Phase II / III Study of COVID-19 DNA Vaccine (AG0302-COVID19)

• ClinicalTrials.gov Identifier: NCT04655625
• Recruitment Status: Completed
• First Posted: December 7, 2020
• Last Update Posted: June 8, 2022
• Sponsor: AnGes, Inc.
• Collaborator: Japan Agency for Medical Research and Development
• Information provided by (Responsible Party): AnGes, Inc.

Tracking Information

• First Submitted Date: November 26, 2020
• First Posted Date: December 7, 2020
• Last Update Posted Date: June 8, 2022
• Actual Study Start Date: November 23, 2020
• Actual Primary Completion Date: April 2, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 4, 2020)

• Incidence of Treatment-Emergent Adverse Events [ Time Frame: Group A: 6 weeks Group B: 8 weeks ]
  Frequency and severity of each adverse event solicited local and systemic AEs from the first vaccination to 4 weeks after the second vaccination
• Immunogenicity [ Time Frame: Group A: Week 7 Group B: Week 9 ]
  Change in Geometric mean titer (GMT) of serum anti-SARS-CoV-2 Spike (S) glycoprotein-specific antibody

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: December 4, 2020)

• Change in GMT of anti-SARS-CoV-2 Spike (S) glycoprotein-specific antibody [ Time Frame: Group A: Weeks 5, 25, 53 Group B: Weeks 7, 25, 53 ]
• Change in the neutralizing activity against pseudovirus of SARS-CoV-2 [ Time Frame: Group A: Weeks 5, 7, 25, 53 Group B: Weeks 7, 9, 25, 53 ]
• Change in IFN-gamma production against SARS-CoV-2 spike (S) glycoprotein by T cells in peripheral blood mononuclear cells [ Time Frame: Group A: Weeks 5, 7, 25, 53 Group B: Weeks 7, 9, 25, 53 ]
• IgG subclasses (IgG1 and IgG2) of anti-SARS-CoV-2 spike (S) glycoprotein-specific antibody [ Time Frame: Group A: Weeks 5, 7, 25, 53 Group B: Weeks 7, 9, 25, 53 ]
• Adverse events [ Time Frame: Group A: Week 7 through Week 53 Group B: Week 9 through Week 53 ]
• Rate of SARS-CoV-2 positive and incidence rate of COVID-19 after the first vaccination [ Time Frame: Week 1 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: Phase II / III Study of COVID-19 DNA Vaccine (AG0302-COVID19)
• Official Title: A Randomized, Double-blind, Placebo Controlled Phase II / III Study to Assess Safety, Immunogenicity and Efficacy of Twice Dosing of Intramuscular AG0302-COVID19 (2mg) in Healthy Adults
• Brief Summary: This study will assess the safety, immunogenicity and efficacy of AG0302-COVID19 in healthy adult volunteers.

Detailed Description

This is a Phase II /III, multi-center, randomized, double-blind, placebo controlled trial. Approximately 500 healthy volunteers, male or female, aged 18 years or older, will be randomized to one of the following two groups:

Group A: Vaccination twice at 2-week intervals (n = 250) Group B: Vaccination twice at 4-week intervals (n = 250)

Fifty subjects in each group will receive placebos.

• Study Type: Interventional
• Study Phase: Phase 2; Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Prevention
• Condition: COVID-19

Intervention

• Biological: Group A (AG0302-COVID19)
  2 mg of AG0302-COVID19 twice at 2-week intervals
• Biological: Group A (Placebo)
  Placebo twice at 2-week intervals
• Biological: Group B (AG0302-COVID19)
  2 mg of AG0302-COVID19 twice at 4-week intervals
• Biological: Group B (Placebo)
  Placebo twice at 4-week intervals

Study Arms

• Experimental: Group A (AG-0302-COVID19)
  Intervention: Biological: Group A (AG0302-COVID19)
• Placebo Comparator: Group A (Placebo)
  Intervention: Biological: Group A (Placebo)
• Experimental: Group B (AG-0302-COVID19)
  Intervention: Biological: Group B (AG0302-COVID19)
• Placebo Comparator: Group B (Placebo)
  Intervention: Biological: Group B (Placebo)

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 4, 2020): 500
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: February 1, 2022
• Actual Primary Completion Date: April 2, 2021 (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 18 years or older
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 within 1 year before the start of this study
4. Subjects with axillary temperature of 37.0 degree or higher at the time of screening and before the first vaccination
5. Subjects who have a history of anaphylaxis
6. Subjects who have a history of hypersensitivity to the ingredients of the investigational drug
7. Subjects who have a current or history of serious renal, cardiovascular, respiratory, liver, kidney, gastrointestinal, and neuropsychiatric diseases
8. Subjects with a history of convulsion or epilepsy
9. Subjects with a history of diagnosis of immunodeficiency
10. Subjects who have a close relative (within 3rd degree) of congenital immunodeficiency
11. Subjects who have current bronchial asthma
12. Subjects who have had a fever of 39.0 degrees or higher within 2 days after vaccination, or who have been suspected of having an allergy such as a systemic rash.
13. Females who wish to become pregnant from the study registration to 12 weeks after the first vaccination, 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
14. 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)
15. 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)
16. 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
17. Subjects who received blood transfusion or gamma globulin therapy within 12 weeks before vaccination, or high-dose gamma globulin therapy (200 mg/kg or more) within 24 weeks before vaccination
18. Subjects who have a history of overseas travel within 4 weeks before the start of the clinical trial (starting from vaccination day)
19. Subjects who are unable to comply with the clinical trial protocol and follow up (for mental, family, social or geographical reasons)
20. Subjects who are judged to be ineligible for this clinical trial by the investigator

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (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: NCT04655625
• Other Study ID Numbers: AG0302-COVID19-JN-02
• 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: June 2022