PVX4 for the Treatment of Human Papilloma Virus (HPV)16+ Cervical Dysplasia (NCT07454915) | Clinical Trial Compass
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 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.
Who can participate
Age range18 Years – 60 Years
SexFEMALE
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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.
Exclusion criteria
✕. 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.
What they're measuring
1
Proportion of subjects exhibiting virological clearance of HPV16 and histopathological regression of cervical lesions to < CIN2 at Month 6
. 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.