A Phase 1/2 Study to Assess the Safety and Immunogenicity of JCXH-221, an mRNA-based Broadly Protective COVID-19 Vaccine
- Conditions
- Infectious DiseaseCOVID-19
- Interventions
- Other: Placebo
- Registration Number
- NCT05743335
- Lead Sponsor
- Immorna Biotherapeutics, Inc.
- 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. In Phase 2, participants will be randomized to either JCXH-221 or a FDA approved Active comparator.
- Detailed Description
This is a phase 1/2 study looking to enroll a total of 262 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. A high dose for those 2 cohorts will be explored once all safety data is reviewed.
Once all of Phase 1 data has been reviewed, Phase 2 enrollment will open. In this portion of the trial, subjects will be enrolled and randomized to either JCXH-221 or a FDA approved Active comparator (Pfizer, Moderna, etc.). A total of 190 patients will be enrolled.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 262
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Investigational product JCXH-221 Patients randomized to this arm will be given the investigational product (JCXH-221). Placebo Placebo Patients randomized to this arm will be given a placebo vaccine.
- Primary Outcome Measures
Name Time Method 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
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)
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)
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)
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)
- Secondary Outcome Measures
Name Time Method 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 vaccinationSARS-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
Trial Locations
- Locations (1)
Velocity Clinical Research
🇺🇸Cedar Park, Texas, United States