GLS-5310 Vaccine for the Prevention of SARS-CoV-2 (COVID-19)

This Phase I / IIa study will assess the safety, tolerability, and immunogenicity of GLS-5310 DNA vaccine.

The Phase I portion of this study is an open-label, dose escalation study to assess two dose levels of GLS-5310 DNA vaccine (0.6 and 1.2 mg) as part of two vaccination regimens (0-8 weeks and 0-12 weeks).

The Phase IIa portion of this study is designed as a randomized, double-blind, placebo-controlled study with only a single active study drug arm. Subjects will be randomized to receive either placebo or GLS-5310 vaccine in a 1:2 ratio.

Inclusion criteria

• Age 19 to 85 years of age (Phase I will be restricted to an upper age limit of 50 years of age)
• Able to provide informed consent
• Able and willing to comply with study procedures
• For women of childbearing potential, able and willing to use an approved form of pregnancy prevention through to 4 weeks post boost vaccination

Exclusion criteria

• Current or planned pregnancy through to 4 weeks post-boost vaccination for women of childbearing potential
• Currently breastfeeding
• Current or past participation in a coronavirus (MERS-CoV, SARS-CoV-2) vaccine study
• Administration of an investigational agent within 6 months of the 1st dose
• Administration of a vaccine within 4 weeks prior to the 1st dose
• Administration of immune globulin within 16 weeks of enrollment
• Administration of an anti-TNFα inhibitor such as infliximab, adalimumab, etanercept, or anti-CD20 monoclonal antibody rituximab within 24 weeks prior to enrollment
• Current daily treatment of systemic corticosteroids of 20 mg of prednisone or greater, dexamethasone of 3 mg or greater; or the equivalent dose of other systemic corticosteroids
• Administration of any Immunosuppressive Drug or Immunomodulator within 3 months of the first dose
• History of bone marrow transplantation
• Current or planned chemotherapy treatment for hematologic or solid tumor during study period or treatment during the 5 years prior to enrollment
• Respiratory disease (ex. Asthma, Chronic obstructive lung disease)
• Cardiovascular disease (ex. myocardial ischemia, congestive heart failure, cardiomyopathy, clinically significant arrhythmia)
• Hypertension (Systolic pressure >150mmHg or Diastolic pressure >95mmHg)
• Confirmed Diabetes
• Severe allergic reaction or anaphylactic reaction after vaccination in the past
• Immunosuppresion including immunodeficiency disease or family history
• Positive of serum test at screening (Hepatitis B, Hepatitis A, HIV, Hepatitis C)
• Baseline screening lab(s) with Non Clinical Significant abnormality
• Serious adverse reaction to a drug containing Investigational Product (GLS-5310) or other ingredients of the same categories or to a vaccine or antibiotic, nonsteroidal anti-inflammatory disease control, etc. or an allergic history
• History of hypersensitivity to vaccination such as Guillain-Barre syndrome
• History of PCR-confirmed infection with SARS-CoV-2 at screening
• Subjects who have been contact with COVID-19 infections in the past prior to administration, have been classified as COVID-19 confirmed patients, medical patients or patients with symptoms or have been identified with SARS and MERS infection history in the past
• 37.5 degrees, cough, difficulty breathing, chills, muscle aches, headache, sore throat, loss of smell, or loss of taste within 72 hours prior to administration
• Healthcare workers participating in the medical examination of patients infected with COVID-19
• Not willing to allow storage and future use of samples for SARS-CoV-2 related research
• Prisoner or subjects who are compulsorily detained for treatment of a psychiatric illness
• Any illness or condition that, in the opinion of the investigator, may affect the safety of the subject or the evaluation of a study endpoint