Safety and Immunogenicity of EXG-5003

NCT04863131 | Completed Phase 1 DMC

• 1 other identifier: EXG-5003-J01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• Number of Participants Reporting Local and Systemic Adverse Events

  Day 1 up to Day 365 post dose

Secondary Outcomes (4)

• 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

• Assessment of T cells by Intracellular cytokine staining assays

  Day15, Day29, Day57,

• Genometric Mean Titer (GMT) of serum anti-RBD IgG

  Day15, Day29, Day43, Day57, Day92, Day183, Day365

• GMT of neutralizing antibody

  Day15, Day29, Day43, Day57, Day92, Day183, Day365

Study Arms (2)

EXG-5003

EXPERIMENTAL

Biological: EXG-5003

Placebo

PLACEBO COMPARATOR

Biological: Placebo

Interventions

EXG-5003 BIOLOGICAL

COVID-19 self-replicating mRNA vaccine

EXG-5003

Placebo BIOLOGICAL

placebo solution

Placebo

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fujita Health University: lead
• Elixirgen Therapeutics, Inc.: collaborator

Study Sites (1)

Fujita Health University Hospital

Toyoake, Aichi-ken, Japan

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Yohei Doi, MD

  Fujita Health University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chair of the Department of Microbiology

Study Record Dates

• First Submitted: April 15, 2021
• First Posted: April 28, 2021
• Study Start: April 28, 2021
• Primary Completion: December 31, 2022
• Study Completion: January 24, 2023
• Last Updated: January 26, 2023

Record last verified: 2023-01

Locations

JP (1)