Safety and Immunogenicity of EXG-5003

Overview

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.

Full Title of Study: “Safety and Immunogenicity of Intradermal SARS-CoV-2 Vaccine EXG-5003 in Healthy Adults”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 31, 2022

Interventions

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

Arms, Groups and Cohorts

  • Experimental: EXG-5003
  • Placebo Comparator: Placebo

Clinical Trial Outcome Measures

Primary Measures

  • Number of Participants Reporting Local and Systemic Adverse Events
    • Time Frame: Day 1 up to Day 365 post dose

Secondary Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 55 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Fujita Health University
  • Collaborator
    • Elixirgen Therapeutics, Inc.
  • Provider of Information About this Clinical Study
    • Principal Investigator: Yohei Doi, Professor and Chair of the Department of Microbiology – Fujita Health University
  • Overall Official(s)
    • Yohei Doi, MD, Principal Investigator, Fujita Health University Hospital

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