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

NCT05743335 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 73

Last updated 2024-09-19

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • ICON plc

    collaborator INDUSTRY

  • Immorna Biotherapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-07
Primary Completion
2023-12-01
Completion
2023-12-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT05743335 on ClinicalTrials.gov