This study will assess the safety and immunogenicity of AG0301-COVID19 in healthy adult volunteers.
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)
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
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
Osaka City University Hospital
Osaka, Japan
AnGes, Inc. Clinical Development, Study Director
AnGes, Inc.