Phase I / II study of intracutaneous inoculation of COVID-19 DNA vaccine (AG0302-COVID19)

JRCT ID: jRCT2051200085

Registered date:12/11/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: COVID-19
• Date of first enrollment: 19/11/2020
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Inoculate AG0302-COVID19 intracutaneously

Outcome(s)

Primary Outcome

1. Safety
Information such as the type, frequency and severity of adverse events that occurred from the time of the first inoculation of the investigational drug to 8 weeks after the first inoculation will be collected to evaluate the safety.
2. Immunogenicity
Rate of change from baseline in SARS-CoV-2 spike (S) glycoprotein-specific antibody titers 2 weeks after the first inoculation of the investigational drug (immediately before the second inoculation), 4 weeks, 6 weeks, and 8 weeks Analyze and assess immunogenicity.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 75age old
• Gender: Both

Include 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 75 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

Exclude 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) History of participation (history of inoculation) for the unapproved vaccine clinical trials
(4) Subjects with axillary temperature of 37.0 degree or higher
(5) Subjects who have a history of anaphylaxis due to the food or the drugs etc.
(6) Medical history of serious cardiovascular system, haemal system, respiratory system, liver, kidney, digestive system and neuropsychiatric system, or subjects who 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 degree 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 (however, 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 weeks 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

Related Information

• Primary Sponsor: RAKUGI Hiromi
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development