraception (e.g. tubal ligation, intrauterine device or hormonal implant) or two forms of contraception (e.g. barrier method, oral contraceptives) prior...
- Ability to understand and the willingness to sign a written informed consent document.
- Able to adhere to the study visit schedule and other protocol requirements.
- Histologic evidence of CIN2, cervical intraepithelial neoplasia 3 (CIN3), adenocarcinoma in situ or malignancy.
- Patients with a diagnosis of immunosuppression or active systemic use of immunosuppressive medications such as steroids.
- Patients who are receiving any other investigational agents within 28 days prior to the first dose of study vaccine.
- 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...
- 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, Sjogren's, or inflammatory bowel disease.
- Patients who are pregnant or breast feeding or plan to become pregnant within 12 months of first study treatment.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to pBI-11 DNA vaccine.
- Patient with active infection of, or receiving treatment for Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV), or Hepatitis B Virus (HBV).
- 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.
- Participants with metal implant(s) at the site of injection or any electronic stimulation device, such as cardiac demand pacemakers, automatic implantable cardiac defibrillator, nerve stimulators, or deep brain...
- Participants with any chronic or active neurologic disorder, including seizures and epilepsy, excluding a single febrile seizure as a child or episode of seizure in pregnancy due to eclampsia.
- Participants with syncopal episode within 12 months of screening, excluding fainting for a known and unrelated cause such as anemia which has been resolved.
- Administration of immunoglobulins and/or any blood products within the 120 days preceding study entry or planned administration during the study period.
- Participants with a skin-fold measurement of the cutaneous and subcutaneous tissue for all eligible injection sites (vastus lateralis muscles with intact lymph drainage) exceeds 50 mm.
- Participants in whom the ability to observe possible local reactions at the injection site (lateralis region) is, in the opinion of the investigator, unacceptably obscured due to a physical condition or permanent body...
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Baltimore, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Baltimore, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.