Study of COVID-19 DNA Vaccine (AG0301-COVID19)
Study Details
Study Description
Brief Summary
This study will assess the safety and immunogenicity of AG0301-COVID19 in healthy adult volunteers.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
Detailed Description
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)
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Low-dose group
|
Biological: AG0301-COVID19
1.0 mg of AG0301-COVID19 twice at 2-week intervals
|
| Experimental: High-dose group
|
Biological: AG0301-COVID19
2.0 mg of AG0301-COVID19 twice at 2-week intervals
|
Outcome Measures
Primary Outcome Measures
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [Week 1 through Week 9]
Frequency and severity of each adverse event, solicited local and systemic AEs 8 weeks after first vaccination
- Immunogenicity [Weeks 3, 5, 7, 9]
Change in Geometric mean titer (GMT) of serum anti-SARS-CoV-2 spike (S) glycoprotein-specific antibody
Secondary Outcome Measures
- 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]
Eligibility Criteria
Criteria
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)
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Subjects who have participated in unapproved vaccine clinical trials
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Subjects with axillary temperature of 37.0 degree or higher
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Subjects who have a history of anaphylaxis
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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
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Subjects with a history of diagnosis of immunodeficiency
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Subjects who have a close relative (within 3rd degree) of congenital immunodeficiency
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Subjects who have a history of bronchial asthma
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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)
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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)
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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
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Subjects who have a history of overseas travel within 4 weeks before the start of the clinical trial (starting from vaccination day)
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Osaka City University Hospital | Osaka | Japan |
Sponsors and Collaborators
- AnGes, Inc.
- Japan Agency for Medical Research and Development
Investigators
- Study Director: AnGes, Inc. Clinical Development, AnGes, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AG0301-COVID19-JN-01