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

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

This study will assess the safety and immunogenicity of AG0301-COVID19 in healthy adult volunteers.

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Biological: AG0301-COVID19; Biological: AG0301-COVID19

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
• Enrollment (Actual): 30
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Japan
  • Osaka, Japan
    • Osaka City University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low-dose group	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
Experimental: High-dose group	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Week 1 through Week 9
Immunogenicity	Change in Geometric mean titer (GMT) of serum anti-SARS-CoV-2 spike (S) glycoprotein-specific antibody	Weeks 3, 5, 7, 9

Secondary Outcome Measures

Outcome Measure	Time Frame
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 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
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 B cell epitope antibody	Weeks 3, 5, 7, 9, 13, 25, 53

Collaborators and Investigators

• Sponsor: AnGes, Inc.
• Collaborators: Japan Agency for Medical Research and Development
• Investigators: Study Director: AnGes, Inc. Clinical Development, AnGes, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2020
• Primary Completion (Actual): September 28, 2020
• Study Completion (Actual): August 12, 2021

Study Registration Dates

• First Submitted: July 8, 2020
• First Submitted That Met QC Criteria: July 8, 2020
• First Posted (Actual): July 9, 2020

Study Record Updates

• Last Update Posted (Actual): August 18, 2021
• Last Update Submitted That Met QC Criteria: August 17, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: SARS-CoV-2; vaccine; COVID-19
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: AG0301-COVID19-JN-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No