COVID-19, Infectious Disease
Conditions
Keywords
mRNA Vaccine, COVID vaccination, Healthy subjects
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.
Interventions
BIOLOGICALJCXH-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.
OTHERPlacebo
Participants will be randomized in Phase 1 to either JCXH-221 or placebo
Sponsors
ICON plc
Immorna Biotherapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double blinded study
Intervention model description
2 age groups will be enrolled in parallel for Phase 1 (18-64 age group and 65+ age group).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Medical AE frequency | 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 |
| Solicited systemic reaction frequency | 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) |
| AE frequency | 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) |
| Unsolicited treatment-emergent AE frequency | 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) |
| SAE frequency | 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 |
| Injection site reaction | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SARS-CoV-2 antibody levels | 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 |
| SARS-CoV-2 anti-receptor antibody levels | 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
| Measure | Time frame | Description |
|---|---|---|
| T-cell responses | 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) |
Countries
United States
Outcome results
None listed