Ignite Creation Date:
2025-12-24 @ 10:32 PM
Ignite Modification Date:
2025-12-28 @ 11:02 AM
Study NCT ID:
NCT05743335
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2023-02-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 1 Study to Assess the Safety and Immunogenicity of JCXH-221, an MRNA-based Broadly Protective COVID-19 Vaccine
Sponsor:
Immorna Biotherapeutics, Inc.
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
* 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: