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

NCT05743335 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: JCXH-221-001
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 4

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.

Conditions

COVID-19; Infectious Disease

Keywords

mRNA Vaccine; COVID vaccination; Healthy subjects

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (2)

• SARS-CoV-2 antibody levels

  Day 1- Day 181 (~6 months)

• SARS-CoV-2 anti-receptor antibody levels

  Day 1- Day 181 (~6 months)

Other Outcomes (1)

• T-cell responses

  Day 1- Day 181 (~6 months)

Study Arms (2)

Investigational product

EXPERIMENTAL

Patients randomized to this arm will be given the investigational product (JCXH-221).

Biological: JCXH-221

Placebo

PLACEBO COMPARATOR

Patients randomized to this arm will be given a placebo vaccine.

Other: Placebo

Interventions

JCXH-221 BIOLOGICAL

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.

Investigational product

Placebo OTHER

Participants will be randomized in Phase 1 to either JCXH-221 or placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Immorna Biotherapeutics, Inc.: lead
• ICON plc: collaborator

Study Sites (4)

Velocity Clinical Research

Hallandale, Florida, 33009, United States

Location

Velocity Clinical Research

Savannah, Georgia, 31406, United States

Location

Velocity Clinical Research

Lincoln, Nebraska, 68510, United States

Location

Velocity Clinical Research

Cedar Park, Texas, 78613, United States

Location

MeSH Terms

Conditions

COVID-19; Communicable Diseases

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blinded study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 2 age groups will be enrolled in parallel for Phase 1 (18-64 age group and 65+ age group).

Study Record Dates

• First Submitted: February 22, 2023
• First Posted: February 24, 2023
• Study Start: March 7, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: September 19, 2024

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)