A phase ? study to evaluate the safety of GX-188E administered by electroporation in DNA-based therapeutic vaccine for patients with Cervical Intraepithelial Neoplasia grade 3 (CIN 3)

A single center, open-label, dose-escalating, Phase ? study to evaluate the safety of GX-188E administered by electroporation (EP) in DNA-based therapeutic vaccine for patients with Cervical Intraepithelial Neoplasia grade 3 (CIN 3)

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CRIS

Registry ID

KCT0000586

Enrollment

Registered

2012-11-22

Start date

2012-11-12

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug, Medical Device : Investigational Product: GX-188E, provided in vials for intramuscular injections. Dose: 1mg, 2mg or 4mg of GX-188E will be administered per groups respetively.

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1)Female aged between 20 and 50 years 2)Those who promised not to get pregnant from the participation to the study until the first F/U visit (VF1) 3)Histologically confirmed HPV-16 or HPV-18 associated Cervical Intraepithelial Neoplasia grade 3 (CIN 3) 4)Those who voluntarily signed informed consent form

Exclusion criteria

Exclusion criteria: 1)Pregnant or lactating women 2)Administration of immunosuppressant or immunomodulator within 6 months prior to the enrollment 3)Concomitant medication of any corticosteroid agents within 4 weeks prior to vaccination with the test drug (Day 0) 4)Prior immunotherapy against HPV 5)Administration of any blood products within 3 months prior to the screening visit 6)Administration of any vaccine within 4 weeks prior to the screening visit (ex. Hepatitis A vaccine, Hepatitis B vaccine, Influenza vaccine, Td etc.) 7)Positive serum test results for hepatitis C virus, hepatitis B virus surface antigen(HBsAg), or HIV 8)Prior participation in any clinical trial within 30 days prior to the screening visit 9)Patients predisposed to inflammatory reaction due to use of medical devices such as electroporation within 30 days of screening visit 10)Past history of epilepsy or convulsion within 2 years prior to the screening visit 11)At the discretion of the investigator, the skin condition covering deltoid muscles, within 2cm of the intended sites of injection, is not suitable for injection due to infection, ulcer, edema, tattoo, scar, injury etc. 12)The thickness of skin fold covering deltoid muscles, intended injection sites, >40mm 13)Any orthopedic artificial implant around the intended sites of electroporation (deltoid muscles) 14)Any history of severe adverse drug events or severe allergic diseases 15)Sinus bradycardia whose resting heart rate < 50beats/min. 16)Pre-excitation syndrome such as Wolff-Parkinson-White syndrome 17)Artificial implants or metallic implants 18)Abnormal electrocardiography (ECG) including arrhythmia 19)Any other ineligible condition at the discretion of the investigator that would be ineligible to participate the study

Design outcomes

Primary

Measure	Time frame
Safety profile(vital signs, physical examination, adverse events, clinical laboratory tests etc.)	—

Secondary

Measure	Time frame
the expression levels of GX-188E in blood;Immune Response (IFN-? ELISPOT assay);the changes of the involved lesions and HPV infection status	—

Countries

Korea, Republic of

Contacts

Public ContactPil Ju Lim

Cheil General Hospital & Women's healthcare center

Outcome results