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Safety and Efficacy of GX-188E DNA Therapeutic Vaccine Administered by Electroporation After Observation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02100085
Recruitment Status : Unknown
Verified July 2017 by Genexine, Inc..
Recruitment status was:  Active, not recruiting
First Posted : March 31, 2014
Last Update Posted : July 12, 2017
Sponsor:
Information provided by (Responsible Party):
Genexine, Inc.

Brief Summary:
This study is to follow up on the change of immune response by measuring HPV type 16/18 E6 and E7 specific T cell response and lesion condition in subjects who have administered in DNA-based therapeutic vaccine.

Condition or disease Intervention/treatment
Cervical Intraepithelial Neoplasia 3 Biological: GX-188E

Detailed Description:

This is a follow-up study to investigate the change of immunogenicity and lesion condition in subjects with cervical intraepithelial neoplasia (CIN) 3 who have enrolled and completed GX-188E phase I study.

Subjects will make visits at week 48 (V1) to week 228 (V8) every 6 months after the final administration of GX-188E.

The endpoints are to evaluate the change of immune response, involved lesion and infection status compared to that of the final visit in phase I study.

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Study Type : Observational
Actual Enrollment : 9 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Single Center, Phase I Study to Follow-up on the Change of Immunogenicity and Lesion Condition in Subjects Who Have Completed the Phase I GX-188E Trial (Protocol no. GX-188E-SN)
Actual Study Start Date : February 2014
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Observational group
Subjects in the period less than 48 weeks after the final administration of GX-188E
Biological: GX-188E
In phase I study, 9 patients were assigned to three dose groups (1mg, 2mg and 4mg) and were administered three times with GX-188E by electroporation during an entire period of study. After the final administration, the follow-up will be conducted to investigate safety and efficacy aspects.
Other Name: GX-188E administerd by eletrophoration




Primary Outcome Measures :
  1. The change of the immune response compared to that of the final visit in phase I study [ Time Frame: at week 0 to 180 every 6 months ]
    It would be determined by evaluating HPV type 16/18 E6 and E7 specific T cell response (IFN-γ ELISPOT assay) using PBMC obtained at week 0 to 180 visit every 6 months.


Secondary Outcome Measures :
  1. The change of the involved lesion and HPV infection status [ Time Frame: at week 0 to 180 every 6 months ]
    The changes of histological test, cytological test and HPV infection status would be compared to that of the last visit in phase I study

  2. Safety profile [ Time Frame: at week 0 to 180 every 6 months ]
    Safety profile would be examined by vital signs, physical examination, clinical laboratory tests etc


Biospecimen Retention:   Samples Without DNA
plasma and PBMC (peripheral blood mononeuclear cells)


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The subjects who have completed the DNA vaccine administration of each dosage (1, 2 and 4 mg).

The subjects in the period less than 48 weeks after the final administration of GX-188E

Criteria

Inclusion Criteria:

  • Female aged between 20 and 50 (inclusive)
  • The subjects who have visited within 48 weeks after final injection of GX-188E
  • Those who voluntarily signed informed consent form

Exclusion Criteria:

  • Prior participation in any clinical trial within 30 days prior to the visit 1
  • Any other ineligible condition at the discretion of the investigator that would be ineligible to participate the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02100085


Locations
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Korea, Republic of
Cheil General Hospital & Women's Healthcare Center
Seoul, Korea, Korea, Republic of
Sponsors and Collaborators
Genexine, Inc.
Investigators
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Principal Investigator: Tae Jin Kim, M.D. Cheil General Hospital & Women's Healthcare Center

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Responsible Party: Genexine, Inc.
ClinicalTrials.gov Identifier: NCT02100085    
Other Study ID Numbers: GX-188E-FU
First Posted: March 31, 2014    Key Record Dates
Last Update Posted: July 12, 2017
Last Verified: July 2017
Keywords provided by Genexine, Inc.:
Phase 1 follow up
Cervical Intraepithelial Neoplasia
Adult
Safety
Efficacy
Additional relevant MeSH terms:
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Cervical Intraepithelial Neoplasia
Neoplasms
Carcinoma in Situ
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type