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

NCT ID: NCT04463472

Last Updated: 2021-08-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-29
• Study Completion Date: 2021-08-12

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)

Conditions

COVID-19

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Low-dose group

Group Type: EXPERIMENTAL

AG0301-COVID19

Intervention Type: BIOLOGICAL

1.0 mg of AG0301-COVID19 twice at 2-week intervals

High-dose group

Group Type: EXPERIMENTAL

AG0301-COVID19

Intervention Type: BIOLOGICAL

2.0 mg of AG0301-COVID19 twice at 2-week intervals

Interventions

AG0301-COVID19

1.0 mg of AG0301-COVID19 twice at 2-week intervals

Intervention Type: BIOLOGICAL

AG0301-COVID19

2.0 mg of AG0301-COVID19 twice at 2-week intervals

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Japan Agency for Medical Research and Development

OTHER_GOV

Sponsor Role: collaborator

AnGes, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

AnGes, Inc. Clinical Development

Role: STUDY_DIRECTOR

AnGes, Inc.

Locations

Osaka City University Hospital

Osaka, , Japan

Countries

Japan

Other Identifiers

AG0301-COVID19-JN-01

Identifier Type: -

Identifier Source: org_study_id