Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 3:12 AM
Study NCT ID:
NCT07354659
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-21
First Post:
2025-12-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immunogenicity and Safety of SYS6017 in the Participants Aged 40 Years and Above
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006562', 'term': 'Herpes Zoster'}], 'ancestors': [{'id': 'D000073618', 'term': 'Varicella Zoster Virus Infection'}, {'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized, placebo or active-controlled, Masking'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 800}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2027-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-12', 'studyFirstSubmitDate': '2025-12-30', 'studyFirstSubmitQcDate': '2026-01-12', 'lastUpdatePostDateStruct': {'date': '2026-01-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'solicited adverse events', 'timeFrame': 'within 14 days post each vaccination'}, {'measure': 'unsolicited adverse events', 'timeFrame': 'within 30 days post each vaccination'}, {'measure': 'Geometric Mean Concentration (GMC) of anti-gE antibody', 'timeFrame': 'On Day 14 and Day 30 after the completion of the full vaccination course'}, {'measure': 'Geometric Mean Fold Increase (GMFI) of anti-gE antibody', 'timeFrame': 'On Day 14 and Day 30 after the completion of the full vaccination course'}, {'measure': 'Seroconversion Rate (SCR) of anti-gE antibody', 'timeFrame': 'On Day 14 and Day 30 after the completion of the full vaccination course'}], 'secondaryOutcomes': [{'measure': 'serious adverse events', 'timeFrame': 'from the first vaccination through 12 months post the second vaccination'}, {'measure': 'adverse events of special interest', 'timeFrame': 'from the first vaccination through 12 months post the second vaccination'}, {'measure': 'pregnancy events reported by the participants', 'timeFrame': 'from the first vaccination through 12 months post the second vaccination'}, {'measure': 'Geometric Mean Titer (GMT) of anti-VZV antibody', 'timeFrame': 'On Day 14 after the completion of the full vaccination course'}, {'measure': 'Geometric Mean Fold Increase (GMFI) of anti-VZV antibody', 'timeFrame': 'On Day 14 after the completion of the full vaccination course'}, {'measure': 'Seroconversion Rate (SCR) of anti-VZV antibody', 'timeFrame': 'On Day 14 after the completion of the full vaccination course'}, {'measure': 'cellular immune response', 'timeFrame': 'On Day 14 and Day 30 after the completion of the full vaccination course', 'description': 'the frequency of peripheral blood mononuclear cell (PBMC) secreting gE-specific cytokines'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Herpes Zoster']}, 'descriptionModule': {'briefSummary': 'Herpes zoster is caused by the reactivation of latent varicella-zoster virus (VZV) which stays in latency after its primary infection. Immunosenescence contributes significantly to elevating morbidity associated with aging. Vaccination plays a key role in reducing the disease burden of zoster and the associated complications. We are conducting a study entitled "A Randomized, Blinded, Placebo- and Active-Controlled, Adaptive Phase 2 Clinical Trial to Evaluate the Immunogenicity and Safety of SYS6017 (a Herpes Zoster mRNA Vaccine) in Healthy Participants Aged 40 Years and Above".'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. Individuals aged 40 years or older;\n* 2\\. Able to understand the study procedures, comply with the protocol requirements to attend all the scheduled visits, voluntarily consent to participate in the study, and sign the informed consent form;\n* 3\\. Is physically eligible at the discretion of investigators based on medical history inquiry and physical examination; For participants with chronic underlying diseases (e.g., diabetes mellitus, hypertension, hyperlipidemia and other chronic conditions), they may be enrolled if their conditions have been well controlled within 3 months prior to enrollment in this study (i.e., additional medical interventions or major adjustments to treatments are not required);\n* 4\\. For female participants of childbearing potential: No sexual activity or effective contraceptive methods were used within one menstrual cycle before enrollment; No pregnancy plans and agree to adopt effective contraceptive methods within 8 months after enrollment.\n\nExclusion Criteria:\n\n* 1\\. History of zoster;\n* 2\\. History of vaccination with varicella vaccine or zoster vaccine (including investigational vaccine);\n* 3\\. Axillary temperature ≥ 37.1℃ on the day of enrollment or within 24 h before enrollment;\n* 4\\. History of allergy to any component of the investigational vaccine; or history of severe allergic reactions to vaccines or medications (including but not limited to anaphylaxis, allergic laryngeal edema, Henoch-Schönlein purpura, thrombocytopenic purpura, or Arthus reaction);\n* 5\\. History of myocarditis, pericarditis, or idiopathic cardiomyopathy, or any condition that could increases the risk of myocarditis or pericarditis\n* 6\\. History of demyelinating diseases, including but not limited to Guillain-Barré syndrome, multiple sclerosis, ophthalmoneuromyelitis, acute disseminated encephalomyelitis, etc.;\n* 7\\. Current epilepsy or convulsion, severe neurological or psychiatric disorders;\n* 8\\. Have contraindications to intramuscular injection, e.g., diagnosed thrombocytopenia, any coagulation disorders, or ongoing treatment with anticoagulants, etc.;\n* 9\\. Active malignant tumor, malignant tumor without adequate treatment, malignant tumor with a potential risk of recurrence during the study;\n* 10\\. Active, unstable, severe or uncontrolled cardiovascular and cerebrovascular diseases, thrombotic diseases, blood and lymphatic system diseases, liver and kidney diseases, respiratory diseases, metabolic diseases, musculoskeletal diseases, autoimmune diseases, etc;\n* 11\\. History of diagnosed immunocompromise or immunosuppression, congenital or functional asplenia, or splenectomy before enrollment;\n* 12\\. Long-term (defined as more than 14 consecutive days) systemic use of immunosuppressants, immunostimulants, or other immunomodulatory drugs (e.g., corticosteroids at a dose of ≥ 20 mg/day prednisone or equivalent) within 6 months prior to enrollment; however, inhaled and topical corticosteroids are permitted; or planned administration of the aforementioned agents during the study period;\n* 13\\. Administration of whole blood, plasma, serum, immunoglobulin, or monoclonal antibodies within 3 months prior to enrollment, or planned administration of the aforementioned products during the study period;\n* 14\\. Blood donation or blood loss ≥ 450 mL within one month before enrollment, or planning to donate blood during the study;\n* 15\\. Vaccination with any other vaccines within 30 days prior to enrollment, or planned vaccination with any other vaccines within 30 days after the last dose of the study vaccine;\n* 16\\. Current participation in or planned participation in other clinical trials during the study period;\n* 17\\. For female participants of childbearing potential: positive pregnancy test result prior to enrollment, current pregnancy or lactation, or planned pregnancy within 8 months after enrollment;\n* 18\\. Unable to comply with the study procedures and requirements, or presence of other conditions that make the participant inappropriate for this clinical trial, as judged by the investigators.'}, 'identificationModule': {'nctId': 'NCT07354659', 'briefTitle': 'Immunogenicity and Safety of SYS6017 in the Participants Aged 40 Years and Above', 'organization': {'class': 'INDUSTRY', 'fullName': 'CSPC Megalith Biopharmaceutical Co.,Ltd.'}, 'officialTitle': 'A Randomized, Blinded, Placebo- and Active-Controlled, Adaptive Phase 2 Study to Evaluate the Immunogenicity and Safety of SYS6017 (a Herpes Zoster mRNA Vaccine) in Healthy Participants Aged 40 Years and Above', 'orgStudyIdInfo': {'id': 'SYS6017-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dosage A of zoster mRNA vaccine SYS6017', 'interventionNames': ['Biological: A zoster mRNA vaccine SYS6017']}, {'type': 'EXPERIMENTAL', 'label': 'Dosage B of zoster mRNA vaccine SYS6017', 'interventionNames': ['Biological: A zoster mRNA vaccine SYS6017']}, {'type': 'EXPERIMENTAL', 'label': 'Dosage C of zoster mRNA vaccine SYS6017', 'interventionNames': ['Biological: A zoster mRNA vaccine SYS6017']}, {'type': 'EXPERIMENTAL', 'label': 'Dosage D of zoster mRNA vaccine SYS6017', 'interventionNames': ['Biological: A zoster mRNA vaccine SYS6017']}, {'type': 'EXPERIMENTAL', 'label': 'Dosage E of zoster mRNA vaccine SYS6017', 'interventionNames': ['Biological: A zoster mRNA vaccine SYS6017']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Other: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Active Comparator Vaccine', 'interventionNames': ['Biological: Active Comparator Vaccine']}], 'interventions': [{'name': 'A zoster mRNA vaccine SYS6017', 'type': 'BIOLOGICAL', 'description': 'SYS6017，two-dose vaccination schedule (Month 0, 2)', 'armGroupLabels': ['Dosage A of zoster mRNA vaccine SYS6017', 'Dosage B of zoster mRNA vaccine SYS6017', 'Dosage C of zoster mRNA vaccine SYS6017', 'Dosage D of zoster mRNA vaccine SYS6017', 'Dosage E of zoster mRNA vaccine SYS6017']}, {'name': 'Placebo', 'type': 'OTHER', 'description': '0.9% saline，two-dose vaccination schedule (Month 0, 2)', 'armGroupLabels': ['Placebo']}, {'name': 'Active Comparator Vaccine', 'type': 'BIOLOGICAL', 'description': 'Recombinant Zoster Vaccine (CHO cell)，two-dose vaccination schedule (Month 0, 2)', 'armGroupLabels': ['Active Comparator Vaccine']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Clinical Trials Information Group officer', 'role': 'CONTACT', 'email': 'ctr-contact@cspc.cn', 'phone': '86-0311-69085587'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CSPC Megalith Biopharmaceutical Co.,Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}