PVX4 for the Treatment of Human Papilloma Virus (HPV)16+ Cervical Dysplasia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-60
SponsorPapiVax Biotech, Inc.
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- PVX4 Combination Product
- Placebo Control
Treatment groups
138 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov