Actively Recruiting
PVX4 for the Treatment of Human Papilloma Virus (HPV)16+ Cervical Dysplasia
Led by PapiVax Biotech, Inc. · Updated on 2026-05-06
138
Participants Needed
10
Research Sites
113 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
PVX4 for the Treatment of Human Papilloma Virus (HPV)16+ Cervical Dysplasia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female subjects aged 18 to 60 years with biopsy-confirmed high grade cervical intraepithelial neoplasia (CIN2/3) confirmed by central review
- HPV16 positive by Roche Cobas genotyping test; co-infections with other HPV types allowed
- HIV negative
- Able and willing to comply with study procedures and available for one-year follow-up
- Of childbearing potential and agree to remain sexually abstinent, use contraception, or have a sterile partner through 6 months
- Adequate organ function defined by specific blood counts and liver/kidney function parameters at enrollment
You will not qualify if you...
- Pregnant, breastfeeding, or attempting pregnancy within 6 months
- Immunodeficiency or treatment with immunosuppressive medications
- Received any blood product within 3 months prior to enrollment
- Received any licensed vaccine within 2 weeks prior (4 weeks for live vaccines)
- Participation in another investigational study within 30 days prior to consent
- History of seizures unless seizure-free for 5 years
- Cancer history within past 5 years except localized skin cancer
- Chemotherapy, radiation, biological cancer therapy, or investigational agents within 28 days prior to first dose
- Surgery within 28 days prior, excluding minor procedures
- Uncontrolled illnesses affecting compliance
- Active autoimmune diseases
- Previous cervical conization, LEEP procedure, or total hysterectomy due to cervical lesions
- High-grade lesions covering more than 180 degrees of cervix
- Positive HBV or HCV PCR if seropositive
- Incomplete lesion observation by colposcopy or positive high-grade disease by endocervical curettage
- Adenocarcinoma in situ or certain abnormal Pap or biopsy findings
- Less than two acceptable injection sites due to muscle mass or skin conditions
- Contraindication to intramuscular injections or blood draws
- Presence of metal implants or electronic stimulation devices at injection sites
- Employment or family relation to study investigators
- Vulnerable populations such as incarcerated individuals or those under legal protection measures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
Montefiore Medical Center
The Bronx, New York, United States, 10467
Not Yet Recruiting
2
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung, Taiwan, Taiwan, 83301
Not Yet Recruiting
3
China Medical University Hospital
Taichung, Taiwan, Taiwan, 40447
Not Yet Recruiting
4
Taichung Veterans General Hospital
Taichung, Taiwan, Taiwan, 40705
Not Yet Recruiting
5
National Cheng Kung University Hospital
Tainan, Taiwan, Taiwan, 70403
Not Yet Recruiting
6
National Taiwan University Hospital
Taipei, Taiwan, Taiwan, 100225
Not Yet Recruiting
7
MacKay Memorial Hospital
Taipei, Taiwan, Taiwan, 10449
Not Yet Recruiting
8
Taipei Medical University Hospital
Taipei, Taiwan, Taiwan, 11031
Not Yet Recruiting
9
Taipei Veterans General Hospital
Taipei, Taiwan, Taiwan, 11217
Not Yet Recruiting
10
Linkou Chang Gung Memorial Hospital
Taoyuan, Taiwan, Taiwan, 33305
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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