Study of COVID-19 DNA Vaccine (AG0301-COVID19)

Study Overview
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Brief Summary
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This study will assess the safety and immunogenicity of AG0301-COVID19 in healthy adult volunteers.

Detailed Description
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This is a Phase 1/2, single-center, non-randomised, open-label, non-controlled trial. Approximately 30 healthy volunteers, male or female, aged 20-65, will be enrolled in the low dose group for the first 15 and the high dose group for the remaining 15. Low dose group: 1.0 mg AG0301-COVID19 intramuscular (IM) (n = 15) High dose group: 2.0 mg AG0301-COVID19 IM (n = 15)

Official Title
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A Non-randomized, Open-label, Non-controlled Phase I/II Study to Assess Safety and Immunogenicity of Two Doses of Intramuscular AG0301-COVID19 (1mg/2mg) in Healthy Adults

Conditions
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COVID-19

Intervention / Treatment
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* Biological: AG0301-COVID19
* Biological: AG0301-COVID19


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who have obtained written consent voluntarily to participate in this clinical trial Subjects whose age at the time of obtaining consent is 20 years to 65 years Subjects who are negative for SARS-CoV-2 by PCR test Subjects who are negative for both SARS-CoV-2 IgM antibody and SARS-CoV-2 IgG antibody by antibody test Exclusion Criteria: Subjects with symptoms of suspected COVID-19 infection (respiratory symptoms, headache, malaise, olfactory disorders, taste disorders, etc.) Subjects with a history of COVID-19 (hearing from subjects) Subjects who have participated in unapproved vaccine clinical trials Subjects with axillary temperature of 37.0 degree or higher Subjects who have a history of anaphylaxis Subjects who have serious renal, liquid, respiratory, liver, kidney, digestive, and neuropsychiatric history has a current medical history Subjects with a history of convulsion or epilepsy Subjects with a history of diagnosis of immunodeficiency Subjects who have a close relative (within 3rd degree) of congenital immunodeficiency Subjects who have a history of bronchial asthma Subjects who had a fever of 39.0°C or higher within 2 days after the last vaccination, and those who suspected allergy such as a systemic rash Females who wish to become pregnant from the date of study registration to 12 weeks after the first inoculation of the investigational drug, and pregnant females who are breast-feeding. In addition, females who may become pregnant and their male sexual partners should use appropriate contraceptives (pill), condoms, vasectomy, tubal ligation, diaphragm, intrauterine devices, spermicides, intrauterine hormone-releasing system, etc. from the study entry date until 12 weeks after vaccination Subjects who have participated in clinical trials of other unapproved drugs and received the investigational drug within 4 weeks before the start of this clinical trial (starting from vaccination day) Subjects who have been received a live vaccine, inactivated vaccine, or toxoid within 4 weeks before the start of this clinical trial (starting from vaccination day) Subjects who have been administered with drugs that affect the immune system (excluding external preparations) such as immunomodulators (DMARDs, etc.), immunosuppressants, biologics, etc. within 4 weeks from vaccination Subjects who received blood transfusion or gamma globulin therapy within 12 week before vaccination, or high-dose gamma globulin therapy (200 mg/kg or more) within 24 weeks before vaccination Subjects who have a history of overseas travel within 4 weeks before the start of the clinical trial (starting from vaccination day) Subjects who are unable to comply with the clinical trial protocol and follow up (for mental, family, social or geographical reasons) Subjects who are judged to be ineligible for this clinical trial by the investigator

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low-dose group<br> | Biological: AG0301-COVID19<br>* 1.0 mg of AG0301-COVID19 twice at 2-week intervals<br>|
| Experimental: High-dose group<br> | Biological: AG0301-COVID19<br>* 2.0 mg of AG0301-COVID19 twice at 2-week intervals<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Frequency and severity of each adverse event, solicited local and systemic AEs 8 weeks after first vaccination | Week 1 through Week 9 | 
| Immunogenicity | Change in Geometric mean titer (GMT) of serum anti-SARS-CoV-2 spike (S) glycoprotein-specific antibody | Weeks 3, 5, 7, 9 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in GMT of anti-SARS-CoV-2 spike (S) glycoprotein-specific antibody |  | Weeks 13, 25, 53 | 
| Change in GMT of anti-SARS-CoV-2 Spike (S) glycoprotein receptor binding domain-specific antibody |  | Weeks 3, 5, 7, 9, 13, 25, 53 | 
| Change in GMT of anti-SARS-CoV-2 B cell epitope antibody |  | Weeks 3, 5, 7, 9, 13, 25, 53 | 
| Change in IgG subclasses (IgG1 and IgG2) of anti-SARS-CoV-2 spike (S) glycoprotein-specific antibody |  | Weeks 3, 5, 7, 9, 13, 25, 53 | 
| Adverse events |  | Week 9 through Week 53 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vaccine, COVID-19, SARS-CoV-2