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Safety and Immunogenicity of EXG-5003.
JPRN; 23/04/2021; TrialID: JPRN-jRCT2041210013
Clinical Trial Register | ICTRP | ID: ictrp-JPRN-jRCT2041210013
ABSTRACT

Condition

Prevention for SARS-CoV-2 infection disease

Intervention

Injection of EXG-5003 or placebo

Primary 

outcome:

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

Criteria

Inclusion 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

Exclusion 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
Collection: Clinical trial registers Database: ICTRP Topics: Vaccines Year: 2021 Document Type: Clinical Trial Register

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Collection: Clinical trial registers Database: ICTRP Topics: Vaccines Year: 2021 Document Type: Clinical Trial Register