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

NCT02100085 | Unknown

• 1 other identifier: GX-188E-FU
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Intraepithelial Neoplasia 3

Keywords

Phase 1 follow up; Cervical Intraepithelial Neoplasia; Adult; Safety; Efficacy

Outcome Measures

Primary Outcomes (1)

• The change of the immune response compared to that of the final visit in phase I study

  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.

  at week 0 to 180 every 6 months

Secondary Outcomes (2)

• The change of the involved lesion and HPV infection status

  at week 0 to 180 every 6 months

• Safety profile

  at week 0 to 180 every 6 months

Study Arms (1)

Observational group

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

Biological: GX-188E

Interventions

GX-188E BIOLOGICAL

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.

Also known as: GX-188E administerd by eletrophoration

Observational group

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Genexine, Inc.: lead

Study Sites (1)

Cheil General Hospital & Women's Healthcare Center

Seoul, Korea, South Korea

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma and PBMC (peripheral blood mononeuclear cells)

MeSH Terms

Conditions

Uterine Cervical Dysplasia

Interventions

GX-188 vaccine

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Tae Jin Kim, M.D.

  Cheil General Hospital & Women's Healthcare Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2014
• First Posted: March 31, 2014
• Study Start: February 1, 2014
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: July 12, 2017

Record last verified: 2017-07

Locations

KR (1)