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Cervical Intraepithelial Neoplasia Grade 2/3Phase 2NCT07454915

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

A Phase 2 study testing PVX4 Combination Product in people with Cervical Intraepithelial Neoplasia Grade 2/3 and Human Papilloma Virus Infection Type 16, run by PapiVax Biotech, Inc. at 10 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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 TriGrid™ Delivery System) in patients with biopsy-confirmed, human papilloma virus (HPV) 16-associated high grade… Read more about this study

Who is it for?
Ages 18 to 60 years, women only
What is being tested?
PVX4 Combination Product
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
138 participants
Where
10 sitesin 2 countries
Study dates
1 Apr 2026to Jun 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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)
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  • 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
  • Border of high-grade intraepithelial lesions (CIN2/3) could not be completely observed by colposcope and positive for high grade disease by endocervical curettage.
  • Cervical biopsy and/or ECC of adenocarcinoma in situ (AIS)
  • Pre-biopsy Pap of Atypical Glandular Cells (AGC)/AGC favor neoplasm, squamous cell carcinoma (SCC), or cervical biopsy of CIN2/3 with postmenopausal bleeding
  • Participant has:
  • 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.
  • 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).
  • Contraindication to intramsucular injections and blood draws.
  • A metal implant or implantable device within the area of the electroporation injection site at > 2 of the eligible injection sites.
  • A nonremovable electronic stimulation device, such as cardiac demand pacemakers, automatic implantable cardiac defibrillator, nerve stimulators, or deep brain stimulators.
  • 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.
  • Vulnerable participants (e.g., incarcerated individuals, individuals under a legal protection measure).

Trial locations and contacts

10 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

10 sites in 2 countries

Taiwan9 sites, 9 recruiting

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung, Taiwan, 83301

    Chen-Hsuan Wu, MD

    Not yet recruiting

  • China Medical University Hospital

    Taichung, Taiwan, 40447

    Lian-Shung Yeh, MD

    Not yet recruiting

  • Taichung Veterans General Hospital

    Taichung, Taiwan, 40705

    Shih-Tien Hsu, MD

    Not yet recruiting

  • National Cheng Kung University Hospital

    Tainan, Taiwan, 70403

    Pei-Ying Wu, MD

    Not yet recruiting

  • National Taiwan University Hospital

    Taipei, Taiwan, 100225

    Yu-Li Chen, MD

    Not yet recruiting

  • MacKay Memorial Hospital

    Taipei, Taiwan, 10449

    Chih-Long Chang, MD

    Not yet recruiting

  • Taipei Medical University Hospital

    Taipei, Taiwan, 11031

    Jiantai Timothy Qiu, MD

    Not yet recruiting

  • Taipei Veterans General Hospital

    Taipei, Taiwan, 11217

    Yi-Jen Chen, MD

    Not yet recruiting

  • Linkou Chang Gung Memorial Hospital

    Taoyuan, Taiwan, 33305

    Clinical Trial Office, +886 3 3281200 ext. 8254, ray557722@gmail.com

    Chyong-Huey Lai, MD

    Recruiting

Other trials in Taiwan

United States1 site, 1 recruiting

  • Montefiore Medical Center

    The Bronx, New York, 10467

    Juan D Quniones, MD

    Not yet recruiting

Other trials in United States

About this study

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.

Being tested
PVX4 Combination Product, Placebo Control
Keywords
Human papilloma virus, HPV16, HSIL, CIN 2/3, DNA vaccine, Cervical intraepithelial neoplasia
Medical subject headings
Uterine Cervical Dysplasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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)

  • 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)

Study groups in NCT07454915
Study groupRoleWhat they receive
ActiveExperimentalPVX4 (pBI-4 DNA vaccine administered via the Intramuscular TriGrid Electroporation Delivery System version 2.0)
Receives: Combination Product: PVX4 Combination Product
PlaceboPlacebo comparatorSodium Chloride 0.9% for injection administered via the Intramuscular TriGrid Electroporation Delivery System version 2.0
Receives: Other: Placebo Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Month 6

Secondary outcomes (2)

  1. Sustained virological clearance of HPV16

    The proportion of subjects that exhibit HPV16 positivity by Roche Cobas test at Month 12.

    Measured: Month 12

  2. TDS-IM v2.0 Device Reliability

    The proportion of administration procedures where a device fault is observed.

    Measured: Week 0, 4, and 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2026
  2. Study start1 Apr 2026
  3. Primary completionDec 2027 (estimated)
  4. Study completionJun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
138 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07454915
Sponsor's protocol ID
PVX4
Status last verified
Apr 2026
First submitted
27 Feb 2026
Last updated
6 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes
Individual data sharing
No: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PVX4 Combination Product in people with Cervical Intraepithelial Neoplasia Grade 2/3 and Human Papilloma Virus Infection Type 16, run by PapiVax Biotech, Inc. at 10 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Taiwan, United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of subjects exhibiting virological clearance of HPV16 and histopathological regression of cervical lesions to < CIN2 at Month 6 (time frame: Month 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07454915.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.

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