Phase I/II Study of COVID-19 DNA Vaccine (AG0302-COVID19 High-dose)

NCT ID: NCT04993586

Last Updated: 2022-11-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 422 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-29
• Study Completion Date: 2022-09-23

Brief Summary

This study will assess the safety and immunogenicity of AG0302-COVID19 in healthy volunteers.

Detailed Description

This is a Phase I/II, multi-center, randomized, open-label, uncontrolled trial. Approximately 400 healthy volunteers, male or female, aged 18 years or older, will be randomized to one of the following five groups:

[IM Groups] Group A: Vaccination 2 mg, three times at 2-week intervals (n = 80) Group B: Vaccination 4 mg, twice at 4-week intervals (n = 80) Group C: Vaccination 8 mg, twice at 4-week intervals(n = 80)

[ID Groups] Group D: Vaccination 1 mg, three times at 2-week intervals (n = 80) Group E: Vaccination 1 mg, twice at 4-week intervals (n = 80)

Conditions

COVID-19 Lower Respiratory Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Group A

Group Type: EXPERIMENTAL

AG0302-COVID19 for Intramuscular Injection

Intervention Type: BIOLOGICAL

Vaccination 2 mg of AG0302-COVID19 three times at 2-week intervals

Group B

Group Type: EXPERIMENTAL

AG0302-COVID19 for Intramuscular Injection

Intervention Type: BIOLOGICAL

Vaccination 4 mg of AG0302-COVID19 twice at 4-week intervals

Group C

Group Type: EXPERIMENTAL

AG0302-COVID19 for Intramuscular Injection

Intervention Type: BIOLOGICAL

Vaccination 8 mg of AG0302-COVID19 twice at 4-week intervals

Group D

Group Type: EXPERIMENTAL

AG0302-COVID19 for Intradermal Injection

Intervention Type: BIOLOGICAL

Vaccination 1 mg of AG0302-COVID19 three times at 2-week intervals

Group E

Group Type: EXPERIMENTAL

AG0302-COVID19 for Intradermal Injection

Intervention Type: BIOLOGICAL

Vaccination 1 mg of AG0302-COVID19 twice at 4-week intervals

Interventions

AG0302-COVID19 for Intramuscular Injection

Vaccination 2 mg of AG0302-COVID19 three times at 2-week intervals

Intervention Type: BIOLOGICAL

AG0302-COVID19 for Intramuscular Injection

Vaccination 4 mg of AG0302-COVID19 twice at 4-week intervals

Intervention Type: BIOLOGICAL

AG0302-COVID19 for Intramuscular Injection

Vaccination 8 mg of AG0302-COVID19 twice at 4-week intervals

Intervention Type: BIOLOGICAL

AG0302-COVID19 for Intradermal Injection

Vaccination 1 mg of AG0302-COVID19 three times at 2-week intervals

Intervention Type: BIOLOGICAL

AG0302-COVID19 for Intradermal Injection

Vaccination 1 mg of AG0302-COVID19 twice at 4-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 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 with a history of vaccination for the prevention of COVID-19

4. Subjects who have participated in unapproved vaccine clinical trials within 1 year before the start of this study

5. Subjects with an axillary temperature of 37.5 degrees or higher at the time of screening

6. Subjects with an axillary temperature of 37.5 degrees or higher before the first vaccination

7. Subjects who have a history of anaphylaxis

8. Subjects who have a history of hypersensitivity to the ingredients of the investigational drug

9. Subjects who have a current or history of serious renal, cardiovascular, respiratory, liver, kidney, gastrointestinal, and neuropsychiatric diseases

10. Subjects with a history of convulsion or epilepsy

11. Subjects with a history of diagnosis of immunodeficiency

12. Subjects who have a close relative (within 3rd degree) of congenital immunodeficiency

13. Subjects who have current bronchial asthma

14. 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.

15. Females who wish to become pregnant from the time of obtaining consent 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

16. 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)

17. 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)

18. 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

19. 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

20. Subjects who have a history of overseas travel within 4 weeks before the start of the clinical trial (starting from vaccination day)

21. Subjects who are unable to comply with the clinical trial protocol and follow up (for mental, family, social or geographical reasons)

22. Subjects who are judged to be ineligible for this clinical trial by the investigator

• Minimum Eligible Age: 18 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

Clinical Development

Role: STUDY_DIRECTOR

AnGes, Inc.

Locations

IUHW Narita Hospital

Narita, Chiba, Japan

Medical Corporation Heishinkai OCROM Clinic

Suita, Osaka, Japan

Medical Corporation Heishinkai ToCROM Clinic

Shinjuku-ku, Tokyo, Japan

Medical Corporation Shinanokai Shinanozaka Clinic

Shinjuku-ku, Tokyo, Japan

Sekino Clinical Pharmacology Clinic

Toshima-ku, Tokyo, Japan

Medical Corporation Heishinkai OPHAC Hospital

Osaka, , Japan

Countries

Japan

Other Identifiers

AG0302-COVID19-JN-03

Identifier Type: -

Identifier Source: org_study_id