Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 11:46 PM
Study NCT ID:
NCT06564194
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-30
First Post:
2024-08-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 1 Study to Evaluate JCXH-108, an mRNA-based Vaccine Against RSV
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003141', 'term': 'Communicable Diseases'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'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': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-09-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-28', 'studyFirstSubmitDate': '2024-08-19', 'studyFirstSubmitQcDate': '2024-08-19', 'lastUpdatePostDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'T-cell responses', 'timeFrame': 'Day 1 -Day 180 (6 Months)', 'description': 'T-cell responses to vaccine-encoded antigen in peripheral blood mononuclear cells (PBMCs) determined by enzyme-linked immunosorbent spot (ELISpot) and Intracellular Cytokine Staining (ICS) assays, as compared to baseline (Day 1 pre-dose) at 29 days and 6 months after the vaccine administration (Day 30 and Month 6).'}], 'primaryOutcomes': [{'measure': 'SAE Frequency', 'timeFrame': 'Day 1 - Day 180 (6 Months)', 'description': 'Frequency of SAEs characterized by type, severity, duration, and relationship to the JCXH-108 recorded from Day 1 (D1) post-vaccine administration through follow-up completion.'}, {'measure': 'Injection site reaction', 'timeFrame': 'Day 1 - Day 30', 'description': 'Solicited local injection site reactions characterized by frequency, severity, and duration recorded within 30 days after administration after vaccine administration (JCXH-108 or Placebo)'}, {'measure': 'Solicited systemic reaction frequency', 'timeFrame': 'Day 1 - Day 30', 'description': 'Solicited systemic adverse reactions characterized by frequency, severity, and duration recorded within 30 days after vaccine administration (JCXH-108 or Placebo)'}, {'measure': 'AE frequency', 'timeFrame': 'Day 1 -Day 30', 'description': 'Adverse events (AEs) including unsolicited AEs characterized by type, severity, duration, and relationship to the vaccine (JCXH-108 or Placebo) recorded from Day 1 post-vaccine administration to within 30 days following vaccine administration'}, {'measure': 'Medically attended AE frequency', 'timeFrame': 'Day 1 - Day 180 (6 Months)', 'description': 'Medically attended AEs (MAAEs) characterized by frequency, severity, duration, and relationship to the vaccine (JCXH-108 or Placebo) recorded from Day 1 post-vaccine administration (JCXH-108 or Placebo) through follow-up completion'}, {'measure': 'Potential immune-mediated adverse events frequency', 'timeFrame': 'Day 1 - Day 180 (6 Months)', 'description': 'Potential immune-mediated disease (pIMDs) characterized by frequency, severity, duration, and relationship to the vaccine (JCXH-108 or Placebo) recorded from Day 1 post-vaccine administration (JCXH-108 or Placebo) through follow-up completion'}], 'secondaryOutcomes': [{'measure': 'RSV-A and RSV-B antibody levels', 'timeFrame': 'Day 1 - Day 180 (6 Months)', 'description': 'Levels of serum neutralizing antibodies against RSV-A and RSV-B as compared to Day 1 pre-dose (baseline) at Day 29, Month 3 and Month 6 after the vaccine administration'}, {'measure': 'IgG antibody levels', 'timeFrame': 'Day 1 - Day 30', 'description': 'Levels of serum RSV pre-F antibodies of IgG1, IgG2, IgG3, and IgG4 as compared to Day 1 pre-dose (baseline) at Day 29, after the vaccine administration. Measured in women of childbearing potential only.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['mRNA vaccine', 'RSV vaccination', 'Healthy subjects'], 'conditions': ['Respiratory Syncytial Virus (RSV)', 'Infectious Disease']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to assess the safety, reactogenicity and immunogenicity of an mRNA-based vaccine, JCXH-108, the prevention of Respiratory Syncytial Virus (RSV) infection and diseases.\n\nParticipants will be randomized to receive either JCXH-108 or placebo.', 'detailedDescription': 'This Phase 1 study plans to enroll a total of 75 participants.