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NCT07454915
PVX4 for the Treatment of Human Papilloma Virus (HPV)16+ Cervical Dysplasia
Phase 2 trial testing PVX4 Combination Product in Cervical Intraepithelial Neoplasia Grade 2/3 in 138 participants. Currently enrolling.
1 December 2027
Quick facts
| Lead sponsor | PapiVax Biotech, Inc. |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 138 |
| Start date | 1 April 2026 |
| Primary completion | 1 December 2027 |
| Estimated completion | 1 June 2028 |
| Sites | 10 locations across United States, Taiwan |
Drugs / interventions tested
- PVX4 Combination Product
- Placebo Control
Conditions studied
- Cervical Intraepithelial Neoplasia Grade 2/3 — all drugs for Cervical Intraepithelial Neoplasia Grade 2/3 →
- Human Papilloma Virus Infection Type 16 — all drugs for Human Papilloma Virus Infection Type 16 →
Sponsor
PapiVax Biotech, Inc. — full company profile →
Who can join
Adults 18 to 60, female only, with Cervical Intraepithelial Neoplasia Grade 2/3 or Human Papilloma Virus Infection Type 16. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Proportion of subjects exhibiting virological clearance of HPV16 and histopathological regression of cervical lesions to < CIN2 at Month 6
Time frame: 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.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07454915
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Cervical Intraepithelial Neoplasia Grade 2/3
Currently open trials in the same condition.
- NCT03064087 — Validation of Human Papillomavirus Assays and Collection Devices for Self-samples and Urine Samples · active not recruiting
Other PapiVax Biotech, Inc. trials
Trials by the same sponsor.
- NCT03911076 — Phase II Study of Treatment for HPV16+ ASC-US, ASC-H and LSIL · Phase 2 · terminated
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07454915 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by PapiVax Biotech, Inc.
- Last refreshed: 3 May 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07454915.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing