MedTrace Logo

Safety and Immunogenicity of EXG-5003

NCT04863131 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-01-26

No results posted yet for this study

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

Interventions

BIOLOGICAL

EXG-5003

COVID-19 self-replicating mRNA vaccine

BIOLOGICAL

Placebo

placebo solution

Sponsors & Collaborators

  • Elixirgen Therapeutics, Inc.

    collaborator INDUSTRY

  • Fujita Health University

    lead OTHER

Principal Investigators

  • Yohei Doi, MD · Fujita Health University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-28
Primary Completion
2022-12-31
Completion
2023-01-24

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04863131 on ClinicalTrials.gov