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

ConditionsCervical Intraepithelial Neoplasia Grade 2/3Human Papilloma Virus Infection Type 16
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • PVX4 Combination Product

    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)

  • Placebo Control

    Other intervention

    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)

Treatment groups

138 Participants
are divided into 2 treatment groups
Group A: ActiveExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame
Month 6

Secondary outcomes

1

Sustained virological clearance of HPV16

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

Time frame
Month 12
2

TDS-IM v2.0 Device Reliability

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

Time frame
Week 0, 4, and 8

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

PapiVax Biotech, Inc.

Lead sponsor

Source ClinicalTrials.gov
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