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Completed

NCT Number: NCT05743335

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

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.

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Key information

Conditions

COVID-19 Communicable Diseases Coronaviridae Infections Coronavirus Infections Disease Attributes Infections Infectious Disease Lung Diseases Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Velocity Clinical Research, Hallandale, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Placebo

Other

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

Primary outcomes

  1. SAE frequency

    Time frame: Day 1- Day 365 (12 months)

    Frequency of serious adverse events (SAEs) characterized by type, severity, duration, and drug relationship, from Day 1 (dosing day) until follow-up completion

  2. Injection site reaction

    Time frame: Day 1- Day 8 (7 days)

    Solicited local reactions at the injection site characterized by frequency, severity, and duration, recorded up to 7 days after dosing (Day 8)

  3. Solicited systemic reaction frequency

    Time frame: Day 1- Day 8 (7 days)

    Solicited systemic reactions characterized by frequency, severity, duration, and drug relationship, recorded up to 7 days after dosing (Day 8)

  4. AE frequency

    Time frame: Day 1- Day 29 (28 days)

    Adverse events (AEs), including unsolicited AEs, characterized by frequency, severity, duration, and drug relationship, for up to 28 days after dosing (Day 29)

  5. Unsolicited treatment-emergent AE frequency

    Time frame: Day 1- Day 29 (28 days)

    The proportion of subjects with at least 1 unsolicited treatment-emergent AE occurring up to 28 days after dosing (Day 29)

  6. Medical AE frequency

    Time frame: Day 1- Day 365 (12 months)

    Medically attended AEs (MAAEs) characterized by frequency, severity, duration, and drug relationship, from Day 1 until follow-up completion

Secondary outcomes

  1. SARS-CoV-2 antibody levels

    Time frame: Day 1- Day 181 (~6 months)

    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

  2. SARS-CoV-2 anti-receptor antibody levels

    Time frame: Day 1- Day 181 (~6 months)

    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

Other outcomes

  1. T-cell responses

    Time frame: Day 1- Day 181 (~6 months)

    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)

Sponsors and collaborators

Lead sponsor

Immorna Biotherapeutics, Inc.

Industry

Collaborators

  • ICON plc

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 24, 2023
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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