This study will assess the safety and immunogenicity of AG0302-COVID19 in healthy volunteers.
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)
Biological: AG0302-COVID19 for Intramuscular Injection
Vaccination 2 mg of AG0302-COVID19 three times at 2-week intervals
Biological: AG0302-COVID19 for Intramuscular Injection
Vaccination 4 mg of AG0302-COVID19 twice at 4-week intervals
Biological: AG0302-COVID19 for Intramuscular Injection
Vaccination 8 mg of AG0302-COVID19 twice at 4-week intervals
Biological: AG0302-COVID19 for Intradermal Injection
Vaccination 1 mg of AG0302-COVID19 three times at 2-week intervals
Biological: AG0302-COVID19 for Intradermal Injection
Vaccination 1 mg of AG0302-COVID19 twice at 4-week intervals
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
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
Clinical Development, Study Director
AnGes, Inc.