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

• ClinicalTrials.gov Identifier: NCT04463472
• Recruitment Status: Completed
• First Posted: July 9, 2020
• Last Update Posted: August 18, 2021
• Sponsor: AnGes, Inc.
• Collaborator: Japan Agency for Medical Research and Development
• Information provided by (Responsible Party): AnGes, Inc.

Tracking Information

• First Submitted Date: July 8, 2020
• First Posted Date: July 9, 2020
• Last Update Posted Date: August 18, 2021
• Actual Study Start Date: June 29, 2020
• Actual Primary Completion Date: September 28, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 8, 2021)

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

Original Primary Outcome Measures (submitted: July 8, 2020)

• Safety (from the first dose to 8 weeks later) [ Time Frame: Week 1 through Week 9 ]
  Frequency and severity of each adverse event, solicited local and systemic AEs 14days after each vaccination
• Immunogenicity [ Time Frame: Weeks 3, 5, 7, 9 ]
  Geometric mean titer (GMT) of serum anti-SARS-CoV-2 spike glycoprotein-specific antibody

Current Secondary Outcome Measures (submitted: July 8, 2020)

• Change in GMT of anti-SARS-CoV-2 spike (S) glycoprotein-specific antibody [ Time Frame: Weeks 13, 25, 53 ]
• 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 ]
• Change in GMT of anti-SARS-CoV-2 B cell epitope antibody [ Time Frame: 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 [ Time Frame: Weeks 3, 5, 7, 9, 13, 25, 53 ]
• Adverse events [ Time Frame: Week 9 through Week 53 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study of COVID-19 DNA Vaccine (AG0301-COVID19)
• Official Title: 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
• Brief Summary: This study will assess the safety and immunogenicity of AG0301-COVID19 in healthy adult volunteers.

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 Type: Interventional
• Study Phase: Phase 1; Phase 2
• Study Design: Allocation: Non-Randomized; Intervention Model: Sequential Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Condition: COVID-19

Intervention

• Biological: AG0301-COVID19
  1.0 mg of AG0301-COVID19 twice at 2-week intervals
• Biological: AG0301-COVID19
  2.0 mg of AG0301-COVID19 twice at 2-week intervals

Study Arms

• Experimental: Low-dose group
  Intervention: Biological: AG0301-COVID19
• Experimental: High-dose group
  Intervention: Biological: AG0301-COVID19

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 8, 2020): 30
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: August 12, 2021
• Actual Primary Completion Date: September 28, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. Subjects who have obtained written consent voluntarily to participate in this clinical trial
2. Subjects whose age at the time of obtaining consent is 20 years to 65 years
3. Subjects who are negative for SARS-CoV-2 by PCR test
4. Subjects who are negative for both SARS-CoV-2 IgM antibody and SARS-CoV-2 IgG antibody by antibody test

Exclusion Criteria:

1. Subjects with symptoms of suspected COVID-19 infection (respiratory symptoms, headache, malaise, olfactory disorders, taste disorders, etc.)
2. Subjects with a history of COVID-19 (hearing from subjects)
3. Subjects who have participated in unapproved vaccine clinical trials
4. Subjects with axillary temperature of 37.0 degree or higher
5. Subjects who have a history of anaphylaxis
6. Subjects who have serious renal, liquid, respiratory, liver, kidney, digestive, and neuropsychiatric history has a current medical history
7. Subjects with a history of convulsion or epilepsy
8. Subjects with a history of diagnosis of immunodeficiency
9. Subjects who have a close relative (within 3rd degree) of congenital immunodeficiency
10. Subjects who have a history of bronchial asthma
11. 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
12. 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
13. 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)
14. 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)
15. 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
16. 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
17. Subjects who have a history of overseas travel within 4 weeks before the start of the clinical trial (starting from vaccination day)
18. Subjects who are unable to comply with the clinical trial protocol and follow up (for mental, family, social or geographical reasons)
19. Subjects who are judged to be ineligible for this clinical trial by the investigator

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 20 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Japan

Administrative Information

• NCT Number: NCT04463472
• Other Study ID Numbers: AG0301-COVID19-JN-01
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: AnGes, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: AnGes, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Japan Agency for Medical Research and Development

Investigators

• Study Director: AnGes, Inc. Clinical Development; AnGes, Inc.

• PRS Account: AnGes, Inc.
• Verification Date: August 2021