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Completed

NCT Number: NCT04863131

Safety and Immunogenicity of EXG-5003

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.

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Key information

Age range

20 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Fujita Health University Hospital

Toyoake, Aichi-ken, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EXG-5003

Biological

COVID-19 self-replicating mRNA vaccine

Placebo

Biological

placebo solution

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

Sponsors and collaborators

Lead sponsor

Fujita Health University

Other

Collaborators

  • Elixirgen Therapeutics, Inc.

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Apr 28, 2021
Registry last updated
Jan 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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