Safety and Immunogenicity of EXG-5003

Phase 1

Completed

• Conditions: COVID-19
• Interventions: Biological: Placebo; Biological: EXG-5003

• Registration Number: NCT04863131
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-15
• Study First Submitted QC: 2021-04-23
• Study Start: 2021-04-28
• Study First Posted: 2021-04-28
• Primary Completion: 2022-12-31
• Status Verified: 2023-01
• Study Completion: 2023-01-24
• Last Update Submitted: 2023-01-24
• Last Update Posted: 2023-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
EXG-5003	EXG-5003	-

Primary Outcome Measures

Name	Time	Method
Number of Participants Reporting Local and Systemic Adverse Events	Day 1 up to Day 365 post dose

Secondary Outcome Measures

Name	Time	Method
GMT of neutralizing antibody	Day15, Day29, Day43, Day57, Day92, Day183, Day365
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

Trial Locations

Locations (1)

Fujita Health University Hospital; 🇯🇵 Toyoake, Aichi, Japan