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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study ID
NCT06210854
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • HPV Infection

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • pBI-11 (3 doses) — BIOLOGICAL
    pBI-11 at Day 0, Week 4, Month 7
  • pBI-11 (1 dose) — BIOLOGICAL
    pBI-11 at Month 7
  • Placebo (2 doses) — BIOLOGICAL
    Placebo (saline) vaccine at Day 0, Week 4

Study Details

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.

Key Dates

First listed
Jan 18, 2024
Start date
Jun 25, 2026
Status verified
Jun 2026
Primary completion
Nov 30, 2028
Completion
May 31, 2029

Study Design

Enrollment
48 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1: pBI-11 + pBI-11 + pBI-11
    Will receive 3 doses of pBI-11 using the TriGrid Delivery System.
  • Experimental: Arm 2: Placebo + Placebo + pBI-11
    Will receive 2 doses of placebo and 1 dose of pBI-11 using the TriGrid Delivery System

Primary Outcome Measure

Safety - Frequency and Severity Local Adverse Events and Abnormalities [ Time Frame: Post-first study vaccination up to 12 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35249
Rebecca Arend, MD
[email protected]
Rebecca Arend, MD (PRINCIPAL_INVESTIGATOR)
Johns Hopkins UniversityBaltimoreMaryland21287
Kimberly Levinson, MD
[email protected]
Kimberly Levinson, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham· Birmingham, ALJohns Hopkins University· Baltimore, MD

Related Studies