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HealthyPhase 1/2NCT03721718

Evaluate the Safety, Tolerability and Immunogenicity Study of GLS-5300 in Healthy Volunteers

A Phase 1/2 study testing GLS-5300 and Cellectra 2000 Electroporation in people with Healthy, run by GeneOne Life Science, Inc. at 2 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The Middle East Respiratory Syndrome Coronavirus (MERS CoV), is a cause of severe and highly fatal lower respiratory tract infection, first identified in 2012. As of August 2018, there have been 2229 cases reported with a case fatality rate >35%. Read more about this study

Who is it for?
Ages 19 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
GLS-5300 and Cellectra 2000 Electroporation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
2 sitesSouth Korea
Study dates
28 Aug 2018to 22 Apr 2020
Phase
Phase 1/2
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 19 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age 19-70 years;
  • Able to provide consent to participate and having signed an Informed Consent Form (ICF);
  • Able and willing to comply with all study procedures;
  • Women of child-bearing potential agree to either remain sexually abstinent, use medically effective contraception (oral contraception, barrier methods, spermicide, etc.) or have a partner who is sterile during this trials , or have a partner who is medically unable to induce pregnancy.
  • Normal screening ECG or screening ECG with no clinically significant findings;
  • Screening laboratory must be within normal limits or have only Grade 0-1 findings;
  • No history of clinically significant immunosuppressive or autoimmune disease.
  • Not currently or within the previous 4 weeks taking immunosuppressive agents (excluding inhaled, topical skin and/or eye drop-containing corticosteroids, low-dose methotrexate, or prednisone at a dose less than or equal to 10 mg/day or steroid equivalent).

Who cannot join

  • Administration of an investigational compound either currently or within 90 days of first dose;
  • Previous receipt of an investigational product for the treatment or prevention of MERS-CoV or SARS-CoV except if subject is verified to have received placebo;
  • Previous infection with MERS-CoV;
  • Administration of any vaccine within 4 weeks of first dose;
  • Administration of any monoclonal or polyclonal antibody product within 4 weeks of the first dose
  • Administration of any blood product within 3 months of first dose;
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  • Pregnancy or breast feeding or plans to become pregnant during the course of the study;
  • History of positive serologic test for HIV, hepatitis B surface antigen (HBsAg); or any potentially communicable infectious disease as determined by the Principal Investigator or Medical Monitor;
  • Positive serologic test for HIV, Hepatitis B surface antigen, or hepatitis C (exception: successful treatment with confirmation of sustained virologic response);
  • Baseline evidence of kidney disease as measured by creatinine greater than 1.5mg/dL (CKD Stage II or greater);
  • Baseline screening lab(s) with Grade 2 or higher abnormality;
  • Chronic liver disease or cirrhosis;
  • Immunosuppressive illness including hematologic malignancy, history of solid organ or bone marrow transplantation;
  • Current or anticipated concomitant immunosuppressive therapy (excluding inhaled, topical skin and/or eye drop-containing corticosteroids, low-dose methotrexate, or prednisone at a dose greater than 10 mg/day or steroid equivalent);
  • Past (within 6 months), current or anticipated treatment with TNF-α inhibitors such as infliximab, adalimumab, etanercept, or other monoclonal antibody;
  • Prior major surgery or any radiation therapy within 4 weeks of group assignment;
  • Any pre-excitation syndromes, e.g., Wolff-Parkinson-White syndrome; history of PSVT syndrome, history of prolonged QT syndrome;
  • Presence of a cardiac pacemaker or automatic implantable cardioverter defibrillator (AICD);
  • Metal implants within 20 cm of the planned site(s) of injection;
  • Presence of keloid scar formation or hypertrophic scar as a clinically significant medical condition at the planned site(s) of injection.
  • Prisoner or subjects who are compulsorily detained (involuntary incarceration) for treatment of either a physical or psychiatric illness;
  • Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements or assessment of immunologic endpoints;
  • Not willing to allow storage and future use of samples for MERS-CoV related research
  • Any illness or condition that in the opinion of the investigator may affect the safety of the subject or the evaluation of any study endpoint.
  • Presence of tattoos covering all possible injection sites.
  • Healthcare workers participating in the medical examination of patients infection with MER

Trial locations and contacts

2 sites in 1 country.

