About the Study
Indication: Cervical High-Grade Squamous Intraepithelial (CIN) Lesions (HSIL)
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 High-Grade Squamous Intraepithelial Lesions (HSIL)
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.
HPV is a common sexually transmitted disease. Recent data from the Centers for Disease Control (CDC) in the USA, estimate that approximately 79 million Americans are currently infected with HPV, and 14 million persons are newly infected each year in the US (as of March 2014). Roughly 90% of HPV infections are cleared by the person’s own immune system within 2 years and cause no harm. The most common symptoms or signs of HPV infection are genital warts (which are not harmful and don’t cause cancer) and cervical dysplasia.
However, constant HPV infection can lead to the following:
1. Dysplasia: This means there are changes in the lining cells of the cervix. This is the first earliest form of cell changes that can be observed. The cell changes are ‘pre-cancerous’, which means there is a greater likelihood of cancer occurring, if left untreated. These changes can be described as low grade or high grade.
2. Premalignant: This is the next stage of dysplasia, and the cells are poised, or ready, to become cancerous, but it hasn’t happened yet.
3. Malignant: Changes have caused cancer. Cervical cancer is always proceeded by high- grade cervical dysplasia.
Cervical intraepithelial neoplasia (CIN) is a general term for potentially precancerous cell changes on the cervix. It is grouped into 3 categories according to the degree of dysplasia; mild (CIN1), moderate (CIN2), and severe dysplasia (CIN3). The World Health Organization estimates that every year in the US one million new cases of HPV-related low-grade dysplasia (CIN1) occur, and 300,000 new cases of high-grade dysplasia (CIN2+) are diagnosed.
The current terms used for these types of cervical cell changes are High Squamous Intraepithelial Lesions (HSIL) for CIN2/3, and Low Squamous Intraepithelial Lesions (LSIL) for CIN1. The standard of care for people with persistent HSIL lesions is excisional (cutting; removal by surgery) or ablative (burning by laser) therapy. There have been confirmed findings that excisional treatment is associated with significantly increased risk of preterm birth. Researchers are looking for non-surgical ways to treat HSIL. One of those ways would be to develop a vaccine to treat high grade lesions. There are vaccines that work to prevent HPV infection, but are not likely to eliminate pre-existing HPV-associated lesions.
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