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HealthyPhase 1NCT02670187

Phase I, Open Label Dose Ranging Safety Study of GLS-5300 in Healthy Volunteers

A Phase 1 study testing GLS-5300 in people with Healthy, run by GeneOne Life Science, Inc. at 1 site in United States.

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), a virus related to Severe Acute respiratory syndrome coronavirus (SARS CoV), was first recognized as a cause of severe pulmonary infection in 2012. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
GLS-5300
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
1 siteUnited States
Study dates
Feb 2016to Sep 2017
Phase
Phase 1
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 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Age 18-50 years; military, civilian, male and female.
  • Able to provide consent to participate and having signed an Informed Consent Form.
  • Able and willing to comply with all study procedures.
  • Women of child-bearing potential agree to remain sexually abstinent, use medically effective contraception (oral contraception, barrier methods, spermicide, etc.) or have a partner who is sterile from enrollment to 3 months following the last injection, or have a partner who is unable to induce pregnancy.
  • Sexually active men who are considered sexually fertile must agree to use either a barrier method of contraception during the study, and agree to continue the use for at least 3 months following the last injection, or have a partner who is permanently sterile or unable to become pregnant;
  • Normal screening ECG or screening ECG with no clinically significant findings;
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  • Screening labs 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 corticosteroids at a dose less than 20 mg/day).
  • Willing to allow storage and future use of samples for MERS CoV related research

Who cannot join

  • Administration of an investigational compound either currently or within 30 days of first dose;
  • Previous receipt of an investigational product for the treatment or prevention of MERS CoV except if participant is verified to have received placebo;
  • Previous infection with MERS CoV as assessed by self report and solicited exposure history;
  • Administration of any vaccine within 4 weeks of first dose;
  • A BMI greater than or equal to 35;
  • Administration of any monoclonal or polyclonal antibody product within 4 weeks of the first dose;
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  • Administration of any blood product within 3 months of first dose;
  • Pregnancy or breast feeding or have 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 hepatitis C (exception: successful treatment with confirmation of sustained virologic response);
  • Baseline evidence of kidney disease as measured by creatinine greater than 1.5 (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 corticosteroids at a dose less than 20 mg/day);
  • Current or anticipated treatment with TNF-α inhibitors such as infliximab, adalimumab, etanercept;
  • Prior major surgery or any radiation therapy within 4 weeks of group assignment;
  • Any pre-excitation syndromes, e.g., Wolff-Parkinson-White 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 participants 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; or
  • Tattoos covering the injection site area h
  • Any illness or condition that in the opinion of the investigator may affect the safety of the participant or the evaluation of any study endpoint.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Walter Reed Institute of Research

    Silver Spring, Maryland, 20910

Other trials in United States

About this study

Official title: Phase I, Open-label, Dose Ranging Study to Evaluate the Safety, Tolerability, and Immunogenicity of GLS-5300, Administered IM Followed by Electroporation in Healthy Volunteers

The Middle East Respiratory Syndrome Coronavirus (MERS CoV), a virus related to Severe Acute respiratory syndrome coronavirus (SARS CoV), was first recognized as a cause of severe pulmonary infection in 2012. Infection with MERS CoV has been diagnosed in more than 1600 individuals with a mortality rate between 35% and 40%. GLS-5300 is a DNA plasmid vaccine that expresses the MERS CoV spike (S) glycoprotein. This study will evaluate the safety of GLS-5300 at one of three dose levels following a three-injection vaccination regimen followed by electroporation. The study will also assess immune responses over a 1 year period with respect to the generation of antibody and cellular responses.

Read the detailed description

GLS-5300 is a DNA plasmid vaccine that expresses the MERS CoV spike (S) glycoprotein. Following administration of the vaccine, a specialized medical device, CELLECTRA®, will deliver brief electrical pulses in a process known as electroporation (EP), to help move DNA into cells more efficiently.

Conditions
Healthy
Being tested
GLS-5300
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

Study groups in NCT02670187
Study groupRoleWhat they receive
GLS-5300ExperimentalGLS-5300 at 0.67 mg DNA/dose
Receives: Biological: GLS-5300
GLS-5300 at 2 mg DNA/doseExperimentalGLS-5300 at 2 mg DNA/dose
Receives: Biological: GLS-5300
GLS-5300 at 6 mg DNA/doseExperimentalGLS-5300 at 6 mg DNA/dose
Receives: Biological: GLS-5300

What is being measured

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

  1. Mean change from baseline in safety laboratory measures

    Measured: Day0 through Week 60

  2. Incidence of solicited adverse events after vaccination

    Measured: Day0 through Week 60

  3. Incidence of unsolicited adverse events after vaccination

    Measured: Day0 through Week 60

  4. Incidence of serious adverse events

    Measured: Day0 through Week 60

Secondary outcomes (3)

  1. Binding antibody response to S protein

    Measured: Day0 through Week 60 following the first dose

  2. Neutralizing antibody response to S protein

    Measured: Day0 through Week 60 following the first dose

  3. T cell response

    Measured: Day 0 through Week 60 following the first dose

Timeline

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

  1. First posted1 Feb 2016 (estimated)
  2. Study startFeb 2016
  3. Primary completionMay 2017
  4. Study completionSep 2017

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
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02670187
Sponsor's protocol ID
WRAIR 2274
Status last verified
Jan 2019
First submitted
27 Jan 2016
Last updated
9 Jan 2019
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes

Publications

  • Modjarrad K, Roberts CC, Mills KT, Castellano AR, Paolino K, Muthumani K, Reuschel EL, Robb ML, Racine T, Oh MD, Lamarre C, Zaidi FI, Boyer J, Kudchodkar SB, Jeong M, Darden JM, Park YK, Scott PT, Remigio C, Parikh AP, Wise MC, Patel A, Duperret EK, Kim KY, Choi H, White S, Bagarazzi M, May JM, Kane D, Lee H, Kobinger G, Michael NL, Weiner DB, Thomas SJ, Maslow JN. Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial. Lancet Infect Dis. 2019 Sep;19(9):1013-1022. doi: 10.1016/S1473-3099(19)30266-X. Epub 2019 Jul 24.

    PubMed 31351922

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GLS-5300 in people with Healthy, run by GeneOne Life Science, Inc. at 1 site in United States.

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 10 inclusion and 25 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 9 Jan 2019. 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 United States. 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 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.

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?

Mean change from baseline in safety laboratory measures (time frame: Day0 through Week 60). 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 NCT02670187, which also lists 1 linked publication.

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 9 Jan 2019.

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