Ignite Creation Date:
2025-12-24 @ 10:32 PM
Ignite Modification Date:
2025-12-28 @ 11:02 AM
Study NCT ID:
NCT05743335
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2023-02-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 1 Study to Assess the Safety and Immunogenicity of JCXH-221, an MRNA-based Broadly Protective COVID-19 Vaccine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D003141', 'term': 'Communicable Diseases'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Double blinded study'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '2 age groups will be enrolled in parallel for Phase 1 (18-64 age group and 65+ age group).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 73}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-09', 'studyFirstSubmitDate': '2023-02-22', 'studyFirstSubmitQcDate': '2023-02-22', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'T-cell responses', 'timeFrame': 'Day 1- Day 181 (~6 months)', 'description': '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)'}], 'primaryOutcomes': [{'measure': 'SAE frequency', 'timeFrame': 'Day 1- Day 365 (12 months)', 'description': 'Frequency of serious adverse events (SAEs) characterized by type, severity, duration, and drug relationship, from Day 1 (dosing day) until follow-up completion'}, {'measure': 'Injection site reaction', 'timeFrame': 'Day 1- Day 8 (7 days)', 'description': 'Solicited local reactions at the injection site characterized by frequency, severity, and duration, recorded up to 7 days after dosing (Day 8)'}, {'measure': 'Solicited systemic reaction frequency', 'timeFrame': 'Day 1- Day 8 (7 days)', 'description': 'Solicited systemic reactions characterized by frequency, severity, duration, and drug relationship, recorded up to 7 days after dosing (Day 8)'}, {'measure': 'AE frequency', 'timeFrame': 'Day 1- Day 29 (28 days)', 'description': 'Adverse events (AEs), including unsolicited AEs, characterized by frequency, severity, duration, and drug relationship, for up to 28 days after dosing (Day 29)'}, {'measure': 'Unsolicited treatment-emergent AE frequency', 'timeFrame': 'Day 1- Day 29 (28 days)', 'description': 'The proportion of subjects with at least 1 unsolicited treatment-emergent AE occurring up to 28 days after dosing (Day 29)'}, {'measure': 'Medical AE frequency', 'timeFrame': 'Day 1- Day 365 (12 months)', 'description': 'Medically attended AEs (MAAEs) characterized by frequency, severity, duration, and drug relationship, from Day 1 until follow-up completion'}], 'secondaryOutcomes': [{'measure': 'SARS-CoV-2 antibody levels', 'timeFrame': 'Day 1- Day 181 (~6 months)', 'description': '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:\n\n* Geometric mean titers (GMTs) at each time point\n* Geometric mean-fold rise (GMFR) from before vaccination to each subsequent time point after vaccination\n* Seroresponse rate (SRR) defined as the proportion of subjects achieving ≥4-fold rise from before vaccination to each subsequent time point after vaccination'}, {'measure': 'SARS-CoV-2 anti-receptor antibody levels', 'timeFrame': 'Day 1- Day 181 (~6 months)', 'description': '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\n\n* Geometric mean concentrations (GMCs) at each time point\n* GMFR from before vaccination to each subsequent time point after vaccination\n* SRR defined as the proportion of subjects achieving ≥4-fold rise from before vaccination to each subsequent time point after vaccination'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['mRNA Vaccine', 'COVID vaccination', 'Healthy subjects'], 'conditions': ['COVID-19', 'Infectious Disease']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn about, test, and compare JCXH-221 in healthy volunteers. The main aims to answer are:\n\n* To assess the safety and tolerability of the JCXH-221 vaccine in healthy adult subjects\n* To identify an optimal dose for the JCXH-221 vaccine in healthy adult subjects\n* To assess the humoral immunogenicity of the JCXH-221 vaccine in healthy adult subjects\n* To characterize the cellular immunogenicity of the JCXH-221 vaccine in healthy adult subjects\n\nParticipants for Phase I will be randomized to either JCXH-221 or placebo.', 'detailedDescription': 'This is a phase 1 study looking to enroll a total of 72 patients.\n\nFor 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Main Inclusion Criteria\n\n* Sex: Male or female; female subjects may be of childbearing potential, of nonchildbearing potential, or postmenopausal.\n* Age: 18 years of age or older, at screening.\n* Status: Healthy subjects.\n* 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.\n\nMain Exclusion Criteria\n\n* 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.\n* 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.\n* Subjects with fever or signs of acute infection at the time of enrollment and vaccination.\n* Subjects who are taking medications that may prevent or treat COVID-19.\n* Subjects who received convalescent serum or prior therapeutic antibodies against SARS-CoV-2 within 4 months before Day 1.\n* 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.\n* Subjects with active or suspected immunosuppression, immunodeficiency, or autoimmune disease.'}, 'identificationModule': {'nctId': 'NCT05743335', 'briefTitle': 'A Phase 1 Study to Assess the Safety and Immunogenicity of JCXH-221, an MRNA-based Broadly Protective COVID-19 Vaccine', 'organization': {'class': 'INDUSTRY', 'fullName': 'Immorna Biotherapeutics, Inc.'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'JCXH-221-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Investigational product', 'description': 'Patients randomized to this arm will be given the investigational product (JCXH-221).', 'interventionNames': ['Biological: JCXH-221']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Patients randomized to this arm will be given a placebo vaccine.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'JCXH-221', 'type': 'BIOLOGICAL', 'description': '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.', 'armGroupLabels': ['Investigational product']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Participants will be randomized in Phase 1 to either JCXH-221 or placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33009', 'city': 'Hallandale', 'state': 'Florida', 'country': 'United States', 'facility': 'Velocity Clinical Research', 'geoPoint': {'lat': 25.9812, 'lon': -80.14838}}, {'zip': '31406', 'city': 'Savannah', 'state': 'Georgia', 'country': 'United States', 'facility': 'Velocity Clinical Research', 'geoPoint': {'lat': 32.08354, 'lon': -81.09983}}, {'zip': '68510', 'city': 'Lincoln', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Velocity Clinical Research', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}, {'zip': '78613', 'city': 'Cedar Park', 'state': 'Texas', 'country': 'United States', 'facility': 'Velocity Clinical Research', 'geoPoint': {'lat': 30.5052, 'lon': -97.82029}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Immorna Biotherapeutics, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'ICON plc', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}