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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

Tracking Information
First Submitted Date  ICMJE April 15, 2021
First Posted Date  ICMJE April 28, 2021
Last Update Posted Date April 30, 2021
Actual Study Start Date  ICMJE April 28, 2021
Estimated Primary Completion Date January 31, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 23, 2021)
Number of Participants Reporting Local and Systemic Adverse Events [ Time Frame: Day 1 up to Day 365 post dose ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 23, 2021)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Immunogenicity of EXG-5003
Official Title  ICMJE Safety and Immunogenicity of Intradermal SARS-CoV-2 Vaccine EXG-5003 in Healthy Adults
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE COVID-19
Intervention  ICMJE
  • Biological: EXG-5003
    COVID-19 self-replicating mRNA vaccine
  • Biological: Placebo
    placebo solution
Study Arms  ICMJE
  • Experimental: EXG-5003
    Intervention: Biological: EXG-5003
  • Placebo Comparator: Placebo
    Intervention: Biological: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 23, 2021)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 31, 2023
Estimated Primary Completion Date January 31, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Koga 202-615-6004 mkoga@kmphc.com
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04863131
Other Study ID Numbers  ICMJE EXG-5003-J01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yohei Doi, Fujita Health University
Study Sponsor  ICMJE Fujita Health University
Collaborators  ICMJE Elixirgen Therapeutics, Inc.
Investigators  ICMJE
Principal Investigator: Yohei Doi, MD Fujita Health University Hospital
PRS Account Fujita Health University
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP