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Clinical Trials List

Protocol NumberPVX4
NCT Number(ClinicalTrials.gov Identfier)NCT07454915
Active

2025-07-01 - 2029-06-30

Phase II

Recruiting9

ICD-10D06.0

Carcinoma in situ of endocervix

ICD-10D06.1

Carcinoma in situ of exocervix

ICD-10D06.7

Carcinoma in situ of other parts of cervix

ICD-10D06.9

Carcinoma in situ of cervix, unspecified

ICD-9233.1

Carcinoma in situ of cervix uteri

Clinical trial of PVX4 for the treatment of HPV16-positive cervical intraepithelial neoplasia

  • Trial Applicant

    Linical

  • Sponsor

    Linical Taiwan Co., Ltd.

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/07/24

Investigators and Locations

Principal Investigator 張志隆 Division of Obstetrics & Gynecology
MacKay Memorial Hospital

Co-Principal Investigator

  • 王有利 Division of Obstetrics & Gynecology
  • 陳楨瑞 Division of Obstetrics & Gynecology

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator
Taichung Veterans General Hospital

Co-Principal Investigator

  • 陳彥甫 Division of Obstetrics & Gynecology
  • Chien-Hsing Lu Division of Obstetrics & Gynecology
  • 孫珞 Division of Obstetrics & Gynecology
  • 黃曉峰 Division of Obstetrics & Gynecology
  • 石宇翔 Division of Obstetrics & Gynecology
  • 劉芝谷 Division of Obstetrics & Gynecology
  • 呂亭芳 Division of Obstetrics & Gynecology
  • 范鈞婷 Division of Obstetrics & Gynecology

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator
Taipei Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator
National Taiwan University Hospital

Co-Principal Investigator

  • 吳佳穎 Division of Obstetrics & Gynecology
  • 陳啓豪 Division of Obstetrics & Gynecology

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chyong-Huey Lai
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Human papillomavirus type 16 (HPV) type 16 (HPV type 16) cervical precancerous lesions (HPV type 16, HPV type 16, HPV type 2, HPV type 3, HPV type 3)

Objectives

The study evaluated the safety and efficacy of administering the pBI-4 vaccine via the TriGrid™ electroporation delivery system for the treatment of HPV16 infection and related precancerous cervical lesions.

Test Drug

PVX4

Active Ingredient

pBI-4 plasmid DNA

Dosage Form

liquid

Dosage

1.0mg/ 1.0 mL, 1.0 mL/vial

Endpoints

At month 6, the PVX4 treatment group and the placebo group showed pathological regression to below CIN1 and negative HPV16 results using Roche Cobas testing.

Inclution Criteria

Inclusion Criteria: You must meet all inclusion criteria to be included in the trial.

1. You must be a woman aged 18 to 60 years with a centrally reviewed cervical intraepithelial neoplasia (CIN2/3) on a cervical brush test.

2. Your cervical brush sample must be positive for HPV16 using Roche's Cobas HPV genotyping kit. If you are also infected with other HPV types, you may still be included in the trial.

3. Your HIV test result must be negative.

4. You must be able and willing to adhere to all trial procedures and expect to continue participating throughout the one-year follow-up period.

5. If you are of childbearing age, you must agree to abstain from sex or use effective contraception (e.g., oral contraceptives, barrier methods, spermicides, intrauterine devices) for six months from your first trial visit, or your partner must have undergone sterilization (vasectomy).

(6) You must meet the appropriate organ function criteria during the screening phase, including:

• White blood cell count > 3,000/mcL

• Lymphocyte count > 500/mcL

• Absolute neutrophil count > 1,000/mcL

• Platelet count > 90,000/mcL

• Heme > 9 g/dL

• Total bilirubin < 3 times the upper limit of normal (ULN)

• Aspartate aminotransferase (AST) < 3 times the upper limit of normal (ULN)

• Alanine aminotransferase (ALT) < 3 times the upper limit of normal (ULN)

• Creatinine < 2.5 times the upper limit of normal (ULN)

Exclusion Criteria

Exclusion Criteria: You will not be eligible to participate in this trial if you meet any of the following conditions:
1. You plan to become pregnant within 6 months, are currently pregnant, or are breastfeeding.

2. You have immunodeficiency or are currently receiving immunosuppressant therapy.

3. You have received blood product therapy within 3 months prior to enrollment in the trial.

4. You received any approved vaccine within 2 weeks prior to enrollment in the trial (4 weeks for live vaccines).

5. You participated in other clinical trials of investigational drugs or medical devices within 30 days prior to signing the informed consent form.

6. You have a history of epilepsy (you may be included if you have not had seizures in the past 5 years).

7. You have a history of cancer within the past 5 years (excluding localized skin cancer).

8. You received chemotherapy, radiation therapy, biologic cancer therapy, or other investigational drugs within 28 days prior to receiving the first dose of the investigational drug.

9. You underwent surgery, excluding minor procedures such as dental procedures or skin biopsies, within 28 days prior to receiving the first dose of the investigational drug.

10. You have uncontrollable comorbidities, including but not limited to persistent or active infections, symptomatic congestive heart failure, unstable angina, arrhythmia, mental illness, or social factors that may limit (affect) your compliance with trial requirements.

11. You have active autoimmune diseases (such as rheumatoid arthritis, lupus erythematosus, ulcerative colitis, Crohn's disease, multiple sclerosis, ankylosing spondylitis, etc.).

12. You underwent cervical conization or loop electrosurgical excision procedure (LEEP) prior to enrollment in the trial, or underwent a total hysterectomy due to cervical lesions.

13. You have high-grade intraepithelial neoplasia (CIN2/3) with lesions extending beyond 180 degrees of the cervix (more than half of the cervix).

14. You are positive for hepatitis B surface antigen (HBsAg) and have a positive hepatitis B virus polymerase chain reaction (HBV PCR) test.

15. You are positive for Hepatitis C virus (HCV) antibodies and have a positive HCV polymerase chain reaction (HCV PCR) test.

16. The boundaries of your CIN2/3 lesion could not be fully observed during colposcopy, and your cervical endometrial scraping showed high-grade lesions.

17. Your cervical biopsy or cervical endometrial scraping showed adenocarcinoma in situ (AIS).

18. Prior to biopsy, your cervical biopsy showed atypical glandular cells (AGC)/AGC leaning towards a tumor, squamous cell carcinoma (SCC), or your cervical biopsy showed CIN2/3 with postmenopausal bleeding.

19. You meet any of the following criteria:

a. You have fewer than two potential injection sites in the left and right medial deltoid muscles and the vastus lateralis muscles that can be used for intramuscular injection and electroporation. If the muscle thickness at the injection site is insufficient to support an injection depth of at least 19 mm, or if the subcutaneous fat thickness measured using designated calipers is ≥ 50 mm, the site is considered unsuitable for injection. Furthermore, the injection site must be free of tattoos, hypertrophic skin patches, keloids, or other skin conditions that may interfere with injection or subsequent assessment of local reactions.

b. Note: To ensure sufficient muscle mass, if the subject's weight is ≤ 65 kg, potentially acceptable injection sites are limited to the bilateral lateral thighs (left or right vastus lateralis), i.e., the deltoid muscles of both arms do not meet the criteria for acceptable injection sites.

20. You have contraindications to intramuscular injection or blood draw.

21. You have metal implants or implanted devices in more than two available injection sites.

22. You have an inescapable electronic stimulation device, such as a pacemaker, implantable defibrillator, autonomic stimulator, or deep brain stimulator.

23. You are a trial principal investigator or staff member of the trial center, and are directly involved in this trial or other trials conducted under the principal investigator's guidance, or a family member of that staff member or principal investigator.

24. Vulnerable groups (such as incarcerated persons or those under statutory protection).

The Estimated Number of Participants

  • Taiwan

    128 participants

  • Global

    138 participants

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