Clinical Trial: Safety of GX-188E DNA Therapeutic Vaccine Administered by Electroporation to Cervical Intraepithelial Neoplasia Grade 3

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Single Center, Open-label, Dose-escalating, Phase Ι Study to Evaluate the Safety of GX-188E Administered by Electroporation (EP) in DNA-based Therapeutic Vaccine for Patients With This study is an open-label, dose-escalation, single-center, phase I study to evaluate the safety of GX-188E, a DNA-based therapeutic vaccine, administered by electroporation (EP) in patients with HPV-16 or HPV-18 associated cervical intraepithelial neoplasia grade 3 (CIN 3).

Each subject eligible to participate in the trial is given a subject number, which is assigned sequentially in ascending order, then allocated to only a single dose level of the drug. Three subjects are allocated at each dose level starting with 1mg whereby the dose is escalated in sequential subjects in ascending numerical order of subject ID.

Each subject visit the site three times for administration during the study and is given an intramuscular injection of GX-188E at a dose of 1mg, 2mg or 4mg by electroporation at each visit

The subjects conduct the follow-up visits twice, which are 8 weeks and 24 weeks after the third injection of GX-188E respectively.


Sponsor: Genexine, Inc.

Current Primary Outcome: Determination of maximum MTD by defining the safety profile of GX-188E [ Time Frame: From baseline to end of study ]

It would be determined based on the rate and severity grade of events or abnormalities through evaluating systemic or local adverse events, clinical laboratory test results, vital signs and so on.


Original Primary Outcome: The maximum tolerated dosage and safety profile of GX-188 administered by Electroporation [ Time Frame: One year ]

This will be determined by the 3+3 design.


Current Secondary Outcome:

  • The expression levels of GX-188E in blood [ Time Frame: At week -2, week 2, week 12 ,week 20 and week 36 ]
  • Immunologic reactogenicity by measuring HPV E6 and E7 specific T cell response (IFN-γ ELISPOT) [ Time Frame: At week -2, week 2, week 12 ,week 20 and week 36 ]
  • The changes of the involved lesions and HPV infection status [ Time Frame: Baseline, week 12 ,week 20 and week 36 ]


Original Secondary Outcome:

  • The amount of the expressed antigen of GX-188 in patients' blood [ Time Frame: One year ]
  • Immune Response specific for E6 or E7 Antigen of HPV by IFN-γ ELISPOT assay [ Time Frame: One year ]


Information By: Genexine, Inc.

Dates:
Date Received: July 3, 2012
Date Started: November 2012
Date Completion:
Last Updated: February 14, 2014
Last Verified: February 2014