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

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

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.

Study Overview

• Status: Recruiting
• Conditions: COVID-19; Infectious Disease
• Intervention / Treatment: Biological: JCXH-221; Other: Placebo; Biological: Active Comparator

Detailed 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 Type: Interventional
• Enrollment (Anticipated): 262
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Banji Oduola; Phone Number: 630-687-3084; Email: banji.oduola@immornabio.com
• Study Contact Backup: Name: Stephanie Allan; Email: stephanie.allan@immornabio.com

Study Locations

• United States
  • Florida
    • Hallandale Beach, Florida, United States, 33009
      • Recruiting
      • Velocity Clinical Research
  • Georgia
    • Savannah, Georgia, United States, 31406
      • Recruiting
      • Velocity Clinical Research
  • Nebraska
    • Lincoln, Nebraska, United States, 68510
      • Recruiting
      • Velocity Clinical Research
  • Texas
    • Cedar Park, Texas, United States, 78613
      • Recruiting
      • Velocity Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Main Inclusion Criteria

• Sex: Male or female; female subjects may be of childbearing potential, of nonchildbearing potential, or postmenopausal.
• Age: 18 years of age or older, at screening.
• Status: Healthy subjects.
• Subjects must have completed the full doses for primary vaccination with an approved SARS-CoV-2 vaccine and may have received booster dose(s), with the last vaccination (can be 2nd dose of primary vaccination or booster dose) having occurred at least 4 months prior to enrollment.

Main Exclusion Criteria

• Current or prior symptomatic or asymptomatic SARS-CoV-2 infection confirmed by an approved or authorized rapid antigen test on Day 1 or within 4 months prior to Day 1.
• Subjects with significant exposure (as defined by current CDC guidance) to someone with laboratory confirmed SARS-CoV-2 infection or COVID-19 with the past 14 days prior to the Screening visit.
• Subjects with fever or signs of acute infection at the time of enrollment and vaccination.
• Subjects who are taking medications that may prevent or treat COVID-19.
• Subjects who received convalescent serum or prior therapeutic antibodies against SARS-CoV-2 within 4 months before Day 1.
• Subjects with history of myocarditis or pericarditis, or with AEs after mRNA vaccination that are in nature and severity beyond the common AEs expected and necessitating medical intervention.
• Subjects with active or suspected immunosuppression, immunodeficiency, or autoimmune disease.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Investigational product; Patients randomized to this arm will be given the investigational product (JCXH-221).	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.
Placebo Comparator: Placebo; Patients randomized to this arm will be given a placebo vaccine.	Other: Placebo; Participants will be randomized in Phase 1 to either JCXH-221 or placebo
Active Comparator: Active Comparator; Patients randomized to this arm will be given an active FDA approved COVID-19 Vaccine (Pfizer, Moderna, etc.).	Biological: Active Comparator; Participants will be randomized in Phase 2 to either JCXH-221 or a FDA approved Active Comparator,

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SAE frequency	Frequency of serious adverse events (SAEs) characterized by type, severity, duration, and drug relationship, from Day 1 (dosing day) until follow-up completion	Day 1- Day 365 (12 months)
Injection site reaction	Solicited local reactions at the injection site characterized by frequency, severity, and duration, recorded up to 7 days after dosing (Day 8)	Day 1- Day 8 (7 days)
Solicited systemic reaction frequency	Solicited systemic reactions characterized by frequency, severity, duration, and drug relationship, recorded up to 7 days after dosing (Day 8)	Day 1- Day 8 (7 days)
AE frequency	Adverse events (AEs), including unsolicited AEs, characterized by frequency, severity, duration, and drug relationship, for up to 28 days after dosing (Day 29)	Day 1- Day 29 (28 days)
Unsolicited treatment-emergent AE frequency	The proportion of subjects with at least 1 unsolicited treatment-emergent AE occurring up to 28 days after dosing (Day 29)	Day 1- Day 29 (28 days)
Medical AE frequency	Medically attended AEs (MAAEs) characterized by frequency, severity, duration, and drug relationship, from Day 1 until follow-up completion	Day 1- Day 365 (12 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SARS-CoV-2 antibody levels	Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-specific serum neutralizing antibody levels against ancestral and variant SARS-CoV-2 strains as compared to baseline (Day 1 predose) at 7, 14, and 28 days after dosing, and 2, 4, and 6 months after dosing: Geometric mean titers (GMTs) at each time point; Geometric mean-fold rise (GMFR) from before vaccination to each subsequent time point after vaccination; Seroresponse rate (SRR) defined as the proportion of subjects achieving ≥4-fold rise from before vaccination to each subsequent time point after vaccination	Day 1- Day 181 (~6 months)
SARS-CoV-2 anti-receptor antibody levels	SARS-CoV-2 anti-receptor binding domain (RBD) antibody levels as compared to baseline (Day 1 predose) at 7, 14, and 28 days after dosing, and 2, 4, and 6 months after dosing; Geometric mean concentrations (GMCs) at each time point; GMFR from before vaccination to each subsequent time point after vaccination; SRR defined as the proportion of subjects achieving ≥4-fold rise from before vaccination to each subsequent time point after vaccination	Day 1- Day 181 (~6 months)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
T-cell responses	T-cell responses to vaccine-encoded antigen and antigen-specific memory B cells and plasmablasts in peripheral blood mononuclear cells determined by enzyme-linked immunosorbent spot (ELISpot) assays, as compared to baseline (Day 1 predose) at 14 days and 6 months after dosing (Day 15 and Month 6)	Day 1- Day 181 (~6 months)

Collaborators and Investigators

• Sponsor: Immorna Biotherapeutics, Inc.
• Collaborators: ICON plc

Study record dates

Study Major Dates

• Study Start (Anticipated): March 20, 2023
• Primary Completion (Anticipated): September 6, 2024
• Study Completion (Anticipated): October 4, 2024

Study Registration Dates

• First Submitted: February 22, 2023
• First Submitted That Met QC Criteria: February 22, 2023
• First Posted (Actual): February 24, 2023

Study Record Updates

• Last Update Posted (Actual): March 17, 2023
• Last Update Submitted That Met QC Criteria: March 16, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Healthy subjects; COVID vaccination; mRNA Vaccine
• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; COVID-19; Infections; Communicable Diseases
• Other Study ID Numbers: JCXH-221-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No