NCT07454915

Brief Summary

The purpose of this Phase 2 study is to compare the effects of administering the PVX4 combination device biologic product (pBI-4 DNA vaccine via electroporation-mediated intramuscular delivery with the TriGridâ„¢ Delivery System) in patients with biopsy-confirmed, human papilloma virus (HPV) 16-associated high grade cervical intraepithelial neoplasia (CIN2/3) as compared to the administration of placebo.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
138

participants targeted

Target at P75+ for phase_2

Timeline
23mo left

Started Apr 2026

Geographic Reach
2 countries

10 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress10%
Apr 2026Jun 2028

First Submitted

Initial submission to the registry

February 27, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 6, 2026

Completed
26 days until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Last Updated

May 6, 2026

Status Verified

April 1, 2026

Enrollment Period

1.7 years

First QC Date

February 27, 2026

Last Update Submit

May 3, 2026

Conditions

Cervical Intraepithelial Neoplasia Grade 2/3Human Papilloma Virus Infection Type 16

Keywords

Human papilloma virusHPV16HSILCIN 2/3DNA vaccineCervical intraepithelial neoplasia

Outcome Measures

Primary Outcomes (1)

  • Proportion of subjects exhibiting virological clearance of HPV16 and histopathological regression of cervical lesions to < CIN2 at Month 6

    The proportion of subjects with histopathologically confirmed HPV16 associated CIN2 or CIN 3 who exhibit virological clearance of HPV16 and regression of cervical lesions to \< CIN 2 at Month 6.

    Month 6

Secondary Outcomes (2)

  • Sustained virological clearance of HPV16

    Month 12

  • TDS-IM v2.0 Device Reliability

    Week 0, 4, and 8

Study Arms (2)

Active

EXPERIMENTAL

PVX4 (pBI-4 DNA vaccine administered via the Intramuscular TriGrid Electroporation Delivery System version 2.0)

Combination Product: PVX4 Combination Product

Placebo

PLACEBO COMPARATOR

Sodium Chloride 0.9% for injection administered via the Intramuscular TriGrid Electroporation Delivery System version 2.0

Other: Placebo Control

Interventions

PVX4 Combination ProductCOMBINATION_PRODUCT

pBI-4 DNA vaccine (1.0 mg) administered by electroporation mediated intramuscular injection via the TriGrid Delivery System version 2.0 (TDS-IM v2.0)

Active
Placebo ControlOTHER

0.9% Saline for injection (1.0 mL) administered by electroporation mediated intramuscular injection via the TriGrid Delivery System version 2.0 (TDS-IM v2.0)

Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Female subjects 18-60 years old with biopsy-confirmed high grade cervical intraepithelial neoplasia (CIN2/3) confirmed by central review.
  • Patients whose cytobrush samples are HPV16+ by Roche Cobas genotyping test. Co-infections with HPV types other than HPV16 are permissible for study entry
  • HIV negative
  • Patients who are able and willing to comply with all study procedures, and with anticipated availability for the planned follow-up period of one year
  • Patients who are of childbearing potential agree to remain sexually abstinent, use methods of contraception (e.g. oral contraception, barrier methods, spermicide, intrauterine device (IUD)), or have a partner who is sterile (i.e., vasectomy) through 6 months.
  • Patients must have adequate organ function at the time of enrollment as defined by the following parameters: white blood cell count \>3,000/mcL; lymphocyte number \>500/mcL; absolute neutrophil count \>1,000/mcL; platelets \>90,000/mcL; hemoglobin \>9 g/dL; total bilirubin \<3 X the institutional limit of normal; aspartate aminotransferase (AST \[SGOT\]) / alanine aminotransferase (ALT \[SGPT\]) \<3 X the institutional limit of normal; creatinine \<2.5X the institutional limit of normal.

You may not qualify if:

  • Patients who are attempting pregnancy within 6 months, pregnant, or breastfeeding.
  • Patients with immunodeficiency, or treatment with immunosuppressive medications
  • Administration of any blood product within 3 months of enrollment.
  • Administration of any licensed vaccine within 2 weeks of enrollment (4 weeks for a live vaccine)
  • Participation in a study with an investigational compound or device within 30 days of signing informed consent.
  • History of seizures (unless seizure free for 5 years)
  • Previous cancer history within the past 5 years, except localized skin cancer.
  • Patients who have had chemotherapy, radiation, biological cancer therapy, or other investigational agents within 28 days prior to the first dose of study drug.
  • Patients who have had surgery within 28 days, excluding minor procedures (dental work, skin biopsy, etc).
  • 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.
  • Patients who have an active autoimmune disease (e.g., rheumatoid arthritis, systemic lupus erythematosus (SLE), ulcerative colitis, Crohn's Disease, multiple sclerosis (MS), ankylosing spondylitis).
  • Previous cervical conization or LEEP procedure or previous total hysterectomy due to cervical lesions at enrollment
  • High-grade intraepithelial lesions (CIN2/3) encompassing more than 180-degree (more than 2 quarters) of cervix
  • Positive HBV PCR if Hepatitis B surface antigen positive
  • Positive HCV PCR if anti-HCV positive
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Montefiore Medical Center

The Bronx, New York, 10467, United States

NOT YET RECRUITING

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung, Taiwan, 83301, Taiwan

NOT YET RECRUITING

China Medical University Hospital

Taichung, Taiwan, 40447, Taiwan

NOT YET RECRUITING

Taichung Veterans General Hospital

Taichung, Taiwan, 40705, Taiwan

NOT YET RECRUITING

National Cheng Kung University Hospital

Tainan, Taiwan, 70403, Taiwan

NOT YET RECRUITING

National Taiwan University Hospital

Taipei, Taiwan, 100225, Taiwan

NOT YET RECRUITING

MacKay Memorial Hospital

Taipei, Taiwan, 10449, Taiwan

NOT YET RECRUITING

Taipei Medical University Hospital

Taipei, Taiwan, 11031, Taiwan

NOT YET RECRUITING

Taipei Veterans General Hospital

Taipei, Taiwan, 11217, Taiwan

NOT YET RECRUITING

Linkou Chang Gung Memorial Hospital

Taoyuan, Taiwan, 33305, Taiwan

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Dysplasia

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2026

First Posted

March 6, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

June 1, 2028

Last Updated

May 6, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

The primary considerations regarding the determination not to share individual patient data (IPD) are the related to the proprietary commercial development of the candidate and protection of participant privacy and confidentiality. The data collected in this study are considered proprietary and confidential commercial information. Sharing of IPD would pose a risk to the sponsor's clinical development efforts in the competitive marketplace. Aggregate study results will be made available through summary results reporting and peer-reviewed publications. In addition, the sharing of IPD (even when deidentified) poses a potential risk of re-identification, especially given the relatively small patient population being studied.

Locations

TW(9)US(1)