Safety and Immunogenicity of EXG-5003

Fujita Health University

Status and phase

Completed

Phase 2

Phase 1

Conditions

COVID-19

Treatments

Biological: EXG-5003

Biological: Placebo

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04863131

EXG-5003-J01

Details and patient eligibility

About

This is a First in Human, randomized, placebo-controlled Phase I/II trial to evaluate the safety and immunogenicity of the intradermal COVID-19 vaccine, EXG-5003 in healthy adults.

Enrollment

40 patients

Sex

All

Ages

20 to 55 years old

Volunteers

Accepts Healthy Volunteers

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

Signs and symptoms consistent with COVID-19 upon screening
History of COVID-19
Presence of uncontrolled cardiovascular, hematologic, 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 disease (e.g., COPD, asthma)
Positive urine pregnancy test within 24 hours
Pregnant, lactating, planned 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
Presence 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
Received 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