NCT03911076

Phase II Study of Treatment for HPV16+ ASC-US, ASC-H and LSIL

A Randomized Double-Blind, Placebo-controlled Phase II Trial With Safety Run-In of Intramuscular pNGVL4a-Sig/E7(Detox)/HSP70 and TA-CIN for the Treatment of Patients With HPV16+ Atypical Squamous Cells of Undetermined Significance (ASC-US) or Cannot Exclude High Grade SIL (ASC-H) Cytology or Low-grade Squamous Intraepithelial Lesion (LSIL)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: PapiVax Biotech, Inc. · Academic / Other
• Sex: Female
• Age: 25 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

* To evaluate the safety and tolerability of the dual IM pNGVL4a Sig/E7(detox)/HSP70 DNA and single IM TA-CIN immunization regimen * To evaluate the efficacy of dual IM pNGVL4a-Sig/E7(detox)/HSP70 DNA and single IM TA-CIN immunization regimen on Human Papillomavirus (HPV) 16 clearance by Month 6

Detailed description

Patients with human papillomavirus type 16 (HPV16) infection and low-grade cervical dysplasia \[low-grade squamous intraepithelial lesion (LSIL)/CIN1\] or atypical squamous cells \[atypical squamous cells of undetermined significance (ASC-US)/atypical squamous cells- cannot exclude high-grade squamous intraepithelial lesion (ASC-H)\] require active surveillance for disease progression. A safe and effective immunotherapy to clear HPV16 is an unmet medical need. This study (NCT03911076) is a randomized double-blind, placebo-controlled phase II trial of PVX2 \[vaccination twice with HPV16-targeting pNGVL4a-Sig/E7(detox)/HSP70 plasmid and once with the HPV16 L2E7E6 fusion protein "TA-CIN"\] as immunotherapy for patients with HPV16+ ASC-US, ASC-H, or LSIL/CIN1. The primary objective of this cohort is to determine the safety and tolerability of PVX2 in three monthly immunizations. Subjects are confirmed to have HPV16 infection and LSIL/CIN1, ASC-US, or ASC-H. Adverse events are evaluated using Common Terminology Criteria for Adverse Events v5.0. HPV typing by HPV16 18/45 Aptima Assay is performed at baseline, month 6, and month 12, with simultaneous cytology analysis. Cervical biopsies and endocervical curettage are performed at baseline and month 6. In a safety run-in cohort 12 eligible patients are enrolled prior to the randomized phase.

Conditions

• ASC-US
• ASC-H
• LSIL

Interventions

Type	Name	Description
BIOLOGICAL	PVX-2	pNGVL4a-Sig/E7(detox)/HSP70 (pBI-1, naked DNA plasmid priming vaccine) TA-CIN (HPV16 L2E7E6 fusion protein booster vaccine)
OTHER	Placebo	PBS and PGC

Timeline

• Start date: 2019-05-22
• Primary completion: 2022-06-08
• Completion: 2022-06-08
• First posted: 2019-04-10
• Last updated: 2024-06-17

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study