Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 8:44 PM
Study NCT ID:
NCT07481604
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-19
First Post:
2026-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Immunogenicity of CVI-VZV-001 in Adults Aged 50 Years and Above
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006562', 'term': 'Herpes Zoster'}, {'id': 'D002644', 'term': 'Chickenpox'}], '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': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 135}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-16', 'studyFirstSubmitDate': '2026-03-13', 'studyFirstSubmitQcDate': '2026-03-16', 'lastUpdatePostDateStruct': {'date': '2026-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Geometric Mean Fold Rise (GMFR) of Anti-VZV gE Antibody', 'timeFrame': 'Baseline to 4 weeks after the second vaccination', 'description': 'Geometric mean fold rise (GMFR) of anti-VZV gE antibodies measured by ELISA from baseline to 4 weeks after the second vaccination.'}], 'secondaryOutcomes': [{'measure': 'Geometric Mean Fold Rise (GMFR) of Anti-VZV gE Antibody at Additional Time Points', 'timeFrame': 'Before the second vaccination and at 8 and 24 weeks after the second vaccination', 'description': 'Geometric mean fold rise (GMFR) of anti-VZV glycoprotein E (gE) antibody levels measured by ELISA relative to baseline.'}, {'measure': 'Geometric Mean Concentration (GMC) of Anti-VZV gE Antibody', 'timeFrame': 'Before the second vaccination and at 4, 8, and 24 weeks after the second vaccination', 'description': 'Geometric mean concentration (GMC) of anti-VZV glycoprotein E (gE) antibody levels measured by ELISA.'}, {'measure': 'Vaccine Response Rate (VRR) of Anti-VZV gE Antibody', 'timeFrame': 'Before the second vaccination and at 4, 8, and 24 weeks after the second vaccination', 'description': 'Proportion of participants achieving a predefined vaccine response in anti-VZV glycoprotein E (gE) antibody levels measured by ELISA.'}, {'measure': 'Polyfunctional CD4+ T Cell Response', 'timeFrame': '4 and 8 weeks after the second vaccination', 'description': 'Frequency of polyfunctional CD4+ T cells defined as CD4+ T cells producing at least two activation markers (IFN-γ, IL-2, TNF-α, CD40L \\[CD154\\]) following stimulation with VZV glycoprotein E peptides.'}, {'measure': 'Geometric Mean Concentration (GMC) of Anti-VZV Antibody', 'timeFrame': 'Before the second vaccination and at 4, 8, and 24 weeks after the second vaccination', 'description': 'Geometric mean concentration (GMC) of anti-varicella-zoster virus (VZV) antibodies measured by ELISA.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Herpes Zoster Vaccine', 'Shingles', 'Varicella Zoster Virus', 'Immunogenicity'], 'conditions': ['Herpes Zoster']}, 'descriptionModule': {'briefSummary': 'To evaluate the immunogenicity of the investigational product (IP) in healthy adults aged 50 years or older and to explore differences in immune responses between the experimental and control groups, and to determine the optimal dose of the IP.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants must meet all of the following criteria:\n\n * Healthy adults aged 50 years or older\n * Able to understand the study procedures and provide written informed consent\n * Females and males of reproductive potential must agree to use medically acceptable contraception until 3 months after the last vaccination\n * Females of childbearing potential must have a negative pregnancy test prior to vaccination\n\nExclusion Criteria:\n\n* Participants meeting any of the following criteria will be excluded:\n\n * History of herpes zoster prior to screening\n * History of severe allergic reaction to vaccines or vaccine components\n * Known immunodeficiency or immune dysfunction\n * Prior vaccination with varicella or herpes zoster vaccine\n * Use of immunosuppressive therapy or systemic steroids that may affect immune response\n * Positive test for HCV, HBV, or HIV at screening\n * Pregnant or breastfeeding women\n * Any medical condition that, in the opinion of the investigator, would make participation unsafe or interfere with study evaluation'}, 'identificationModule': {'nctId': 'NCT07481604', 'briefTitle': 'Safety and Immunogenicity of CVI-VZV-001 in Adults Aged 50 Years and Above', 'organization': {'class': 'INDUSTRY', 'fullName': 'CHA Vaccine Institute Co., Ltd.'}, 'officialTitle': 'A Multicenter, Active-controlled, Randomized, Double Blinded, Parallel, Phase II Study to Assess the Immunogenicity and Safety of CVI-VZV-001 in Healthy Adults Aged 50 Years and Above', 'orgStudyIdInfo': {'id': 'CVI-VZV-001-CT2501-B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CVI-VZV-001 Low Dose', 'description': 'Participants receive two doses of the investigational herpes zoster vaccine CVI-VZV-001 at the low dose level administered intramuscularly on Day 0 and Week 8.', 'interventionNames': ['Biological: CVI-VZV-001']}, {'type': 'EXPERIMENTAL', 'label': 'CVI-VZV-001 High Dose', 'description': 'Participants receive two doses of the investigational herpes zoster vaccine CVI-VZV-001 at the high dose level administered intramuscularly on Day 0 and Week 8.', 'interventionNames': ['Biological: CVI-VZV-001']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Shingrix', 'description': 'Participants receive two doses of the licensed herpes zoster vaccine Shingrix administered intramuscularly on Day 0 and Week 8.', 'interventionNames': ['Biological: Shingrix']}], 'interventions': [{'name': 'Shingrix', 'type': 'BIOLOGICAL', 'description': 'Licensed herpes zoster vaccine used as an active comparator.', 'armGroupLabels': ['Shingrix']}, {'name': 'CVI-VZV-001', 'type': 'BIOLOGICAL', 'description': 'Investigational herpes zoster vaccine.', 'armGroupLabels': ['CVI-VZV-001 High Dose', 'CVI-VZV-001 Low Dose']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Daegu', 'state': 'Daegu', 'country': 'South Korea', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT'}], 'facility': 'Kyungpook National University Chilgok Hospital', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT'}], 'facility': 'CHA Bundang Medical Center', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}, {'city': 'Yongin', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT'}], 'facility': 'Yongin Severance Hospital, Yonsei University Health System'}, {'city': 'Jeonju', 'state': 'Jeollabuk-do', 'country': 'South Korea', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT'}], 'facility': 'Jeonbuk National University Hospital', 'geoPoint': {'lat': 35.82194, 'lon': 127.14889}}, {'zip': '03312', 'city': 'Seoul', 'state': 'Seoul', 'country': 'South Korea', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT'}], 'facility': "The Catholic University of Korea Eunpyeong St. Mary's Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'state': 'Seoul', 'country': 'South Korea', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT'}], 'facility': 'Chung-Ang University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'state': 'Seoul', 'country': 'South Korea', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT'}], 'facility': 'Ewha Womans University Seoul Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Jinsol Lee', 'role': 'CONTACT', 'email': 'jsleee@chabio.com', 'phone': '+82-31-881-7716'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CHA Vaccine Institute Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}