NCT05743335

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

A PHASE 1 STUDY to ASSESS the SAFETY and IMMUNOGENICITY of a BROADLY PROTECTIVE MRNA VACCINE JCXH-221 AGAINST SARS-CoV-2 INFECTION and DISEASES

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 73 (actual)
• Sponsor: Immorna Biotherapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is a phase 1 study looking to enroll a total of 72 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.

Conditions

• COVID-19
• Infectious Disease

Interventions

Type	Name	Description
BIOLOGICAL	JCXH-221	Participants will be randomized to either placebo or JCXH-221 for Phase 1. For Phase 2, participants will either be randomized to JCXH-221 or a FDA approved Active comparator.
OTHER	Placebo	Participants will be randomized in Phase 1 to either JCXH-221 or placebo

Timeline

• Start date: 2023-03-07
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2023-02-24
• Last updated: 2024-09-19

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study