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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
40
Fujita Health University Hospital
Toyoake, Aichi-ken, Japan
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 platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.