Cervical Intraepithelial Neoplasia 3GX-188ENCT02411019
Safety and Efficacy of GX-188E DNA Therapeutic Vaccine Administered by Electroporation After Observation
An observational study of Cervical Intraepithelial Neoplasia 3, run by Genexine, Inc. at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 50 years, women only
- Conditions the study is for
- Cervical Intraepithelial Neoplasia 3
- What is being tested?
- GX-188E
- How many people
- 67 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2015to Nov 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: The subjects who have completed the DNA vaccine administration of each dosage (1 and 4 mg).
Who may be able to join
- Those who voluntarily signed informed consent form
- The subjects who have participated in phase II trial(GX-188E_CIN3_P2)
Who cannot join
- The subjects who didn't receive GX-188E DNA vaccine during Phase II trial (GX-188E_CIN3_P2)
- The subjects, it is difficult to participate in this study continuously
- Any other ineligible condition at the discretion of the investigator that would be ineligible to participate the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Observational, Open-label, Multi-center, Follow-up Clinical Study to Determine Recurrence of Cervical Intraepithelial Neoplasia and Evaluate the Long-term Safety of GX-188E, a DNA-based Therapeutic Vaccine, Administered Intramuscularly by Electroporation (EP) in Subjects Who Were Diagnosed With HPV(Human Papillomavirus) 16 or 18 Positive Cervical Intraepithelial Neoplasia 3 (CIN 3) and Participated in Phase 2 Trial (GX-188E_CIN3_P2)
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.
Read the 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 participated GX-188E phase II trial(GX-188E_CIN3_P2).
Subjects will make visits 7 times for about three years from the last visit of GX-188E phase 2 trial (GX-188E_CIN3_P2).
The endpoints are to evaluate the change of immune response, involved lesion and infection status compared to that of the final visit in phase 2 trial (GX-188E_CIN3_P2).
- Conditions
- Cervical Intraepithelial Neoplasia 3
- Being tested
- GX-188E
- Keywords
- Phase 2 follow up, Cervical Intraepithelial Neoplasia, Adult, Safety, Efficacy
- Medical subject headings
- Uterine Cervical Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GX-188EBiological
Also called GX-188E administered by electrophoration
In phase II study, 72 patients were assigned to two dose groups (1mg 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.
| Study group | Role | What they receive |
|---|---|---|
| Observational group | Subjects in the period less than 24 weeks after the final administration of GX-188E Receives: Biological: GX-188E |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety assessment examined by physical examination, vital signs, ECG, clinical laboratory test etc
long term safety assessment of GX-188E DNA vaccine of subjects participated in GX-188E_ CIN3_P2 clinical trial
- Safety profile would be examined by physical examination, vital signs, ECG, clinical laboratory test etc
Measured: at week -18 and 130
lesion recurrence
The change of the CIN lesion (included cervical cancer) would be compared to that of the last visit in phase II study
Measured: at week -18 and 130
Secondary outcomes (5)
The change of HPV infection status
The change of HPV infection status would be compared to that of the last visit in phase II study.
Measured: at week -18 and 130
The change of cytology test result
The change of cytology status would be compared to that of the last visit in phase II study.
Measured: at week -18 and 130
The change of the immune response
It would be determined by evaluating HPV type 16/18 E6 and E7 specific T cell response (IFN-γ ELISPOT: enzyme-linked immunospot assay) using PBMC(peripheral blood monocyte).
Measured: at week -18 and 130
Flt-3L(fms-related tyrosine kinase 3 ligand) concentration (Flt-3L ELISA) using plasma.
Pharmacodynamics evaluation of GX-188E
Measured: at week -18 and 130
Survey of pregnancy and delivery
The matters relevant to the subject of pregnancy and delivery would be collected by survey to identify occurence, frequency and characteristic.
