Cervical Intraepithelial Neoplasia 3
Conditions
Keywords
Phase 1 follow up, Cervical Intraepithelial Neoplasia, Adult, Safety, Efficacy
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.
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.
Interventions
BIOLOGICALGX-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.
Sponsors
Genexine, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The change of the immune response compared to that of the final visit in phase I study | 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
| Measure | Time frame | Description |
|---|---|---|
| The change of the involved lesion and HPV infection status | 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 |
| Safety profile | at week 0 to 180 every 6 months | Safety profile would be examined by vital signs, physical examination, clinical laboratory tests etc |
Countries
South Korea
Outcome results
None listed