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 Details — Status: Recruiting

Administrative data

• NCT number: NCT05743335
• Other study ID #: JCXH-221-001
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: March 20, 2023
• Est. completion date: October 4, 2024

Study information

• Verified date: March 2023
• Source: Immorna Biotherapeutics, Inc.
• Contact: Banji Oduola
• Phone: 630-687-3084
• Email: banji.oduola[@]immornabio.com
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 262
• Est. completion date: October 4, 2024
• Est. primary completion date: September 6, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• COVID-19
• Infections
• Infectious Disease

Intervention

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.
• Active Comparator
Participants will be randomized in Phase 2 to either JCXH-221 or a FDA approved Active Comparator,

Other:
• Placebo
Participants will be randomized in Phase 1 to either JCXH-221 or placebo

Locations

Country	Name	City	State
United States	Velocity Clinical Research	Cedar Park	Texas
United States	Velocity Clinical Research	Hallandale Beach	Florida
United States	Velocity Clinical Research	Lincoln	Nebraska
United States	Velocity Clinical Research	Savannah	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Immorna Biotherapeutics, Inc.	ICON plc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)