Clinical trial NCT04863131: Safety and Immunogenicity of EXG-5003
Official title: Safety and Immunogenicity of Intradermal SARS-CoV-2 Vaccine EXG-5003 in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: COVID-19
Lead sponsor: Fujita Health University
Sponsor class: OTHER
Collaborators: name: Elixirgen Therapeutics, Inc.
First posted: 2021-04-28
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants Reporting Local and Systemic Adverse Events
timeFrame: Day 1 up to Day 365 post dose
Secondary outcomes:
measure: 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.
timeFrame: Day15, Day29, Day43, Day57, Day92, Day183, Day365
measure: Assessment of T cells by Intracellular cytokine staining assays
timeFrame: Day15, Day29, Day57,
measure: Genometric Mean Titer (GMT) of serum anti-RBD IgG
timeFrame: Day15, Day29, Day43, Day57, Day92, Day183, Day365
measure: GMT of neutralizing antibody
timeFrame: Day15, Day29, Day43, Day57, Day92, Day183, Day365
Other outcomes:
Locations:
city: Toyoake
country: Japan
facility: Fujita Health University Hospital
state: Aichi
Study officials:
affiliation: Fujita Health University Hospital
name: Yohei Doi, MD
role: PRINCIPAL_INVESTIGATOR
References: