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Safety and Immunogenicity of EXG-5003

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04863131
Recruitment Status : Recruiting
First Posted : April 28, 2021
Last Update Posted : April 30, 2021
Sponsor:
Collaborator:
Elixirgen Therapeutics, Inc.
Information provided by (Responsible Party):
Yohei Doi, Fujita Health University

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.

Condition or disease Intervention/treatment Phase
COVID-19 Biological: EXG-5003 Biological: Placebo Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Safety and Immunogenicity of Intradermal SARS-CoV-2 Vaccine EXG-5003 in Healthy Adults
Actual Study Start Date : April 28, 2021
Estimated Primary Completion Date : January 31, 2023
Estimated Study Completion Date : January 31, 2023

Arm Intervention/treatment
Experimental: EXG-5003 Biological: EXG-5003
COVID-19 self-replicating mRNA vaccine

Placebo Comparator: Placebo Biological: Placebo
placebo solution




Primary Outcome Measures :
  1. Number of Participants Reporting Local and Systemic Adverse Events [ Time Frame: Day 1 up to Day 365 post dose ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04863131


Contacts
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Contact: Koga 202-615-6004 mkoga@kmphc.com

Locations
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Japan
Fujita Health University Hospital Recruiting
Toyoake, Aichi, Japan
Contact: Yohei Doi, MD         
Sponsors and Collaborators
Fujita Health University
Elixirgen Therapeutics, Inc.
Investigators
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Principal Investigator: Yohei Doi, MD Fujita Health University Hospital
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Responsible Party: Yohei Doi, Professor and Chair of the Department of Microbiology, Fujita Health University
ClinicalTrials.gov Identifier: NCT04863131    
Other Study ID Numbers: EXG-5003-J01
First Posted: April 28, 2021    Key Record Dates
Last Update Posted: April 30, 2021
Last Verified: April 2021

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