Phase II Study of Treatment for HPV16+ ASC-US, ASC-H and LSIL — PVX-2

ASC-US Clinical Trial

Official title:
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 Recruiting

Clinical Trial 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

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

ASC-H Atypical Squamous Cells, Cannot Rule Out High-Grade Squamous Intra-Epithelial Lesion
ASC-US
LSIL

Clinical Trial Details

NCT number	NCT03911076
Study type	Interventional
Source	PapiVax Biotech, Inc.
Contact	Muchou J Ma, MD
Phone	+1 407 971 1487
Email	joe@papivax.com.tw
Status	Recruiting
Phase	Phase 2
Start date	May 22, 2019
Completion date	January 30, 2024

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT03409471` - HPV Test of Urine and Self Collected Vaginal Samples for Cervical Cancer Screening Study
Completed	`NCT03903952` - Can B12 and Folate Levels Predict HPV Penetration in Patients With ASCUS?	N/A
Recruiting	`NCT05808816` - "Lactobacillus Crispatus M247, LSIL and Microbiota"	Phase 4
Recruiting	`NCT03913117` - Study of Treatment for HPV16+ ASC-US or LSIL	Phase 1
Completed	`NCT03372395` - Probiotic Implementation as Help in Solving Vaginal Infections	Phase 2