Measured: at week -18 and 130
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2015 (estimated)
- Study startMar 2015
- Primary completionNov 2018 (estimated)
- Study completionNov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Intraepithelial Neoplasia 3Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genexine, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jong-Sup Park, M.D., Principal investigator, The Catholic University of KoreaTae-Jin Kim, M.D., Principal investigator, Cheil General Hospital & Women's Healthcare CenterJae-Kwan Lee, M.D., Principal investigator, Korea University Guro HospitalChi-Heum Cho, M.D., Principal investigator, Keimyung University Dongsan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02411019
- Sponsor's protocol ID
- GX-188E_CIN3_P2_FU
- Acronym
- GX-188E
- Status last verified
- Jul 2017
- First submitted
- 16 Mar 2015
- Last updated
- 12 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Observational, Open-label, Multi-center, Follow-up Clinical Study to Determine Recurrence of Cervical Intraepithelial Neoplasia and Evaluate the Long-term Safety of GX-188E, a DNA-based Therapeutic Vaccine, Administered Intramuscularly by Electroporation (EP) in Subjects Who Were Diagnosed With HPV(Human Papillomavirus) 16 or 18 Positive Cervical Intraepithelial Neoplasia 3 (CIN 3) and Participated in Phase 2 Trial (GX-188E_CIN3_P2)
- ClinicalTrials.gov ID
- NCT02411019
- Acronym / sponsor ID
- GX-188E / GX-188E_CIN3_P2_FU
- Conditions
- Cervical Intraepithelial Neoplasia 3
- Keywords
- Phase 2 follow up, Cervical Intraepithelial Neoplasia, Adult, Safety, Efficacy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Genexine, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2015 (actual)
- Primary completion
- Nov 2018 (estimated)
- Study completion
- Nov 2018 (estimated)
- First posted
- 8 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 participated GX-188E phase II trial(GX-188E_CIN3_P2).
Subjects will make visits 7 times for about three years from the last visit of GX-188E phase 2 trial (GX-188E_CIN3_P2).
The endpoints are to evaluate the change of immune response, involved lesion and infection status compared to that of the final visit in phase 2 trial (GX-188E_CIN3_P2).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational group | – | Biological: GX-188ESubjects in the period less than 24 weeks after the final administration of GX-188E |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The subjects who have completed the DNA vaccine administration of each dosage (1 and 4 mg).
Key inclusion criteria (2 listed)
- Those who voluntarily signed informed consent form
- The subjects who have participated in phase II trial(GX-188E_CIN3_P2)
Key exclusion criteria (3 listed)
- The subjects who didn't receive GX-188E DNA vaccine during Phase II trial (GX-188E_CIN3_P2)
- The subjects, it is difficult to participate in this study continuously
- Any other ineligible condition at the discretion of the investigator that would be ineligible to participate the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GX-188EAlso: GX-188E administered by electrophorationIn phase II study, 72 patients were assigned to two dose groups (1mg 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. | Biological | Observational group |
Primary outcome
Safety assessment examined by physical examination, vital signs, ECG, clinical laboratory test etc
Time frame: at week -18 and 130
long term safety assessment of GX-188E DNA vaccine of subjects participated in GX-188E_ CIN3_P2 clinical trial - Safety profile would be examined by physical examination, vital signs, ECG, clinical laboratory test etc
lesion recurrence
Time frame: at week -18 and 130
The change of the CIN lesion (included cervical cancer) would be compared to that of the last visit in phase II study
5 secondary outcomes
The change of HPV infection status
Time frame: at week -18 and 130
The change of cytology test result
Time frame: at week -18 and 130
The change of the immune response
Time frame: at week -18 and 130
Flt-3L(fms-related tyrosine kinase 3 ligand) concentration (Flt-3L ELISA) using plasma.
Time frame: at week -18 and 130
Survey of pregnancy and delivery
Time frame: at week -18 and 130
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2017.
Related trials for Cervical Intraepithelial Neoplasia 3
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Local Hyperthermia for the Treatment of Cervical Persistent High-risk Infection
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Not yet recruitingPhase 2
Adjuvant 5-Fluorouracil Following Thermal Ablation to Improve HPV Treatment Outcomes in Women With HIV in Kenya
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Not yet recruitingObservational study
Peripheral Blood CyTOF Immune Model for Cervical Lesion Detection in HPV16/18+ Women
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PVX4 for the Treatment of Human Papilloma Virus (HPV)16+ Cervical Dysplasia
Cervical Intraepithelial Neoplasia Grade 2/3, Human Papilloma Virus Infection Type 16
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jong-Sup Park, M.D. principal investigator
The Catholic University of Korea
Tae-Jin Kim, M.D. principal investigator
Cheil General Hospital & Women's Healthcare Center
Jae-Kwan Lee, M.D. principal investigator
Korea University Guro Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Intraepithelial Neoplasia 3, run by Genexine, Inc. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety assessment examined by physical examination, vital signs, ECG, clinical laboratory test etc (time frame: at week -18 and 130). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2017.