Study of COVID-19 DNA Vaccine (AG0302-COVID19)

• ClinicalTrials.gov Identifier: NCT04527081
• Recruitment Status: Completed
• First Posted: August 26, 2020
• Last Update Posted: October 4, 2021
• Sponsor: AnGes, Inc.
• Information provided by (Responsible Party): AnGes, Inc.

Tracking Information

• First Submitted Date: August 24, 2020
• First Posted Date: August 26, 2020
• Last Update Posted Date: October 4, 2021
• Actual Study Start Date: August 31, 2020
• Actual Primary Completion Date: November 9, 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: August 24, 2020)

• 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 each 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

Current Secondary Outcome Measures (submitted: August 28, 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: Week 9 ]
• 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 ]
• Change in the neutralizing activity against pseudovirus of SARS-CoV-2 [ Time Frame: Weeks 3, 5, 7, 9, 13, 25, 53 ]
• Change in binding inhibition of SARS-CoV-2 spike (S) glycoprotein and ACE2 [ Time Frame: Weeks 3, 5, 7, 9, 13, 25, 53 ]
• 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 ]
• Adverse events [ Time Frame: Week 9 through Week 53 ]

Original Secondary Outcome Measures (submitted: August 24, 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 ]

• 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 (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
• 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)

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

Intervention

• Biological: AG0302-COVID19
  2.0 mg of AG0302-COVID19 twice at 2-week intervals
• Biological: AG0302-COVID19
  2.0 mg of AG0302-COVID19 twice at 4-week intervals
• Biological: AG0302-COVID19
  2.0 mg of AG0302-COVID19 three times at 2-week intervals

Study Arms

• Experimental: Group A
  Intervention: Biological: AG0302-COVID19
• Experimental: Group B
  Intervention: Biological: AG0302-COVID19
• Experimental: Group C
  Intervention: Biological: AG0302-COVID19

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 24, 2020): 30
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: September 24, 2021
• Actual Primary Completion Date: November 9, 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 a current or history of serious renal, cardiovascular, respiratory, liver, kidney, gastrointestinal, and neuropsychiatric diseases
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 current 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 the first 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 before 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: NCT04527081
• Other Study ID Numbers: AG0302-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: Not Provided

Investigators

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

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