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CompletedNCT04863131Updated Jan 26, 2023

Safety and Immunogenicity of EXG-5003

A Phase 1/2 interventional study of EXG-5003 and Placebo in COVID-19, sponsored by Fujita Health University. Completed at 1 site in Japan. Open to participants aged 20 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-01-26.

Sponsored by Fujita Health University · Phase 1/2, Interventional, and Prevention

Phase
Phase 1/2
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
20 Years to 55 Years
Sex
All
01

Study 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.

02

Conditions studied

  • COVID-19
03

In context

Lead sponsor

Fujita Health University is the lead sponsor of 6 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    EXG-5003

    Biological: EXG-5003

  • Placebo comparator
    Placebo

    Biological: Placebo

Interventions

  • BiologicalEXG-5003

    COVID-19 self-replicating mRNA vaccine

  • BiologicalPlacebo

    placebo solution

06

What researchers measure

Primary outcomes

  1. Number of Participants Reporting Local and Systemic Adverse Events

    Time frame: Day 1 up to Day 365 post dose

Secondary outcomes

  1. 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

  2. Assessment of T cells by Intracellular cytokine staining assays

    Time frame: Day15, Day29, Day57,

  3. Genometric Mean Titer (GMT) of serum anti-RBD IgG

    Time frame: Day15, Day29, Day43, Day57, Day92, Day183, Day365

  4. GMT of neutralizing antibody

    Time frame: Day15, Day29, Day43, Day57, Day92, Day183, Day365

07

Study locations

1 site
  • Fujita Health University Hospital
    Toyoake, Aichi, Japan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 26, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04863131
Lead sponsor
Fujita Health University
Collaborators
Elixirgen Therapeutics, Inc.
Responsible party
Yohei Doi (Professor and Chair of the Department of Microbiology, Fujita Health University) — Principal investigator
First posted
Apr 28, 2021
Start date
Apr 28, 2021
Primary completion
Dec 31, 2022
Completion
Jan 24, 2023
Last update
Jan 26, 2023

Study contacts

Yohei Doi, MD
principal investigator · Fujita Health University Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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