Infections

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Respiratory Tract Infections

Squamous Intraepithelial Lesions of the Cervix

Carcinoma

Carcinoma, Squamous Cell

Carcinoma in Situ

Uterine Cervical Dysplasia

Precancerous Conditions

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Cervical Intraepithelial Neoplasia

All Drugs and Chemicals

Vaccines

Antigen + Adjuvant - 0.6 mg lyophilized PEK fusion protein + 0.6 ml\* GPI- 0100 (1:1 ratio)

Adjuvant Alone - 0 mg lyophilized PEK fusion protein. 0.6 mg lyophilized placebo cake + 0.6 ml\* GPI- 0100 (1:1 ratio)

Placebo- 0 mg lyophilized PEK fusion protein. 0.6 mg lyophilized placebo cake + 0.6 ml placebo-diluent (1:1 ratio)

Antigen + Adjuvant - 0.9 mg lyophilized PEK fusion protein + 0.9 ml\* GPI- 0100 (1:1 ratio)

Adjuvant Alone - 0 mg lyophilized PEK fusion protein. 0.9 mg lyophilized placebo cake + 0.9 ml\* GPI- 0100 (1:1 ratio)

Placebo - 0 mg lyophilized PEK fusion protein. 0.9 mg lyophilized placebo cake + 0.9 ml placebo diluent (1:1 ratio)

Antigen + Adjuvant - 1.2 mg lyophilized PEK fusion protein + 1.2 ml\* GPI- 0100 (1:1 ratio)

Adjuvant Alone - 0 mg lyophilized PEK fusion protein + 1.2 mg lyophilized placebo cake 1.2 ml\* GPI- 0100 (1:1 ratio)

Placebo - 0 mg lyophilized PEK fusion protein. 1.2 mg lyophilized placebo cake + 1.2 ml placebo-diluent (1:1 ratio)

TVGV-1

GPI-0100

Placebo

Frank L Douglas, PhD, MD

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.

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

The primary analysis for efficacy will be a comparison between subjects treated with and without the PEK fusion protein with respect to the percentage who present regression of HSIL at Day 270. Separate comparisons within each cohort will be performed using Fisher's exact test (or an appropriate analogue). No adjustment for multiple comparisons will be employed in these analyses. Additionally, a corresponding comparison across all study subjects combined will be performed, based on Cochran-Matel-Haenszel test stratified for cohort.

Summaries of the data pertaining to the primary safety outcome of skin toxicity will be provided. Summaries will be provided for the within-cohort subsets of subjects treated with the active, and with the adjuvant alone; and the combined subsets across all three cohorts of subject treated with the active, with the adjuvant alone, and with the placebo. Serious adverse events will be described in narrative with the participant's demographics, treatment date, event, onset date, relationship to the study treatment and the descriptions of the actions and outcomes during this event. Any deaths occurring in the study will be summarized in narrative with the demographics, treatment duration, cause of death, date of death and additional information surrounding that serious adverse event.

Appropriate laboratory data will be transformed prior to analysis as defined in the Statistical Analysis Plan (SAP). Summaries will be presented for each evaluation time point, as well as for changes from baseline. Changes from baseline will also be presented using shift tables for selected laboratory parameters.

Clinical Research Management, Inc.

THEVAX Genetics Vaccine

Uterine Cervical Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Central Nervous System Depressants

Coagulants

Anesthetics

Hemostatics

In the research arm patients who underwent cold-knife conization of the cervix underwent hemostatic sutures laterally to the cervix, at localization of 3 and 9 hours with 2-0 vicryl thread. These sutures were held prior to the onset of cold conization of the cervix.

Cold Knife Conization with stitches

In the research arm patients who underwent cold-knife conization of the cervix have not undergone hemostatic sutures laterally to the cervix, at localization of 3 and 9 hours with 2-0 vicryl thread. After patient anesthesia and routine antisepsis was performed, cold knife conization of the cervix was performed.

Cold knife Conization without stitches

Ricardo D Reis, MD

The treatment of high grade Cervical Intraepithelial Neoplasia (CIN) 2, 3 is defined according to the colposcopic evaluation of the patient. In case colposcopy findings are satisfactory (visible squamocolumnar junction), both ablative and excisional methods are adequate. In the middle of the 20th century, lateral hemostatic sutures were added to the cold knife conization surgical technique to reduce blood loss. Some authors recommend that these branches should be ligated, but it remains unclear whether these sutures are actually effective in reducing bleeding.This study compared blood loss during cold knife conization of the cervix with and without lateral hemostatic sutures.

This is a study that will evaluate two groups of patients undergoing cold-knife conization for cervical intraepithelial neoplasia high grade where 50% will undergo hemostatic sutures in the lateral cervical and 50% of patients will not be subjected to these sutures. The main objective of the study is to evaluate the amount of intraoperative bleeding.

Cold Knife Conization With and Without Lateral Hemostatic Sutures

Randomized Clinical Trial Comparing Cold Knife Conization of the Cervix With and Without Lateral Hemostatic Sutures

The intraoperatory bleeding will be measure by weigh the gauze in grams (g).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Safety and Efficacy Study of TVGV-1 Vaccine to Treat HPV Induced Cervical HSIL	NCT02576561	Human Papilloma... High-Grade Squa...	TVGV-1 GPI-0100 Placebo	18 Years - 55 Years	THEVAX Genetics Vaccine
Safety and Efficacy Study of TVGV-1 Vaccine to Treat HPV Induced Cervical HSIL	NCT02576561	Human Papilloma... High-Grade Squa...	TVGV-1 GPI-0100 Placebo	18 Years - 55 Years	THEVAX Genetics Vaccine
Cold Knife Conization With and Without Lateral Hemostatic Sutures	NCT02184975	Cervical Intrae... Cervix Neoplasm...	Cold Knife Coni... Cold knife Coni...	15 Years - 80 Years	Barretos Cancer Hospital

Spots Global Cancer Trial Database for cold knife conization