\n\nThree cohorts with two different dose levels will be explored and each cohort will enroll 25 participants. Participants in each cohort will be randomized (4:1) to receive either JCXH-108 (n=20) or placebo (normal saline, n=5). A low dose of JCXH-108 will be explored vs placebo in the 18-45 years of age group first. A high dose will be explored vs placebo in the 18-45 years and ≥ 60 years of age groups once safety data is reviewed for the Sentinel subjects in the low dose cohort. The dose level of JCXH-108 will depend on the time the participant joins the study. Each participant will receive a single dose of JCXH-108 administered intramuscularly (IM) on day 1.'}, '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 or postmenopausal.\n* Age: 18-45 years of age or ≥ 60 years of age at screening\n* Status: Healthy subjects.\n* Subjects must agree to not be vaccinated with any RSV vaccine while participating in this study.\n* Subjects must agree to not be vaccinated with any RNA-based vaccines 30 days before D1 through 30 days after D1.\n\nMain Exclusion Criteria:\n\n* Subjects with current diagnosis of RSV infection or diseases.\n* Previous vaccination against RSV.\n* Subjects with any respiratory illness deemed clinically relevant by the Investigator within the past month OR hospitalization \\>24 hours for any reason within the past month prior to Day 1.\n* Subjects with history of myocarditis or pericarditis, or with adverse events (AEs) after mRNA vaccination that are in nature and severity beyond the common expected AEs necessitating medical intervention.\n* Subjects who received any non-live vaccine within 14 days prior to Day 1.\n* Subjects who received within 28 days prior to Day 1: (1) Any live vaccine, (2) Immunomodulators or immune-suppressive medication, (3) Granulocyte or granulocyte-macrophage colony-stimulating factor, and (4) Three or more consecutive days of systemic corticosteroids. Note: subjects on stable dose of steroid replacement (for chronic disease such as iatrogenic deficiency) of prednisone ≤10 mg/day or equivalent are allowed.\n* Subjects who currently receive other investigational agents or devices.\n* Subjects with active or suspected immunosuppression, immunodeficiency, asplenia, recurrent severe infections or autoimmune diseases. Certain immune-mediated conditions (e.g., Hashimoto thyroiditis) that are well controlled and stable are allowed.\n* Subjects receiving systemic antiviral therapy.\n* Subjects with a positive screening test for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies, or anti-human HIV-1 and 2 antibodies, syphilis.\n* Subjects with a positive test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at Screening or on Day 1 prior to vaccine administration (JCXH-108 or placebo).'}, 'identificationModule': {'nctId': 'NCT06564194', 'briefTitle': 'A Phase 1 Study to Evaluate JCXH-108, an mRNA-based Vaccine Against RSV', 'organization': {'class': 'INDUSTRY', 'fullName': 'Immorna Biotherapeutics, Inc.'}, 'officialTitle': 'A Phase 1 Randomized, Double-Blinded Study to Assess the Safety, Reactogenicity and Immunogenicity of JCXH-108, an mRNA-based Investigational Vaccine Against Respiratory Syncytial Virus (RSV) in Healthy Subjects ≥ 60 Years of Age and 18-45 Years of Age', 'orgStudyIdInfo': {'id': 'JCXH-108-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Investigational product', 'description': 'Subjects randomized to this arm will be given the investigational product (JCXH-108).', 'interventionNames': ['Biological: JCXH-108']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Subjects randomized to this arm will be given a placebo.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'JCXH-108', 'type': 'BIOLOGICAL', 'description': 'IM injection', 'armGroupLabels': ['Investigational product']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'IM injection', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33458', 'city': 'Jupiter', 'state': 'Florida', 'country': 'United States', 'facility': 'Health Awareness', 'geoPoint': {'lat': 26.93422, 'lon': -80.09421}}, {'zip': '70115', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'DelRicht - New Orleans', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '63131', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Sundance Clinical Research', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Immorna Biotherapeutics, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Tigermed Consulting Co., Ltd', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}