Clinical Trial: Dose-finding, Safety Study of Plasmid DNA Therapeutic Vaccine to Treat Cervical Intraepithelial Neoplasia

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: A Randomized, Open-label, Multi-center, Phase 2 Clinical Trial to Determine the Optimal Dose and Evaluate the Safety of GX-188E, a DNA-based Therapeutic Vaccine, Administered Intramuscularly by Electr

Brief Summary: The purpose of this study is to determine the optimal dose of GX-188E for the Phase 3 and access the efficacy and safety of GX-188E according the protocol in patients with Cervical Intraepithelial Neoplasia 3 (CIN3).

Detailed Summary: Subjects who are eligible for this study are allocated to one of the two treatment groups of GX-188E. All Subject received GX-188E intramuscularly using the electroporator(EP) on alternating deltoid muscles which will be performed totally three times during the study period.
Sponsor: Genexine, Inc.

Current Primary Outcome: The Rate of Participants with Histopathological Regression of Cervical Lesions to CIN1 or Less [ Time Frame: 20 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • The Rate of Participants Whose Result Inverted Negative in HPV DNA test [ Time Frame: 20 weeks ]
  • The rate of HPV E6, E7-specific ELISPOT responder defined in the protocol [ Time Frame: 20 weeks ]
  • Cytological Changes of the Cervical Lesions [ Time Frame: 20 weeks ]
  • The Rate of Adverse Events and the Related Features after Administration of Investigational Product [ Time Frame: 20 weeks ]
  • The Rate of Solicited Adverse Events and the Related Features [ Time Frame: 20 weeks ]
  • Data in Physical examination, Vital signs, Electrocardiography, Clinical Laboratory Test Results Related to Investigational Product [ Time Frame: 20 weeks ]
  • Mean Value of Visual Analogue Scale on Pain Intensity [ Time Frame: 20 weeks ]
  • Flt-3L Serum Concentration [ Time Frame: 20 weeks ]


Original Secondary Outcome: Same as current

Information By: Genexine, Inc.

Dates:
Date Received: May 13, 2014
Date Started: May 2014
Date Completion: October 2016
Last Updated: May 13, 2016
Last Verified: May 2016