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

Conditions

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

Eligibility Criteria

Sex

FEMALE

Age

18 Years - 60 Years

Healthy Volunteers

Not accepted

Interventions

• 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
  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)

Study Details

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.

Key Dates

Start date

Apr 1, 2026

Status verified

Apr 2026

Primary completion

Dec 31, 2027

Completion

Jun 30, 2028

Study Design

Enrollment

138 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Active
  PVX4 (pBI-4 DNA vaccine administered via the Intramuscular TriGrid Electroporation Delivery System version 2.0)
• Placebo Comparator: Placebo
  Sodium Chloride 0.9% for injection administered via the Intramuscular TriGrid Electroporation Delivery System version 2.0

Primary Outcome Measure

Proportion of subjects exhibiting virological clearance of HPV16 and histopathological regression of cervical lesions to < CIN2 at Month 6 [ Time Frame: Month 6 ]

Locations (1)

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