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

AnGes

Status and phase

Completed

Phase 2

Phase 1

Conditions

COVID-19

Treatments

Biological: AG0301-COVID19

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04463472

AG0301-COVID19-JN-01

Details and patient eligibility

About

This study will assess the safety and immunogenicity of AG0301-COVID19 in healthy adult volunteers.

Full 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)

Enrollment

30 patients

Sex

All

Ages

20 to 65 years old

Volunteers

Accepts Healthy Volunteers

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 39.0°C 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