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Cervical Intraepithelial NeoplasiaPhase 2NCT02596243

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

A Phase 2 study testing GX-188E in people with Cervical Intraepithelial Neoplasia, run by Genexine, Inc. at 16 sites in 3 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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) Read more about this study

Who is it for?
Ages 18 to 60 years, women only
Conditions the study is for
Cervical Intraepithelial Neoplasia
What is being tested?
GX-188E
Type of treatment
Vaccines
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
134 participants
Where
16 sitesin 3 countries
Study dates
Aug 2015to Aug 2018
Phase
Phase 2
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 18 to 60 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
Show all 16Show fewer
  • 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;
  • Any other conditions judged by the investigator that would limit the evaluation of a subject.

Trial locations and contacts

16 sites in 3 countries.

16 sites in 3 countries

South Korea9 sites

  • Inje University Busan Paik Hospital

    Busan, 47392

  • Keimyung University Dongsan Medical Center

    Daegu, 41931

  • Severance Hospital

    Seoul, 03722

  • Cheil General Hospital & Women's Healthcare Center

    Seoul, 04619

  • CHA Gangnam Medical Center

    Seoul, 06135

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

    Seoul, 06591

  • Hallym University Kangnam Sacred Heart Hospital

    Seoul, 07441

  • Ehwa Womans University Mokdong Hospital

    Seoul, 07985

  • Korea University Guro Hospital

    Seoul, 080308

Other trials in South Korea

Ukraine4 sites

  • Kharkiv medical academy of postgraduate education

    Kharkiv, 61070

  • National Academy of Medical Sciences of Ukraine

    Kyiv, 04050

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

    Odesa, 65026

  • State Institution Zaporizhzhia Medical Academy of Post-Graduate Education

    Zaporizhzhya, 69071

Other trials in Ukraine

Estonia3 sites

  • East Tallinn Central Hospital

    Tallinn, 10119

  • North Estonia Medical Centre Foundation

    Tallinn, 13419

  • Tartu University Hospital

    Tartu, 51014

Other trials in Estonia

About this study

Official title: A Randomized, Double-blind, Placebo-controlled, Multi-center, Phase 2 Clinical Trial to Evaluate the Efficacy and the Safety of GX-188E, a DNA-based Therapeutic Vaccine, Administered Intramuscularly by Electroporation(EP) in HPV Type 16 and/or 18 Positive Patients With Biopsy-proven Cervical Intraepithelial Neoplasia Grade 2(CIN2), Grade 2/3 (CIN2/3), Grade 3(CIN3)

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)

Read the detailed description

Not provided

Being tested
GX-188E, Placebo
Keywords
CIN2, CIN2/3, CIN3, Cervical Intraepithelial Neoplasia, High-Risk HPV, HPV infection, precancer Diseases, Double Blind, Safety/Efficacy
Medical subject headings
Uterine Cervical Dysplasia, Papillomavirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GX-188EBiological

    Also called DNA therapeutic vaccine

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

  • PlaceboBiological

    Also called Placebo-control

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

Study groups in NCT02596243
Study groupRoleWhat they receive
GX-188EExperimentalGX-188E + EP
Receives: Biological: GX-188E
placeboPlacebo comparatorPlacebo + EP
Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 36 weeks

Secondary outcomes (1)

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

    The number of participants with clearance of HPV 16 or 18 in combination with histopathological regression of cervical lesions to CIN1 or less at the 36 week visit

    Measured: 36 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Nov 2015 (estimated)
  2. Study startAug 2015
  3. Primary completionMar 2018 (estimated)
  4. Study completionAug 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
134 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02596243
Sponsor's protocol ID
HPV-EU-001
Status last verified
Jul 2017
First submitted
3 Nov 2015
Last updated
12 Jul 2017
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GX-188E in people with Cervical Intraepithelial Neoplasia, run by Genexine, Inc. at 16 sites in 3 countries.

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 6 inclusion and 16 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 16 sites in South Korea, Ukraine, Estonia. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Number of participants with histopathological regression of cervical lesions to CIN1 or less (time frame: 36 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02596243.

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.

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