South Korea2 sites

  • Seoul National University Bundang Hospital

    Seongnam

  • Seoul National University Hospital

    Seoul

Other trials in South Korea

About this study

Official title: Phase I/IIa, Open-label, Dose Ranging Study to Evaluate the Safety, Tolerability and Immunogenicity of GLS-5300, Administered ID Followed by CELLECTRA® 2000 (Electroporation, EP)

The Middle East Respiratory Syndrome Coronavirus (MERS CoV), is a cause of severe and highly fatal lower respiratory tract infection, first identified in 2012. As of August 2018, there have been 2229 cases reported with a case fatality rate >35%. In 2015 an individual returning to South Korea served as the index case for an outbreak of 186 individuals, of who, >20% died. GLS-5300 is a DNA plasmid vaccine that expresses the MERS CoV spike (S) glycoprotein. This Phase I/IIa study will evaluate the safety, tolerability and immunogenicity of GLS-5300 administered intradermally (ID) followed by electroporation at 0.3 and 0.6 mg/dose assessing 2 and 3-dose regimens.

Read the detailed description

GLS-5300 is a DNA plasmid vaccine that expresses the MERS CoV spike (S) glycoprotein.

Conditions
Healthy
Being tested
GLS-5300, Cellectra 2000 Electroporation
Keywords
MERS CoV, MERS-CoV, Middle East Respiratory Syndrome, MERS, DNA Vaccine
Medical subject headings
Coronavirus Infections

What participants receive

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

  • GLS-5300Biological

    [Part A] GLS-5300 0.3 mg at 0, 4, and 12 weeks (N=5) [Part B] GLS-5300 0.3 mg at 0, 4, and 12 weeks (N=5) GLS-5300 0.6 mg at 0, 4, and 12 weeks (N=25) GLS-5300 0.6 mg at 0 and 8 weeks (N=25)

  • Cellectra 2000 ElectroporationDevice

    GLS-5300 administered ID followed by Cellectra 2000 Electroporation

Study groups in NCT03721718
Study groupRoleWhat they receive
GLS-5300 with ID Cellectra electroporationExperimentalGLS-5300 at 0.3mg DNA/dose
Receives: Biological: GLS-5300; Device: Cellectra 2000 Electroporation
GLS-5300 at 0.3mg DNA/dose with ID Cellectra electroporationExperimentalGLS-5300 at 0.3mg DNA/dose
Receives: Biological: GLS-5300; Device: Cellectra 2000 Electroporation
GLS-5300 at 0.6mg DNA/dose (3 dose regimen)ExperimentalGLS-5300 at 0.6mg DNA/dose with ID Cellectra electroporation
Receives: Biological: GLS-5300; Device: Cellectra 2000 Electroporation
GLS-5300 at 0.6mg DNA/dose (2 dose regimen)ExperimentalGLS-5300 at 0.6mg DNA/dose with ID Cellectra electroporation
Receives: Biological: GLS-5300; Device: Cellectra 2000 Electroporation

What is being measured

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

  1. Incidence of adverse events

    Incidence of Adverse events by System organ class (SOC); preferred term (PT); severity and relationship to study treatment and schedule

    Measured: Day0 through up to 60 weeks

  2. Administration (injection) site reactions

    Administration (injection) site reactions described by frequency

    Measured: Day0 through up to 60 weeks

  3. Changes in safety laboratory parameters

    Number of participants with changes based on frequency in safety lab parameters in Complete Blood Count and Liver panel tests" or similar.

    Measured: Day0 through up to 60 weeks

  4. Administration (injection) site pain

    Administration (injection) site pain as described by Visual Analog Scale (VAS)

    Measured: Administration (injection) site pain

Secondary outcomes (3)

  1. Cellular Immune Responses

    Antigen specific cellular immune responses to MERS-CoV as determined by Interferon-gamma (IFN-γ) ELISpot

    Measured: Day0 through up to 60 weeks

  2. Binding antibody titers

    Binding antibody titers against MERS-CoV for a 2 and 3 dose vaccination regimens

    Measured: Day0 through up to 60 weeks

  3. Neutralizing antibodies

    Titers of neutralizing antibodies against MERS-CoV

    Measured: Day0 through up to 60 weeks

Timeline

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

  1. First posted26 Oct 2018
  2. Study start28 Aug 2018
  3. Primary completion30 May 2019
  4. Study completion22 Apr 2020

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 1/2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03721718
Sponsor's protocol ID
MERS-002
Status last verified
May 2020
First submitted
11 Sep 2018
Last updated
27 May 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing GLS-5300 and Cellectra 2000 Electroporation in people with Healthy, run by GeneOne Life Science, Inc. at 2 sites 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 8 inclusion and 26 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: finished, as of the sponsor's last update on 27 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Incidence of adverse events (time frame: Day0 through up to 60 weeks). The study lists 4 primary outcomes in all. 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 NCT03721718.

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 27 May 2020.

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