SARS-CoV-2
Conditions
Keywords
COVID-19
Brief summary
This clinical trial will evaluate the safety, tolerability and immunogenicity of GLS-5310 DNA vaccine against SARS-CoV-2(COVID-19) in healthy volunteers.
Detailed description
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.
Interventions
BIOLOGICALGLS-5310
GLS-5310 DNA plasmid vaccine
BIOLOGICALPlacebo
Placebo
Sponsors
GeneOne Life Science, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
1. Age 19 to 85 years of age (Phase I will be restricted to an upper age limit of 50 years of age) 2. Able to provide informed consent 3. Able and willing to comply with study procedures 4. 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
1. Current or planned pregnancy through to 4 weeks post-boost vaccination for women of childbearing potential 2. Currently breastfeeding 3. Current or past participation in a coronavirus (MERS-CoV, SARS-CoV-2) vaccine study 4. Administration of an investigational agent within 6 months of the 1st dose 5. Administration of a vaccine within 4 weeks prior to the 1st dose 6. Administration of immune globulin within 16 weeks of enrollment 7. Administration of an anti-TNFα inhibitor such as infliximab, adalimumab, etanercept, or anti-CD20 monoclonal antibody rituximab within 24 weeks prior to enrollment 8. 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 9. Administration of any Immunosuppressive Drug or Immunomodulator within 3 months of the first dose 10. History of bone marrow transplantation 11. Current or planned chemotherapy treatment for hematologic or solid tumor during study period or treatment during the 5 years prior to enrollment 12. Respiratory disease (ex. Asthma, Chronic obstructive lung disease) 13. Cardiovascular disease (ex. myocardial ischemia, congestive heart failure, cardiomyopathy, clinically significant arrhythmia) 14. Hypertension (Systolic pressure \>150mmHg or Diastolic pressure \>95mmHg) 15. Confirmed Diabetes 16. Severe allergic reaction or anaphylactic reaction after vaccination in the past 17. Immunosuppresion including immunodeficiency disease or family history 18. Positive of serum test at screening (Hepatitis B, Hepatitis A, HIV, Hepatitis C) 19. Baseline screening lab(s) with Non Clinical Significant abnormality 20. 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 21. History of hypersensitivity to vaccination such as Guillain-Barre syndrome 22. History of PCR-confirmed infection with SARS-CoV-2 at screening 23. 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 24. 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 25. Healthcare workers participating in the medical examination of patients infected with COVID-19 26. Not willing to allow storage and future use of samples for SARS-CoV-2 related research 27. Prisoner or subjects who are compulsorily detained for treatment of a psychiatric illness 28. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Serious Adverse Events | Through 48 weeks post vaccination |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants With Positive T Cell Responses Induced by GLS-5310 | Post vaccination Visit 4 (4 weeks after week 8 or week 12 vaccination) |
| Number of Participants With Positive Neutralizing Antibody Responses Induced by GLS-5310 | Post vaccination Visit 4 (4 weeks after week 8 or week 12 vaccination) |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| GLS-5310 0.6mg [Group 1a] 0.6mg of GLS-5310 will be intradermally administered on Day 0 and Week 8.
GLS-5310: GLS-5310 DNA plasmid vaccine | 15 |
| GLS-5310 1.2mg [Group 1b] 1.2mg of GLS-5310 will be intradermally administered on Day 0 and Week 8.
GLS-5310: GLS-5310 DNA plasmid vaccine | 15 |
| GLS-5310 1.2mg [Group 1c] 1.2mg of GLS-5310 will be intradermally administered on Day 0 and Week 12.
GLS-5310: GLS-5310 DNA plasmid vaccine | 15 |
| Placebo [Group 2a] Placebo will be intradermally administered on Day 0 and Week 8 (or Week 12).
Placebo: Placebo | 42 |
| GLS-5310 1.2mg [Group 2b] 1.2mg of GLS-5310 will be intradermally administered on Day 0 and Week 8 (or Week 12).
GLS-5310: GLS-5310 DNA plasmid vaccine | 84 |
| Total | 171 |
Baseline characteristics
| Characteristic | GLS-5310 0.6mg [Group 1a] | GLS-5310 1.2mg [Group 1b] | GLS-5310 1.2mg [Group 1c] | Placebo [Group 2a] | GLS-5310 1.2mg [Group 2b] | Total |
|---|---|---|---|---|---|---|
| Age, Customized Age 19-66 | 15 Participants | 15 Participants | 15 Participants | 42 Participants | 80 Participants | 167 Participants |
| Age, Customized Age >66-85 | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 4 Participants | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 15 Participants | 15 Participants | 15 Participants | 42 Participants | 84 Participants | 171 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 9 Participants | 9 Participants | 14 Participants | 31 Participants | 64 Participants | 127 Participants |
| Sex: Female, Male Male | 6 Participants | 6 Participants | 1 Participants | 11 Participants | 20 Participants | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 | 0 / 15 | 0 / 44 | 0 / 82 |
| other Total, other adverse events | 15 / 15 | 15 / 15 | 15 / 15 | 33 / 44 | 82 / 82 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 | 0 / 15 | 0 / 44 | 0 / 82 |
Outcome results
Primary
Number of Serious Adverse Events
Time frame: Through 48 weeks post vaccination
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GLS-5310 0.6mg [Group 1a] | Number of Serious Adverse Events | 0 serious adverse events |
| GLS-5310 1.2mg [Group 1b] | Number of Serious Adverse Events | 0 serious adverse events |
| GLS-5310 1.2mg [Group 1c] | Number of Serious Adverse Events | 0 serious adverse events |
| Placebo [Group 2a] | Number of Serious Adverse Events | 0 serious adverse events |
| GLS-5310 1.2mg [Group 2b] | Number of Serious Adverse Events | 0 serious adverse events |
Secondary
Number of Participants With Positive Neutralizing Antibody Responses Induced by GLS-5310
Time frame: Post vaccination Visit 4 (4 weeks after week 8 or week 12 vaccination)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GLS-5310 0.6mg [Group 1a] | Number of Participants With Positive Neutralizing Antibody Responses Induced by GLS-5310 | 4 Participants |
| GLS-5310 1.2mg [Group 1b] | Number of Participants With Positive Neutralizing Antibody Responses Induced by GLS-5310 | 5 Participants |
| GLS-5310 1.2mg [Group 1c] | Number of Participants With Positive Neutralizing Antibody Responses Induced by GLS-5310 | 6 Participants |
| Placebo [Group 2a] | Number of Participants With Positive Neutralizing Antibody Responses Induced by GLS-5310 | 2 Participants |
| GLS-5310 1.2mg [Group 2b] | Number of Participants With Positive Neutralizing Antibody Responses Induced by GLS-5310 | 7 Participants |
Secondary
Number of Participants With Positive T Cell Responses Induced by GLS-5310
Time frame: Post vaccination Visit 4 (4 weeks after week 8 or week 12 vaccination)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GLS-5310 0.6mg [Group 1a] | Number of Participants With Positive T Cell Responses Induced by GLS-5310 | 14 Participants |
| GLS-5310 1.2mg [Group 1b] | Number of Participants With Positive T Cell Responses Induced by GLS-5310 | 12 Participants |
| GLS-5310 1.2mg [Group 1c] | Number of Participants With Positive T Cell Responses Induced by GLS-5310 | 14 Participants |
| Placebo [Group 2a] | Number of Participants With Positive T Cell Responses Induced by GLS-5310 | 14 Participants |
| GLS-5310 1.2mg [Group 2b] | Number of Participants With Positive T Cell Responses Induced by GLS-5310 | 24 Participants |