Human Papillomavirus Clinical Trial
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
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.
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.
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