PVX4 for the Treatment of Human Papilloma Virus (HPV)16+ Cervical Dysplasia
PapiVax Biotech, Inc.
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.
Eligibility
- Age range
- 18–60 years
- Sex
- Female
- Healthy volunteers
- No
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 (…
Interventions
- Combination ProductPVX4 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)
- OtherPlacebo 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)
Locations (10)
- Montefiore Medical CenterThe Bronx, New York
- Kaohsiung Chang Gung Memorial HospitalKaohsiung, Taiwan
- China Medical University HospitalTaichung, Taiwan
- Taichung Veterans General HospitalTaichung, Taiwan
- National Cheng Kung University HospitalTainan, Taiwan
- National Taiwan University HospitalTaipei, Taiwan