Overview
This study will assess the safety and immunogenicity of AG0301-COVID19 in healthy adult volunteers.
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)
Eligibility
Inclusion Criteria:
- Subjects who have obtained written consent voluntarily to participate in this clinical trial
- Subjects whose age at the time of obtaining consent is 20 years to 65 years
- Subjects who are negative for SARS-CoV-2 by PCR test
- Subjects who are negative for both SARS-CoV-2 IgM antibody and SARS-CoV-2 IgG antibody by antibody test
Exclusion Criteria:
- Subjects with symptoms of suspected COVID-19 infection (respiratory symptoms, headache, malaise, olfactory disorders, taste disorders, etc.)
- Subjects with a history of COVID-19 (hearing from subjects)
- Subjects who have participated in unapproved vaccine clinical trials
- Subjects with axillary temperature of 37.0 degree or higher
- Subjects who have a history of anaphylaxis
- Subjects who have serious renal, liquid, respiratory, liver, kidney, digestive, and neuropsychiatric history has a current medical history
- Subjects with a history of convulsion or epilepsy
- Subjects with a history of diagnosis of immunodeficiency
- Subjects who have a close relative (within 3rd degree) of congenital immunodeficiency
- Subjects who have a history of bronchial asthma
- Subjects who had a fever of 39.0C or higher within 2 days after the last vaccination, and those who suspected allergy such as a systemic rash
- 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
- 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)
- 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)
- 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
- 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
- Subjects who have a history of overseas travel within 4 weeks before the start of the clinical trial (starting from vaccination day)
- Subjects who are unable to comply with the clinical trial protocol and follow up (for mental, family, social or geographical reasons)
- Subjects who are judged to be ineligible for this clinical trial by the investigator