NCT02576561

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: THEVAX Genetics Vaccine · Industry
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Human Papillomavirus
• High-Grade Squamous Intraepithelial Lesions

Interventions

Type	Name	Description
BIOLOGICAL	TVGV-1	Antigen + Adjuvant
BIOLOGICAL	GPI-0100	Adjuvant Alone
BIOLOGICAL	Placebo	Placebo

Timeline

• Start date: 2015-11-01
• Primary completion: 2018-05-01
• Completion: 2018-09-01
• First posted: 2015-10-15
• Last updated: 2017-10-25

Locations

11 sites across 1 country: United States