Ignite Creation Date:
2025-12-24 @ 9:45 PM
Ignite Modification Date:
2026-01-01 @ 6:41 PM
Study NCT ID:
NCT05165732
Status:
SUSPENDED
Last Update Posted:
2022-08-11
First Post:
2021-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Immunogenicity Study of Booster Vaccination With COVID-19 Vaccine (Vero Cell),Inactivated From Different Manufactures for Prevention of COVID-19
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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 480}}, 'statusModule': {'whyStopped': 'Limited subjects', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2022-12-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2023-08-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-09', 'studyFirstSubmitDate': '2021-12-20', 'studyFirstSubmitQcDate': '2021-12-20', 'lastUpdatePostDateStruct': {'date': '2022-08-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Immunogenicity index-GMT of neutralizing antibodies', 'timeFrame': '28 days after booster dose', 'description': 'GMT of neutralizing antibody 28 days after booster dose.'}, {'measure': 'Immunogenicity index-seroconversion rate (4-fold and above increase)of neutralizing antibodies', 'timeFrame': '28 days after booster dose', 'description': 'Seroconversion rate (4-fold and above increase)of neutralizing antibodies 28 days after booster dose.'}, {'measure': 'Immunogenicity index-seropositive rate of neutralizing antibody', 'timeFrame': '28 days after booster dose', 'description': 'Seropositive rate of neutralizing antibody 28 days after booster dose.'}], 'secondaryOutcomes': [{'measure': 'Safety index-Incidence of adverse reactions', 'timeFrame': '0-28 days after booster', 'description': 'Incidence of adverse reactions occured 0-28 days after booster'}, {'measure': 'Safety index-Incidence of adverse reactions', 'timeFrame': '0-7 days after booster dose', 'description': 'Incidence of adverse reactions occurred 0-7 days after booster dose.'}, {'measure': 'Safety index-Incidence of SAEs and AESIs', 'timeFrame': '0-28 days after booster', 'description': 'Incidence of SAEs and AESIs occured 0-28 days after booster.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID-19']}, 'descriptionModule': {'briefSummary': 'This is a randomized, Open, control phase Ⅳ clinical trial of inactivated COVID-19 vaccine manufactured by Sinovac Research \\& Development Co., Ltd,Beijing institute of Biological Products Co.,Ltd and Wuhan Institute of Biological Products Co.,Ltd.The purpose of this study is to explore booster Immunization of SARS-CoV-2 Inactivated Vaccine from different manufactures in adults aged 18-45 years old Previously Vaccinated with inactivated COVID-19 vaccine', 'detailedDescription': 'This study a randomized, Open, control phase Ⅳclinical trial of inactivated COVID-19 vaccine .The purpose of this study is to explore booster Immunization of SARS-CoV-2 inactivated vaccine from different manufactures in adults aged 18-45 years old previously vaccinated with inactivated COVID-19 vaccine.A total of 480 subjects who have completed vaccination of two doses of inactivated COVID-19 vaccine for 6 to 8 months will be enrolled.In this study ,96 subjects who completed primary immunization with inactivated COVID-19 vaccine manufactured by Sinovac Research \\& Development Co.,Ltd. will receive one dose of booster immunization with inactivated COVID-19 vaccine manufactured by Sinovac Research \\& Development Co.,Ltd.(experimental group 1).192 subjects who completed primary immunization with inactivated COVID-19 vaccine manufactured by Beijing institute of Biological Products Co.,Ltd. will be randomly divided into two groups (experimental group 2 and experimental group 3) in a 1:1 ratio and receive one dose of booster immunization with inactivated COVID-19 vaccine manufactured by Sinovac Research \\& Development Co.,Ltd. and Beijing institute of Biological Products Co., Ltd,respectively.192 subjects who completed primary immunization with inactivated COVID-19 vaccine manufactured by Wuhan Institute of Biological Products Co.,Ltd.will be randomly divided into two groups(experimental group 4 and experimental group 5) in a 1:1 ratio and receive one dose of booster immunization with inactivated COVID-19 vaccine manufactured by Sinovac Research \\& Development Co.,Ltd. and Wuhan Institute of Biological Products Co.,Ltd.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adults aged 18-45;\n* Proven legal identity;\n* The subjects can understand and voluntarily sign the informed consent form and be willing to complete the study in accordance with the study plan;\n* Have completed two doses of SARS-CoV-2 inactivated vaccine vaccination for 6 to 8 months(the interval between the two doses vaccine of primary immunization is 21\\~35 days, and the two doses vaccine of primary immunization should be manufactured by the same manufactures).