RecruitingPhase 2

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

United States, Taiwan138 participantsStarted 2026-04-01

Plain-language 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 cervical intraepithelial neoplasia (CIN2/3) as compared to the administration of placebo.

Who can participate

Age range

18 Years – 60 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Month 6

Trial details

NCT IDNCT07454915

SponsorPapiVax Biotech, Inc.

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12

View on ClinicalTrials.gov More Cervical Intraepithelial Neoplasia Grade 2/3 trials

Plain-language summary

Who can participate

Age range

18 Years – 60 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria