Safety and Immunogenicity of EXG-5003.

JRCT ID: jRCT2041210013

Registered date:23/04/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Prevention for SARS-CoV-2 infection disease
• Date of first enrollment: 20/05/2021
• Target sample size: 60
• Study type: Interventional
• Intervention(s): Injection of EXG-5003 or placebo

Outcome(s)

Primary Outcome

Humoral immune response
-Anti-RBD antibody titers
-Neutralizing antibody titers methods
Cellular immune response
-FluoroSpot Assay
- Intracellular cytokine staining assay

Secondary Outcome

Adverse events and side effects (local and systemic)
Laboratory values (hematology and chemistry)
Blood pressure, pulse
Body temperature
Weight
Electrocardiogram

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 55age old
• Gender: Both

Include criteria

-Has provided written consent for participation
-Age between 20 and 55
-Has a negative nucleic acid-based test result for SARS-CoV-2
-Has a negative antibody test result for SARS-CoV-2

Exclude criteria

-Presence of uncontrolled cardiovascular, hemetologic, respiratory, hepatic, renal, gastrointestinal, or neuropsychiatric disease
-Presence of diabetes mellitus
-Presence of active autoimmune disease
-Positive for HBc, HCV or HIV antibody
-History of anaphylactic shock
-History of epilepsy
-Presence of active malignancy
-Presence of lung disase (e.g., COPD, asthma)
-Positive urine pregnancy test within 24 hours
-Pregnant or lactatingPlanned pregnancy of self (if female) or partner (if male) within 90 days after administration of the trial drug
-If female and premenopausal, not agreeable to contraception for 90 days after second administration of the trial drug
-If male, not agreeable to contraception for 90 days after second administration of the trial drug
-Prsence of clinically relevant electrocardiogram or vital sign abnormality at screening
-Participated in a clinical trial of a drug or a medical device within 30 days or a biologic within 90 days
-Rreceived any SARS-CoV-2 vaccine
-Received within 90 days, or is planning to receive during the study period, an immunoglobulin or blood product
-Received within 180 days, or is planning to receive during the study period, a biologic product with immunosuppressive properties
-Received for 14 days or more within 180 days, or is planning to receive during the study period, a corticosteroid
-Deemed ineligible for the study as determined by the principal investigator or a co-investigator

Related Information

• Primary Sponsor: Doi Yohei
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development
• Secondary ID(s): NCT04863131