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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
73
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.
Participants will be randomized in Phase 1 to either JCXH-221 or placebo
Velocity Clinical Research
Hallandale, Florida, United States
Velocity Clinical Research
Savannah, Georgia, United States
Velocity Clinical Research
Lincoln, Nebraska, United States
Velocity Clinical Research
Cedar Park, Texas, United States
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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: Day 1- Day 365 (12 months)
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
Time frame: Day 1- Day 181 (~6 months)
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
Time frame: Day 1- Day 181 (~6 months)
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