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

NCT02576561 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2017-10-25

No results posted yet for this study

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.

Conditions

  • Human Papillomavirus
  • High-Grade Squamous Intraepithelial Lesions

Interventions

BIOLOGICAL

TVGV-1

Antigen + Adjuvant

BIOLOGICAL

GPI-0100

Adjuvant Alone

BIOLOGICAL

Placebo

Placebo

Sponsors & Collaborators

  • Clinical Research Management, Inc.

    collaborator INDUSTRY

  • THEVAX Genetics Vaccine

    lead INDUSTRY

Principal Investigators

  • Frank L Douglas, PhD, MD · THEVAX Genetics Vaccine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2018-05-31
Completion
2018-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02576561 on ClinicalTrials.gov