Clinical trial NCT05743335: A Phase 1 Study to Assess the Safety and Immunogenicity of JCXH-221, an MRNA-based Broadly Protective COVID-19 Vaccine
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: COVID-19
Infectious Disease
Keywords: mRNA Vaccine
COVID vaccination
Healthy subjects
Lead sponsor: Immorna Biotherapeutics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: ICON plc
First posted: 2023-02-24
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 age groups will be enrolled in parallel for Phase 1 (18-64 age group and 65+ age group).
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: SAE frequency
timeFrame: Day 1- Day 365 (12 months)
measure: Injection site reaction
timeFrame: Day 1- Day 8 (7 days)
measure: Solicited systemic reaction frequency
timeFrame: Day 1- Day 8 (7 days)
measure: AE frequency
timeFrame: Day 1- Day 29 (28 days)
measure: Unsolicited treatment-emergent AE frequency
timeFrame: Day 1- Day 29 (28 days)
measure: Medical AE frequency
timeFrame: Day 1- Day 365 (12 months)
Secondary outcomes:
measure: SARS-CoV-2 antibody levels
timeFrame: Day 1- Day 181 (~6 months)
measure: SARS-CoV-2 anti-receptor antibody levels
timeFrame: Day 1- Day 181 (~6 months)
Other outcomes:
measure: T-cell responses
timeFrame: Day 1- Day 181 (~6 months)
Locations:
city: Hallandale Beach
country: United States
facility: Velocity Clinical Research
state: Florida
city: Savannah
country: United States
facility: Velocity Clinical Research
state: Georgia
city: Lincoln
country: United States
facility: Velocity Clinical Research
state: Nebraska
city: Cedar Park
country: United States
facility: Velocity Clinical Research
state: Texas
Study officials:
References: