Phase 2 Clinical Trial to Evaluate the Safety and Efficacy of Plasmid DNA Therapeutic Vaccine(GX-188E)

NCT02596243 | Unknown Phase 2 DMC

• 1 other identifier: HPV-EU-001
• Study Type: interventional
• Target: 134
• Locations: 3 countries
• Sites: 16

Brief Summary

The purpose of this study is to access the efficacy and safety of GX-188E according the protocol in patients with Cervical Intraepithelial Neoplasia 2, 2/3 or 3 (CIN3)

Conditions

Cervical Intraepithelial Neoplasia

Keywords

CIN2, CIN2/3, CIN3; Cervical Intraepithelial Neoplasia; High-Risk HPV; HPV infection; precancer Diseases; Double Blind; Safety/Efficacy

Outcome Measures

Primary Outcomes (1)

• Number of participants with histopathological regression of cervical lesions to CIN1 or less

  The number of participants with cervical lesions regress to CIN1 or less at the 36 week visit

  36 weeks

Secondary Outcomes (1)

• Number of participants with Clearance of HPV 16 or 18 in combination with histopathological regression of cervical lesions to CIN1 or less

  36 weeks

Study Arms (2)

GX-188E

EXPERIMENTAL

GX-188E + EP

Biological: GX-188E

placebo

PLACEBO COMPARATOR

Placebo + EP

Biological: Placebo

Interventions

GX-188E BIOLOGICAL

1mg of GX-188E administered IM using EP device at day 0, week 4 and week 12.

Also known as: DNA therapeutic vaccine

GX-188E

Placebo BIOLOGICAL

0.5mL of Placebo administered IM using EP device at day 0, week 4 and week 12.

Also known as: Placebo-control

placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female subjects age 18-60 years
• Histologically confirmed HPV-16 or HPV-18 asspcoated CIN2, CIN 2/3 or CIN3 from tissue collected less than 10 weeks prior to Vaccination/EP #1 with overall lesion sizes less than 50% of the cervix area and no evidence of invasive cancer in any specimen;
• Colposcopy is satisfactory based on visualization of the entire squamocolumnar junction and the upper limit of the entire aceto-white or suspected CIN disease area;
• Healthy subjects as judged by the Investigator based on medical history, PE, and normal results for an ECG, CBC, Serum Chemistries, CPK and urinalysis done up to 4 weeks prior to enrolment;
• For women who are not postmenopausal (at least 12 months of nontherapy- induced amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to remain abstinent or use a highly effective method of contraception during the treatment period and throughout Week 36 response evaluation visit.
• Able and willing to comply with all study procedures and voluntarily signs informed consent form.

You may not qualify if:

• Unsatisfactory colposcopy defined as incomplete visualization of the entire squamocolumnar junction and the upper limit of the entire aceto-white or suspected CIN disease area;
• Pregnancy or breastfeeding;
• Immunosuppression including any concurrent condition requiring the continued use of systemic or topical steroids at or near the injection site \[deltoid, upper arm\] (excluding inhaled and eye drop-containing corticosteroids) or the use of immunosuppressive agents. All other corticosteroids must be discontinued \> 4 weeks prior to Day 0 of study vaccine administration; autoimmune disorders, transplant recipients;
• History of previous therapeutic HPV vaccination (individuals who have been immunized with licensed prophylactic HPV vaccines (e.g. Gardasil®, Cervarix®) are not excluded);
• Positive serological test for hepatitis C virus or hepatitis B virus surface antigen (HBsAg) or human immunodeficiency virus (HIV);
• Administration of any blood product within 3 months of enrollment;
• Administration of any licensed vaccine within 2 weeks of enrollment (4 weeks for measles vaccine);
• Participation in a study with an investigational compound or device within 30 days prior to signing informed consent;
• Cardiac pre-excitation syndromes (such as Wolff-Parkinson-White);
• History of seizures (unless seizure free for 5 years);
• Tattoos, scars, active lesions/rashes or any implantable leads within 3 cm of the intended site of vaccination/EP;
• Any electronic medical implants (such as cardiac pacemaker);
• Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements;
• A tendency for severe haemorrhage following acute trauma;
• Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (i.e. infections disease) illness must not be enrolled into this study;

Sponsors & Collaborators

• Genexine, Inc.: lead

Study Sites (16)

East Tallinn Central Hospital

Tallinn, 10119, Estonia

Location

North Estonia Medical Centre Foundation

Tallinn, 13419, Estonia

Location

Tartu University Hospital

Tartu, 51014, Estonia

Location

Inje University Busan Paik Hospital

Busan, 47392, South Korea

Location

Keimyung University Dongsan Medical Center

Daegu, 41931, South Korea

Location

Severance Hospital

Seoul, 03722, South Korea

Location

Cheil General Hospital & Women's Healthcare Center

Seoul, 04619, South Korea

Location

CHA Gangnam Medical Center

Seoul, 06135, South Korea

Location

The Catholic University of Korea Seoul St. Mary's Hospital

Seoul, 06591, South Korea

Location

Hallym University Kangnam Sacred Heart Hospital

Seoul, 07441, South Korea

Location

Ehwa Womans University Mokdong Hospital

Seoul, 07985, South Korea

Location

Korea University Guro Hospital

Seoul, 080308, South Korea

Location

Kharkiv medical academy of postgraduate education

Kharkiv, 61070, Ukraine

Location

National Academy of Medical Sciences of Ukraine

Kyiv, 04050, Ukraine

Location

Multi-profile Medical Center (University Clinic No. 1) of Odesa National

Odesa, 65026, Ukraine

Location

State Institution Zaporizhzhia Medical Academy of Post-Graduate Education

Zaporizhzhya, 69071, Ukraine

Location

MeSH Terms

Conditions

Uterine Cervical Dysplasia; Papillomavirus Infections

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; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Terje Raud, MD

  Tartu University Hospital

  PRINCIPAL INVESTIGATOR

• Kersti Kukk, MD

  North Estonia Medical Centre Foundation

  PRINCIPAL INVESTIGATOR

• Aira Peri, MD

  East Tallinn Central Hospital

  PRINCIPAL INVESTIGATOR

• Tetiana Tatarchuk, MD

  National Academy of Medical Sciences of Ukraine

  PRINCIPAL INVESTIGATOR

• Nataliya Lutsenko, MD

  State Institution, Zaporizhzhia Medical Academy of Post-Graduate Education Ministry of Health of Ukraine

  PRINCIPAL INVESTIGATOR

• Sergiy Kartashov, MD

  Kharkiv medical academy of postgraduate education

  PRINCIPAL INVESTIGATOR

• Natalia Rozhkovska, MD

  Multi-profile Medical Center (University Clinic No. 1) of Odesa National Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2015
• First Posted: November 4, 2015
• Study Start: August 1, 2015
• Primary Completion: March 1, 2018
• Study Completion: August 1, 2018
• Last Updated: July 12, 2017

Record last verified: 2017-07

Locations

UA (4); KR (9); ES (3)