\n\nExclusion Criteria:\n\n* History of SARS-CoV-2 infection(laboratory confirmed);\n* Have received inactivated SARS-CoV-2 vaccine from other manufacturers other than Sinovac Life Sciences Co., Ltd.,Beijing Institute of Biological Products Co.,Ltd.and Wuhan Institute of Biological Products Co.,Ltd.and received three and more doses of inactivated SARS-CoV-2 vaccine;\n* Severe adverse reactions, such as urticaria, dyspnea, and angioneurotic edema , occurred during the primary immunization;\n* Autoimmune disease such as systemic lupus erythematosus or immunodeficiency / immunosuppression such as AIDS, post-transplant;\n* Severe chronic diseases, severe cardiovascular diseases, hypertension and diabetes that cannot be controlled by drugs, liver or kidney diseases, malignant tumors, etc;\n* Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness;\n* Diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy, abnormal platelets) or obvious bruising or blood coagulation;\n* Immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids(excluding allergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitis superficial corticosteroid therapy) in the past 6 months;\n* History of alcohol or drug abuse;\n* Receipt of blood products within in the past 3 months;\n* Receipt of other investigational drugs in the past 30 days;\n* Receipt of other investigational drugs in the past 30 days;\n* Receipt of attenuated live vaccines in the past 14 days;\n* Acute diseases or acute exacerbation of chronic diseases within 7 days prior to booster vaccination;\n* Axillary temperature \\>37.0°C;\n* Already pregnant or are breastfeeding, planning to get pregnant within\n\n 1months (according to subjects' self-report and urine pregnancy test results);\n* Participated in other clinical trials prior to enrollment and during the followup period, or planned to participate in other clinical trials during the clinical trial period;\n* According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial."}, 'identificationModule': {'nctId': 'NCT05165732', 'briefTitle': 'Safety and Immunogenicity Study of Booster Vaccination With COVID-19 Vaccine (Vero Cell),Inactivated From Different Manufactures for Prevention of COVID-19', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sinovac Biotech Co., Ltd'}, 'officialTitle': 'A Randomized, Open, Control Phase ⅠV Clinical Trial, to Evaluate One Booster Immunization of Inactivated COVID-19 Vaccine (CoronaVac) or Original Vaccine in Adults Aged 18-45 Years Old Previously Vaccinated With Inactivated COVID-19 Vaccine From Difference Manufactures', 'orgStudyIdInfo': {'id': 'PRO-nCOV-4012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Group 1', 'description': '96 subjects who completed primary immunization with inactivated COVID-19 vaccine manufactured by Sinovac Research \\& Development Co.,Ltd. will receive one dose of booster immunization with inactivated COVID-19 vaccine manufactured by Sinovac Research \\& Development Co.,Ltd.', 'interventionNames': ['Biological: Experimental vaccine 1']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental Group 2', 'description': '96 subjects who completed primary immunization with inactivated COVID-19 vaccine manufactured by Beijing institute of Biological Products Co,Ltd. will receive one dose of booster immunization with inactivated COVID-19 vaccine manufactured by Sinovac Research \\& Development Co.,Ltd.', 'interventionNames': ['Biological: Experimental vaccine 1']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental Group 3', 'description': '96 subjects who completed primary immunization with inactivated COVID-19 vaccine manufactured by Beijing institute of Biological Products Co.,Ltd. will receive one dose of booster immunization with inactivated COVID-19 vaccine manufactured by Beijing institute of Biological Products Co.,Ltd.', 'interventionNames': ['Biological: Experimental vaccine 2']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental Group 4', 'description': '92 subjects who completed primary immunization with inactivated COVID-19 vaccine manufactured by Wuhan Institute of Biological Products Co.,Ltd will receive one dose of booster immunization with inactivated COVID-19 vaccine manufactured by Sinovac Research \\& Development Co.,Ltd.', 'interventionNames': ['Biological: Experimental vaccine 1']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental Group 5', 'description': '92 subjects who completed primary immunization with inactivated COVID-19 vaccine manufactured by Wuhan Institute of Biological Products Co.,Ltd will receive one dose of booster immunization with inactivated COVID-19 vaccine manufactured by Wuhan Institute of Biological Products Co.,Ltd.', 'interventionNames': ['Biological: Experimental vaccine 3']}], 'interventions': [{'name': 'Experimental vaccine 1', 'type': 'BIOLOGICAL', 'description': 'Inactivated COVID-19 vaccine manufactured by Sinovac Life Sciences Co., Ltd.600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection.', 'armGroupLabels': ['Experimental Group 1', 'Experimental Group 2', 'Experimental Group 4']}, {'name': 'Experimental vaccine 2', 'type': 'BIOLOGICAL', 'description': 'Inactivated COVID-19 vaccine manufactured by Beijing Institute of Biological Products Co.,Ltd.4ug inactivated virus in 0.5 mL of aluminium hydroxide solution per injection.', 'armGroupLabels': ['Experimental Group 3']}, {'name': 'Experimental vaccine 3', 'type': 'BIOLOGICAL', 'description': 'Inactivated COVID-19 vaccine manufactured by Wuhan Institute of Biological Products Co.,Ltd.200WU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection.', 'armGroupLabels': ['Experimental Group 5']}]}, 'contactsLocationsModule': {'locations': [{'zip': '565300', 'city': 'Tongren', 'state': 'Guizhou', 'country': 'China', 'facility': 'Yanhe Tujia Autonomous County Center for Disease Control and Prevention', 'geoPoint': {'lat': 27.71722, 'lon': 109.18528}}], 'overallOfficials': [{'name': 'Qiuyue Mu, Master', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Guizhou Provincial Center for Disease Prevention and Control'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sinovac Research and Development Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}