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

G

GeneOne Life Science

Status and phase

Completed
Phase 2
Phase 1

Conditions

Healthy

Treatments

Device: Cellectra 2000 Electroporation
Biological: GLS-5300

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT03721718
MERS-002

Details and patient eligibility

About

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.

Full description

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

Enrollment

60 patients

Sex

All

Ages

19 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • 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).

Exclusion criteria

  • 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;
  • 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 design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 4 patient groups

GLS-5300 with ID Cellectra electroporation
Experimental group
Description:
GLS-5300 at 0.3mg DNA/dose
Treatment:
Biological: GLS-5300
Device: Cellectra 2000 Electroporation
GLS-5300 at 0.3mg DNA/dose with ID Cellectra electroporation
Experimental group
Description:
GLS-5300 at 0.3mg DNA/dose
Treatment:
Biological: GLS-5300
Device: Cellectra 2000 Electroporation
GLS-5300 at 0.6mg DNA/dose (3 dose regimen)
Experimental group
Description:
GLS-5300 at 0.6mg DNA/dose with ID Cellectra electroporation
Treatment:
Biological: GLS-5300
Device: Cellectra 2000 Electroporation
GLS-5300 at 0.6mg DNA/dose (2 dose regimen)
Experimental group
Description:
GLS-5300 at 0.6mg DNA/dose with ID Cellectra electroporation
Treatment:
Biological: GLS-5300
Device: Cellectra 2000 Electroporation

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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