COVID-19Phase 1NCT05743335
A Phase 1 Study to Assess the Safety and Immunogenicity of JCXH-221, an MRNA-based Broadly Protective COVID-19 Vaccine
A Phase 1 study testing JCXH-221 in people with COVID-19 and Infectious Disease, run by Immorna Biotherapeutics, Inc. at 4 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19, Infectious Disease
- What is being tested?
- JCXH-221
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 73 participants
- Where
- 4 sitesUnited States
- Study dates
- 7 Mar 2023to 1 Dec 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Velocity Clinical Research
Cedar Park, Texas, 78613
Velocity Clinical Research
Hallandale, Florida, 33009
Velocity Clinical Research
Lincoln, Nebraska, 68510
Velocity Clinical Research
Savannah, Georgia, 31406
About this study
Official 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
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.
Read the 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.
- Conditions
- COVID-19, Infectious Disease
- Being tested
- JCXH-221, Placebo
- Keywords
- mRNA Vaccine, COVID vaccination, Healthy subjects
- Medical subject headings
- COVID-19, Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JCXH-221Biological
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.
PlaceboOther
Participants will be randomized in Phase 1 to either JCXH-221 or placebo
| Study group | Role | What they receive |
|---|---|---|
| Investigational product | Experimental | Patients randomized to this arm will be given the investigational product (JCXH-221). Receives: Biological: JCXH-221 |
| Placebo | Placebo comparator | Patients randomized to this arm will be given a placebo vaccine. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: Day 1- Day 365 (12 months)
Secondary outcomes (2)
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
Measured: 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
Measured: Day 1- Day 181 (~6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2023
- Study start7 Mar 2023
- Primary completion1 Dec 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 age groups will be enrolled in parallel for Phase 1 (18-64 age group and 65+ age group).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Immorna Biotherapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ICON plc
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05743335
- Sponsor's protocol ID
- JCXH-221-001
- Status last verified
- Mar 2023
- First submitted
- 22 Feb 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05743335
- Acronym / sponsor ID
- JCXH-221-001
- Conditions
- COVID-19, Infectious Disease
- Keywords
- mRNA Vaccine, COVID vaccination, Healthy subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Immorna Biotherapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- ICON plc
- Study start
- 7 Mar 2023 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 24 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 2 age groups will be enrolled in parallel for Phase 1 (18-64 age group and 65+ age group).
| Arm | Type | Receives |
|---|---|---|
| Investigational product | Experimental | Biological: JCXH-221Patients randomized to this arm will be given the investigational product (JCXH-221). |
| Placebo | Placebo comparator | Other: PlaceboPatients randomized to this arm will be given a placebo vaccine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JCXH-221Participants 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. | Biological | Investigational product |
| PlaceboParticipants will be randomized in Phase 1 to either JCXH-221 or placebo | Other | Placebo |
Primary outcome
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
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)
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)
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)
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)
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
2 secondary outcomes
SARS-CoV-2 antibody levels
Time frame: Day 1- Day 181 (~6 months)
SARS-CoV-2 anti-receptor antibody levels
Time frame: Day 1- Day 181 (~6 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JCXH-221 in people with COVID-19 and Infectious Disease, run by Immorna Biotherapeutics, Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SAE frequency (time frame: Day 1- Day 365 (12 months)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.