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Phase 2 Clinical Trial to Evaluate the Safety and Efficacy of Plasmid DNA Therapeutic Vaccine(GX-188E)

NCT02596243 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 134

Last updated 2017-07-12

No results posted yet for this study

Summary

The purpose of this study is to access the efficacy and safety of GX-188E according the protocol in patients with Cervical Intraepithelial Neoplasia 2, 2/3 or 3 (CIN3)

Conditions

  • Cervical Intraepithelial Neoplasia

Interventions

BIOLOGICAL

GX-188E

1mg of GX-188E administered IM using EP device at day 0, week 4 and week 12.

BIOLOGICAL

Placebo

0.5mL of Placebo administered IM using EP device at day 0, week 4 and week 12.

Sponsors & Collaborators

  • Genexine, Inc.

    lead INDUSTRY

Principal Investigators

  • Terje Raud, MD · Tartu University Hospital

  • Kersti Kukk, MD · North Estonia Medical Centre Foundation

  • Aira Peri, MD · East Tallinn Central Hospital

  • Tetiana Tatarchuk, MD · National Academy of Medical Sciences of Ukraine

  • Nataliya Lutsenko, MD · State Institution, Zaporizhzhia Medical Academy of Post-Graduate Education Ministry of Health of Ukraine

  • Sergiy Kartashov, MD · Kharkiv medical academy of postgraduate education

  • Natalia Rozhkovska, MD · Multi-profile Medical Center (University Clinic No. 1) of Odesa National Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2018-03-31
Completion
2018-08-31

Countries

  • Estonia
  • South Korea
  • Ukraine

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 NCT02596243 on ClinicalTrials.gov