A Phase 1/2 interventional study of EXG-5003 and Placebo in COVID-19, sponsored by Fujita Health University. Completed at 1 site in Japan. Open to participants aged 20 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-01-26.
Sponsored by Fujita Health University · Phase 1/2, Interventional, and Prevention
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.
Fujita Health University is the lead sponsor of 6 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Biological: EXG-5003
Biological: Placebo
COVID-19 self-replicating mRNA vaccine
placebo solution
Number of Participants Reporting Local and Systemic Adverse Events
Time frame: Day 1 up to Day 365 post dose
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
This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Fujita Health University