Safety and Immunogenicity of EXG-5003

• ClinicalTrials.gov Identifier: NCT04863131
• Recruitment Status: Completed
• First Posted: April 28, 2021
• Last Update Posted: January 26, 2023
• Sponsor: Fujita Health University
• Collaborator: Elixirgen Therapeutics, Inc.
• Information provided by (Responsible Party): Yohei Doi, Fujita Health University

Tracking Information

• First Submitted Date: April 15, 2021
• First Posted Date: April 28, 2021
• Last Update Posted Date: January 26, 2023
• Actual Study Start Date: April 28, 2021
• Actual Primary Completion Date: December 31, 2022 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: April 23, 2021): Number of Participants Reporting Local and Systemic Adverse Events [ Time Frame: Day 1 up to Day 365 post dose ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 23, 2021)

• Flowcytometry assay to enumerate the frequency of T cells expressing CD3, CD4, CD8, CD62L, CD45RA, IFN-γ, IL-4, CD107, TNF, IL-2, IL-6, CD154 (CD40L), Perforin, and Granzyme B. [ Time Frame: Day15, Day29, Day43, Day57, Day92, Day183, Day365 ]
• Assessment of T cells by Intracellular cytokine staining assays [ Time Frame: Day15, Day29, Day57, ]
• Genometric Mean Titer (GMT) of serum anti-RBD IgG [ Time Frame: Day15, Day29, Day43, Day57, Day92, Day183, Day365 ]
• GMT of neutralizing antibody [ Time Frame: Day15, Day29, Day43, Day57, Day92, Day183, Day365 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Safety and Immunogenicity of EXG-5003
• Official Title: Safety and Immunogenicity of Intradermal SARS-CoV-2 Vaccine EXG-5003 in Healthy Adults
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1; Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Prevention
• Condition: COVID-19

Intervention

• Biological: EXG-5003
  COVID-19 self-replicating mRNA vaccine
• Biological: Placebo
  placebo solution

Study Arms

• Experimental: EXG-5003
  Intervention: Biological: EXG-5003
• Placebo Comparator: Placebo
  Intervention: Biological: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 24, 2023): 40
• Original Estimated Enrollment (submitted: April 23, 2021): 60
• Actual Study Completion Date: January 24, 2023
• Actual Primary Completion Date: December 31, 2022 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 20 Years to 55 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Japan

Administrative Information

• NCT Number: NCT04863131
• Other Study ID Numbers: EXG-5003-J01
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Yohei Doi, Fujita Health University
• Original Responsible Party: Same as current
• Current Study Sponsor: Fujita Health University
• Original Study Sponsor: Same as current
• Collaborators: Elixirgen Therapeutics, Inc.

Investigators

• Principal Investigator: Yohei Doi, MD; Fujita Health University Hospital

• PRS Account: Fujita Health University
• Verification Date: January 2023