Safety and Immunogenicity of EXG-5003

January 24, 2023 updated by: Yohei Doi, Fujita Health University

Safety and Immunogenicity of Intradermal SARS-CoV-2 Vaccine EXG-5003 in Healthy Adults

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Aichi
      • Toyoake, Aichi, Japan
        • Fujita Health University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Biological: Placebo
placebo solution
Experimental: EXG-5003
Biological: EXG-5003
COVID-19 self-replicating mRNA vaccine

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Day15, Day29, Day43, Day57, Day92, Day183, Day365
Assessment of T cells by Intracellular cytokine staining assays
Time Frame: Day15, Day29, Day57,
Day15, Day29, Day57,
Genometric Mean Titer (GMT) of serum anti-RBD IgG
Time Frame: Day15, Day29, Day43, Day57, Day92, Day183, Day365
Day15, Day29, Day43, Day57, Day92, Day183, Day365
GMT of neutralizing antibody
Time Frame: Day15, Day29, Day43, Day57, Day92, Day183, Day365
Day15, Day29, Day43, Day57, Day92, Day183, Day365

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fujita Health University

Collaborators

Elixirgen Therapeutics, Inc.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 28, 2021

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

January 24, 2023

Study Registration Dates

First Submitted

April 15, 2021

First Submitted That Met QC Criteria

April 23, 2021

First Posted (Actual)

April 28, 2021

Study Record Updates

Last Update Posted (Estimate)

January 26, 2023

Last Update Submitted That Met QC Criteria

January 24, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • EXG-5003-J01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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