Safety and Immunogenicity of EXG-5003.

Phase 1

• Conditions: Prevention for SARS-CoV-2 infection disease

• Registration Number: JPRN-jRCT2041210013
• Lead Sponsor: Doi Yohei

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-04-23
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Humoral immune response<br> -Anti-RBD antibody titers<br> -Neutralizing antibody titers methods<br>Cellular immune response<br> -FluoroSpot Assay<br> - Intracellular cytokine staining assay

Secondary Outcome Measures

Name	Time	Method
Adverse events and side effects (local and systemic)<br>Laboratory values (hematology and chemistry) <br>Blood pressure, pulse <br>Body temperature <br>Weight <br>Electrocardiogram