Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2025-12-25 @ 10:33 PM
Study NCT ID:
NCT05585567
Status:
UNKNOWN
Last Update Posted:
2022-11-07
First Post:
2022-10-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Preliminary Exploratory Study to Evaluate the Safety and Immunogenicity of Omicron Variant Bivalent Vaccine V-01-B5
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-09-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2023-09-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-11-03', 'studyFirstSubmitDate': '2022-10-13', 'studyFirstSubmitQcDate': '2022-10-16', 'lastUpdatePostDateStruct': {'date': '2022-11-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse Event (AE)', 'timeFrame': '30 minutes after vaccination', 'description': 'Observe the AEs occurs at different time point after vaccination'}, {'measure': 'AEs', 'timeFrame': '0-7 days after vaccination', 'description': 'Observe the AEs occurs at different time point after vaccination'}, {'measure': 'AEs', 'timeFrame': '0-28 days after vaccination', 'description': 'Observe the AEs occurs at different time point after vaccination'}, {'measure': 'Serious adverse event (SAE) and adverse event of special interest (AESI)', 'timeFrame': 'Within 12 months after vaccination', 'description': 'Observe the SAE and AESI after vaccination'}, {'measure': 'Neutralizing antibody geometric mean titer (GMT) of Omicron BA.5', 'timeFrame': '28 days after vaccination', 'description': 'Neutralizing antibody GMT of the most prevalent SARS-CoV-2 variant (Omicron BA.5)'}], 'secondaryOutcomes': [{'measure': 'Neutralizing antibody GMT of other SARS-CoV-2 variants', 'timeFrame': 'Until 12 months after vaccination', 'description': 'Neutralizing antibody GMT of Delta variant and Omicron variants (BA.2, BA.4, BA.5)'}, {'measure': 'Neutralizing antibody titer of other SARS-CoV-2 variants (MRNT)', 'timeFrame': 'Until 12 months after vaccination', 'description': 'Neutralizing antibody titer of Delta variant and Omicron variants (BA.2, BA.4, BA.5) by MRNT'}, {'measure': 'Neutralizing antibody titer of other SARS-CoV-2 variants (SVNT)', 'timeFrame': 'Until 12 months after vaccination', 'description': 'Neutralizing antibody titer of Delta variant and Omicron variants (BA.2, BA.4, BA.5) by SVNT'}, {'measure': 'Anti-SARS-CoV-2 receptor-binding domain (RBD) antibody level', 'timeFrame': 'Until 12 months after vaccination', 'description': 'Anti-SARS-CoV-2 RBD antibody level after vaccination'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID-19 Pandemic']}, 'descriptionModule': {'briefSummary': 'It is a single center, randomized, open-labeled, exploratory clinical study to evaluate the safety and immunogenicity of Recombinant SARS-CoV-2 Fusion Protein bivalent Vaccine V-01-B5 as a second booster in adults aged 18-59 years after vaccinated with 3-dose of inactivated vaccines.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '59 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged 18 -59 years old at time of consent, male or female;\n* Normal body temperature;\n* Participants who have completed 3-dose regimen of inactive vaccination (CoronaVac) against SARS-CoV-2 wild type in the past 5-9 months;\n* Female participants who are not pregnant at the time of enrollment (urine pregnancy test is negative), nor during lactating; and has no birth plan and agree to take effective contraception in 7 months after enrollment; and took effective and acceptable contraceptive methods in the previous 2 weeks before the enrollment;\n* Be able and willing to complete the study during the entire study and follow-up period;\n* Participants who have the ability to understand the study process, sign the informed consent form voluntarily , and be able to comply with the requirements of the clinical study protocol.\n\nExclusion Criteria:\n\n* Serious chronic diseases or uncontrolled diseases;\n* Uncontrolled neurological disorders, epilepsy;\n* Received any inactivated vaccine within 1 week or received any attenuated vaccines within 4 weeks;\n* Patients with congenital or acquired immunodeficiency;\n* History of severe allergy or be allergic to any components of the test vaccines;\n* History of hereditary hemorrhagic tendency or coagulation dysfunction;\n* Patients with malignant tumors and other patients have a life expectancy less than 1 year;\n* Refuse to sign the informed consent form or inability to complete follow-ups as required by the protocol;\n* History of previous COVID-19 infection;\n* Pregnant or breastfeeding women, or females of childbearing potential who not agree to or able to take effective and acceptable contraceptive methods during the study;\n* Participants who have participated in other clinical trials within 3 months or are participating in other clinical trials;\n* Those considered by the investigator as inappropriate to participate in the study.'}, 'identificationModule': {'nctId': 'NCT05585567', 'acronym': 'COVID-19', 'briefTitle': 'A Preliminary Exploratory Study to Evaluate the Safety and Immunogenicity of Omicron Variant Bivalent Vaccine V-01-B5', 'organization': {'class': 'INDUSTRY', 'fullName': 'Livzon Pharmaceutical Group Inc.'}, 'officialTitle': 'A Single Center, Randomized, Open-labeled, Exploratory Clinical Study to Evaluate the Safety and Immunogenicity of Bivalent Vaccine V-01-B5 as a Booster Dose in Participants Aged 18-59 Years Vaccinated 3-dose Inactivated COVID-19 Vaccine', 'orgStudyIdInfo': {'id': 'V-01-B5- Booster-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'V-01/V-01-B5 group', 'description': 'One dose of V-01/V-01-B5', 'interventionNames': ['Biological: V-01/V-01-B5']}, {'type': 'EXPERIMENTAL', 'label': 'V-01-351/V-01-B5 group', 'description': 'One dose of V-01-351/V-01-B5', 'interventionNames': ['Biological: V-01-351/V-01-B5']}, {'type': 'EXPERIMENTAL', 'label': 'V-01 group', 'description': 'One dose of V-01', 'interventionNames': ['Biological: V-01']}], 'interventions': [{'name': 'V-01/V-01-B5', 'type': 'BIOLOGICAL', 'description': 'Contains 10μg of V-01 and 10μg of V-01-B5', 'armGroupLabels': ['V-01/V-01-B5 group']}, {'name': 'V-01-351/V-01-B5', 'type': 'BIOLOGICAL', 'description': 'Contains 10μg of V-01-351 and 10μg of V-01-B5', 'armGroupLabels': ['V-01-351/V-01-B5 group']}, {'name': 'V-01', 'type': 'BIOLOGICAL', 'description': 'Contains 10μg of V-01', 'armGroupLabels': ['V-01 group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '512000', 'city': 'Shaoguan', 'state': 'Guangdong', 'country': 'China', 'facility': 'Shaoguan Hospital of Chinese Medicine', 'geoPoint': {'lat': 24.8, 'lon': 113.58333}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Livzon Pharmaceutical Group Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}