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Safety and Immunogenicity of EXG-5003

Sponsor
Fujita Health University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04863131
Collaborator
Elixirgen Therapeutics, Inc. (Industry)
60
Enrollment
1
Location
2
Arms
21.1
Anticipated Duration (Months)
2.8
Patients Per Site Per Month

Study Details

Study Description

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
  • Biological: EXG-5003
  • Biological: Placebo
 Phase 1/Phase 2

Study Design

Study Type:
Interventional
Anticipated 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 :
Apr 28, 2021
Anticipated Primary Completion Date :
Jan 31, 2023
Anticipated Study Completion Date :
Jan 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: EXG-5003

Biological: EXG-5003
COVID-19 self-replicating mRNA vaccine
Placebo Comparator: Placebo

Biological: Placebo
placebo solution

Outcome Measures

Primary Outcome Measures

  1. Number of Participants Reporting Local and Systemic Adverse Events [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. [Day15, Day29, Day43, Day57, Day92, Day183, Day365]

  2. Assessment of T cells by Intracellular cytokine staining assays [Day15, Day29, Day57,]

  3. Genometric Mean Titer (GMT) of serum anti-RBD IgG [Day15, Day29, Day43, Day57, Day92, Day183, Day365]

  4. GMT of neutralizing antibody [Day15, Day29, Day43, Day57, Day92, Day183, Day365]

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 55 Years
Sexes Eligible for Study:
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:

  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Fujita Health University Hospital Toyoake Aichi Japan

Sponsors and Collaborators

  • Fujita Health University
  • Elixirgen Therapeutics, Inc.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
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:
Apr 28, 2021
Last Update Posted:
Apr 30, 2021
Last Verified:
Apr 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Apr 30, 2021