Study of COVID-19 DNA Vaccine (AG0302-COVID19)
Primary Purpose
COVID-19
Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
AG0302-COVID19
AG0302-COVID19
AG0302-COVID19
Sponsored by
About this trial
This is an interventional prevention trial for COVID-19 focused on measuring vaccine, COVID-19, SARS-CoV-2
Eligibility 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)
- 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 a current or history of serious renal, cardiovascular, respiratory, liver, kidney, gastrointestinal, and neuropsychiatric diseases
- 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 current 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 the first 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 before 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
Sites / Locations
- Osaka University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Group A
Group B
Group C
Arm Description
Outcomes
Primary Outcome Measures
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
Immunogenicity
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
Change in GMT of anti-SARS-CoV-2 Spike (S) glycoprotein receptor binding domain-specific antibody
Change in GMT of anti-SARS-CoV-2 B cell epitope antibody
Change in IgG subclasses (IgG1 and IgG2) of anti-SARS-CoV-2 spike (S) glycoprotein-specific antibody
Change in the neutralizing activity against pseudovirus of SARS-CoV-2
Change in binding inhibition of SARS-CoV-2 spike (S) glycoprotein and ACE2
Change in IFN-γ production against SARS-CoV-2 spike (S) glycoprotein by T cells in peripheral blood mononuclear cells
Adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04527081
Brief Title
Study of COVID-19 DNA Vaccine (AG0302-COVID19)
Official Title
A Randomized, Open-label, Non-controlled Phase I/II Study to Assess Safety and Immunogenicity of Twice or Three Times Dosing of Intramuscular AG0302-COVID19 (2mg) in Healthy Adults
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
August 31, 2020 (Actual)
Primary Completion Date
November 9, 2020 (Actual)
Study Completion Date
September 24, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AnGes, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will assess the safety and immunogenicity of AG0302-COVID19 in healthy adult volunteers.
Detailed Description
This is a Phase 1/2, single-center, randomized, open-label, non-controlled trial. Approximately 30 healthy volunteers, male or female, aged 20-65, will be randomized to one of the following three groups.
Group A: Vaccination twice at 2-week intervals (n = 10) Group B: Vaccination twice at 4-week intervals (n = 10) Group C: Vaccination 3 times at 2-week intervals (n = 10)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
vaccine, COVID-19, SARS-CoV-2
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Title
Group B
Arm Type
Experimental
Arm Title
Group C
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
AG0302-COVID19
Intervention Description
2.0 mg of AG0302-COVID19 twice at 2-week intervals
Intervention Type
Biological
Intervention Name(s)
AG0302-COVID19
Intervention Description
2.0 mg of AG0302-COVID19 twice at 4-week intervals
Intervention Type
Biological
Intervention Name(s)
AG0302-COVID19
Intervention Description
2.0 mg of AG0302-COVID19 three times at 2-week intervals
Primary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Description
Frequency and severity of each adverse event, solicited local and systemic AEs 8 weeks after first vaccination
Time Frame
Week 1 through Week 9
Title
Immunogenicity
Description
Change in Geometric mean titer (GMT) of serum anti-SARS-CoV-2 Spike (S) glycoprotein-specific antibody
Time Frame
Weeks 3, 5, 7, 9
Secondary Outcome Measure Information:
Title
Change in GMT of anti-SARS-CoV-2 Spike (S) glycoprotein-specific antibody
Time Frame
Weeks 13, 25, 53
Title
Change in GMT of anti-SARS-CoV-2 Spike (S) glycoprotein receptor binding domain-specific antibody
Time Frame
Weeks 3, 5, 7, 9, 13, 25, 53
Title
Change in GMT of anti-SARS-CoV-2 B cell epitope antibody
Time Frame
Week 9
Title
Change in IgG subclasses (IgG1 and IgG2) of anti-SARS-CoV-2 spike (S) glycoprotein-specific antibody
Time Frame
Weeks 3, 5, 7, 9, 13, 25, 53
Title
Change in the neutralizing activity against pseudovirus of SARS-CoV-2
Time Frame
Weeks 3, 5, 7, 9, 13, 25, 53
Title
Change in binding inhibition of SARS-CoV-2 spike (S) glycoprotein and ACE2
Time Frame
Weeks 3, 5, 7, 9, 13, 25, 53
Title
Change in IFN-γ production against SARS-CoV-2 spike (S) glycoprotein by T cells in peripheral blood mononuclear cells
Time Frame
Weeks 3, 5, 7, 9, 13, 25, 53
Title
Adverse events
Time Frame
Week 9 through Week 53
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
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 a current or history of serious renal, cardiovascular, respiratory, liver, kidney, gastrointestinal, and neuropsychiatric diseases
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 current 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 the first 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 before 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AnGes, Inc. Clinical Development
Organizational Affiliation
AnGes, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Osaka University Hospital
City
Osaka
Country
Japan
12. IPD Sharing Statement
Plan to Share IPD
No
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Study of COVID-19 DNA Vaccine (AG0302-COVID19)
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