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A Phase 1/2 Study to Assess the Safety and Immunogenicity of JCXH-221, an mRNA-based Broadly Protective COVID-19 Vaccine

COVID-19 Clinical Trial

Official title:
A PHASE 1/2 STUDY TO ASSESS THE SAFETY AND IMMUNOGENICITY OF A BROADLY PROTECTIVE mRNA VACCINE JCXH-221 AGAINST SARS-CoV-2 INFECTION AND DISEASES

Clinical Trial Summary

The goal of this clinical trial is to learn about, test, and compare JCXH-221 in healthy volunteers. The main aims to answer are: - To assess the safety and tolerability of the JCXH-221 vaccine in healthy adult subjects - To identify an optimal dose for the JCXH-221 vaccine in healthy adult subjects - To assess the humoral immunogenicity of the JCXH-221 vaccine in healthy adult subjects - To characterize the cellular immunogenicity of the JCXH-221 vaccine in healthy adult subjects Participants for Phase I will be randomized to either JCXH-221 or placebo. In Phase 2, participants will be randomized to either JCXH-221 or a FDA approved Active comparator.

Clinical Trial Description

This is a phase 1/2 study looking to enroll a total of 262 patients. For phase 1, two cohorts will be explored (18-64 age group and 65+ age group) for a total of 72 subjects. The subjects will be enrolled and randomized to either placebo or JCXH-221. A low dose of JCXH-221 will be explored vs placebo for each age group first. A high dose for those 2 cohorts will be explored once all safety data is reviewed. Once all of Phase 1 data has been reviewed, Phase 2 enrollment will open. In this portion of the trial, subjects will be enrolled and randomized to either JCXH-221 or a FDA approved Active comparator (Pfizer, Moderna, etc.). A total of 190 patients will be enrolled. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05743335
Study type Interventional
Source Immorna Biotherapeutics, Inc.
Contact Banji Oduola
Phone 630-687-3084
Email banji.oduola@immornabio.com
Status Recruiting
Phase Phase 1/Phase 2
Start date March 20, 2023
Completion date October 4, 2024
View Details
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