Safety and Immunogenicity of EXG-5003

NCT ID: NCT04863131

Last Updated: 2023-01-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-28
• Study Completion Date: 2023-01-24

Brief Summary

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.

Conditions

COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

EXG-5003

Group Type: EXPERIMENTAL

EXG-5003

Intervention Type: BIOLOGICAL

COVID-19 self-replicating mRNA vaccine

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

placebo solution

Interventions

EXG-5003

COVID-19 self-replicating mRNA vaccine

Intervention Type: BIOLOGICAL

Placebo

placebo solution

Intervention Type: BIOLOGICAL

Eligibility 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

• 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Elixirgen Therapeutics, Inc.

INDUSTRY

Sponsor Role: collaborator

Fujita Health University

OTHER

Sponsor Role: lead

Responsible Party

Yohei Doi

Professor and Chair of the Department of Microbiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yohei Doi, MD

Role: PRINCIPAL_INVESTIGATOR

Fujita Health University Hospital

Locations

Fujita Health University Hospital

Toyoake, Aichi-ken, Japan

Countries

Japan

Other Identifiers

EXG-5003-J01

Identifier Type: -

Identifier Source: org_study_id