Spots Global Cancer Trial Database for Safety and Efficacy Study of TVGV-1 Vaccine to Treat HPV Induced Cervical HSIL

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Trial Identification

Brief Title: Safety and Efficacy Study of TVGV-1 Vaccine to Treat HPV Induced Cervical HSIL

Official Title: Phase 2a Double-Blind, Randomized, Parallel Group, Dose-Ranging Study to Assess the Safety and Efficacy of Three Doses of TVGV-1 Vaccine Compared to Its Adjuvant, GPI-0100, in Subjects With Histologically Confirmed HPV Induced Cervical HSIL

Study ID: NCT02576561

Conditions

Human Papillomavirus

High-Grade Squamous Intraepithelial Lesions

Interventions

TVGV-1

GPI-0100

Placebo

Study Description

Brief Summary: The purpose of this research study is to test the safety and effectiveness of the investigational study vaccine, called TVGV-1. The study will test the vaccine in women with high grade HPV cervical infection.

Detailed Description: The purpose of the Phase 2a Study VAX 02-01 is to assess the safety and activity of TVGV-1 vaccine construct in achieving the absence of histologic HSIL (CIN2/3) (regression to LSIL or less) as assessed by biopsy at last study Visit 11, Day 270. The objective of the TVGV-1 program is to develop a non-surgical alternative that is reliable, safe, and would avoid potential surgical risks such as preterm birth, perinatal mortality, risk of infertility, incontinence and disfigurement, as well as reduced cost and inconvenience for an otherwise economically productive young subject population.