Study on Using pBI-11 DNA Vaccine with Electroporation for Treating HPV16/18+ Infections

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Sponsor score: 60

ClinicalTrials ID:NCT06210854

Provider View

This clinical trial is testing a new DNA vaccine called pBI-11 to see if it is safe and effective for women with persistent HPV16 or HPV18 infections, which can lead to cervical cancer. The vaccine is given using a special device that helps deliver it into the muscle.

Patient Parameters

Program Overview

The purpose of this study is to test the safety and effectiveness of a new DNA vaccine, pBI-11, for women with ongoing infections of HPV types 16 and 18, which are linked to cervical cancer. The vaccine aims to boost the immune system to fight these viruses. Participants will receive either the pBI-11 vaccine or a placebo through a device that helps inject it into the muscle.

Description

This study is a Phase II trial where participants are randomly assigned to receive either the pBI-11 DNA vaccine or a placebo. The vaccine is given twice, four weeks apart, using a device that helps deliver it into the muscle. The main goals are to check if the vaccine is safe, if it helps clear the HPV16/18 virus, and if the delivery device works well. Participants will be monitored for any side effects and the effectiveness of the vaccine in reducing the virus.

Eligibility Criteria

Inclusion Criteria

  • Women with no significant cervical lesions as determined by a Pap test.
  • Positive for HPV16 and/or HPV18 based on specific lab tests.
  • Aged 18 years or older.
  • Good overall health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Adequate blood cell counts and organ function as determined by specific blood tests.
  • Women of childbearing potential must agree to use effective contraception during the study and for three months after the last vaccination.
  • Ability to understand and agree to the study requirements, including signing a consent form and attending all study visits.

Exclusion Criteria

  • Evidence of more severe cervical changes or cancer.
  • Current use of medications that suppress the immune system.
  • Participation in another clinical trial within 28 days before the first vaccine dose.
  • Uncontrolled medical conditions or psychiatric issues that could interfere with the study.
  • History of autoimmune diseases, except for certain conditions like thyroiditis or psoriasis.
  • Pregnant or breastfeeding women, or those planning to become pregnant within a year of starting the study.
  • Allergies to components similar to the pBI-11 vaccine.
  • Active infections like HIV, Hepatitis B, or Hepatitis C.
  • History of cancer within the last five years, except for certain skin cancers.
  • Metal implants or electronic devices in the body that could interfere with the vaccine delivery.
  • Neurological disorders, except for certain conditions like a single childhood seizure.
  • Recent fainting episodes without a clear cause.
  • Recent use of blood products or immunoglobulins.
  • Physical conditions that prevent proper observation of the injection site.

Locations

FACILITYZIPCITYSTATE
University of Alabama at Birmingham35249BirminghamAlabama
Johns Hopkins University21287BaltimoreMaryland

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