PVX4 for the Treatment of Human Papilloma Virus (HPV)16+ Cervical Dysplasia

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 TriGrid™ 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.

Study Overview

• Status: Recruiting
• Conditions: Cervical Intraepithelial Neoplasia Grade 2/3; Human Papilloma Virus Infection Type 16
• Intervention / Treatment: Combination product: PVX4 Combination Product; Other: Placebo Control

• Study Type: Interventional
• Enrollment (Estimated): 138
• Phase: Phase 2

Contacts and Locations

Study Locations

• Taiwan
  • Taiwan
    • Kaohsiung, Taiwan, Taiwan, 83301
      • Not yet recruiting
      • Kaohsiung Chang Gung Memorial Hospital
      • Principal Investigator: Chen-Hsuan Wu, MD
    • Taichung, Taiwan, Taiwan, 40447
      • Not yet recruiting
      • China Medical University Hospital
      • Principal Investigator: Lian-Shung Yeh, MD
    • Taichung, Taiwan, Taiwan, 40705
      • Not yet recruiting
      • Taichung Veterans General Hospital
      • Principal Investigator: Shih-Tien Hsu, MD
    • Tainan, Taiwan, Taiwan, 70403
      • Not yet recruiting
      • National Cheng Kung University Hospital
      • Principal Investigator: Pei-Ying Wu, MD
    • Taipei, Taiwan, Taiwan, 100225
      • Not yet recruiting
      • National Taiwan University Hospital
      • Principal Investigator: Yu-Li Chen, MD
    • Taipei, Taiwan, Taiwan, 10449
      • Not yet recruiting
      • MacKay Memorial Hospital
      • Principal Investigator: Chih-Long Chang, MD
    • Taipei, Taiwan, Taiwan, 11031
      • Not yet recruiting
      • Taipei Medical University Hospital
      • Principal Investigator: Jiantai Timothy Qiu, MD
    • Taipei, Taiwan, Taiwan, 11217
      • Not yet recruiting
      • Taipei Veterans General Hospital
      • Principal Investigator: Yi-Jen Chen, MD
    • Taoyuan, Taiwan, Taiwan, 33305
      • Recruiting
      • Linkou Chang Gung Memorial Hospital
      • Principal Investigator: Chyong-Huey Lai, MD
      • Contact: Clinical Trial Office; Phone Number: 8254 +886 3 3281200; Email: ray557722@gmail.com
• United States
  • New York
    • The Bronx, New York, United States, 10467
      • Not yet recruiting
      • Montefiore Medical Center
      • Principal Investigator: Juan D Quniones, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Female subjects 18-60 years old with biopsy-confirmed high grade cervical intraepithelial neoplasia (CIN2/3) confirmed by central review.
2. Patients whose cytobrush samples are HPV16+ by Roche Cobas genotyping test. Co-infections with HPV types other than HPV16 are permissible for study entry
3. HIV negative
4. 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
5. 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.
6. 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.

Exclusion Criteria:

1. Patients who are attempting pregnancy within 6 months, pregnant, or breastfeeding.
2. Patients with immunodeficiency, or treatment with immunosuppressive medications
3. Administration of any blood product within 3 months of enrollment.
4. Administration of any licensed vaccine within 2 weeks of enrollment (4 weeks for a live vaccine)
5. Participation in a study with an investigational compound or device within 30 days of signing informed consent.
6. History of seizures (unless seizure free for 5 years)
7. Previous cancer history within the past 5 years, except localized skin cancer.
8. Patients who have had chemotherapy, radiation, biological cancer therapy, or other investigational agents within 28 days prior to the first dose of study drug.
9. Patients who have had surgery within 28 days, excluding minor procedures (dental work, skin biopsy, etc).
10. 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.
11. 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).
12. Previous cervical conization or LEEP procedure or previous total hysterectomy due to cervical lesions at enrollment
13. High-grade intraepithelial lesions (CIN2/3) encompassing more than 180-degree (more than 2 quarters) of cervix
14. Positive HBV PCR if Hepatitis B surface antigen positive
15. Positive HCV PCR if anti-HCV positive
16. Border of high-grade intraepithelial lesions (CIN2/3) could not be completely observed by colposcope and positive for high grade disease by endocervical curettage.
17. Cervical biopsy and/or ECC of adenocarcinoma in situ (AIS)
18. Pre-biopsy Pap of Atypical Glandular Cells (AGC)/AGC favor neoplasm, squamous cell carcinoma (SCC), or cervical biopsy of CIN2/3 with postmenopausal bleeding

19. Participant has:

    1. Less than 2 acceptable potential injection sites for IM injection and electroporation considering the left and right medial deltoid, and anterolateral quadriceps muscles. A site for injection and electroporation is not acceptable if there is inadequate muscle mass to support at least a 19 mm/0.75 inch injection depth or a skinfold thickness measurement of ≥50 mm as assessed using the provided caliper. Eligible injection sites must also be free from tattoos, hypertrophic skin patches, keloids or other skin conditions which could interfere with the administration procedure or subsequent assessment of local reactogenicity.
    2. Note: To ensure adequate muscle mass for administrations, for participants with a weight ≤65 kg, potentially eligible administration sites are confined to the outer aspect of the upper thigh (left or right vastus lateralis muscle) (i.e., the left and right medial deltoid are not eligible administration sites).
20. Contraindication to intramsucular injections and blood draws.
21. A metal implant or implantable device within the area of the electroporation injection site at > 2 of the eligible injection sites.
22. A nonremovable electronic stimulation device, such as cardiac demand pacemakers, automatic implantable cardiac defibrillator, nerve stimulators, or deep brain stimulators.
23. Participant is an employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employees or the investigator.
24. Vulnerable participants (e.g., incarcerated individuals, individuals under a legal protection measure).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active; PVX4 (pBI-4 DNA vaccine administered via the Intramuscular TriGrid Electroporation Delivery System version 2.0)	Combination product: PVX4 Combination 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)
Placebo Comparator: Placebo; Sodium Chloride 0.9% for injection administered via the Intramuscular TriGrid Electroporation Delivery System version 2.0	Other: Placebo Control; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sustained virological clearance of HPV16	The proportion of subjects that exhibit HPV16 positivity by Roche Cobas test at Month 12.	Month 12
TDS-IM v2.0 Device Reliability	The proportion of administration procedures where a device fault is observed.	Week 0, 4, and 8

Collaborators and Investigators

• Sponsor: PapiVax Biotech, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: February 27, 2026
• First Submitted That Met QC Criteria: March 2, 2026
• First Posted (Actual): March 6, 2026

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: May 3, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: HPV16; Human papilloma virus; CIN 2/3; DNA vaccine; Cervical intraepithelial neoplasia; HSIL
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Uterine Diseases; Genital Diseases, Female; Precancerous Conditions; Uterine Cervical Diseases; Uterine Cervical Dysplasia
• Other Study ID Numbers: PVX4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes