Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-26 @ 3:01 AM
Study NCT ID:
NCT04640402
Status:
COMPLETED
Last Update Posted:
2022-06-01
First Post:
2020-11-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Phase Ⅱ Clinical Trial of Recombinant Corona Virus Disease-19 (COVID-19) Vaccine (Sf9 Cells)
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002985', 'term': 'Clinical Protocols'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D016020', 'term': 'Epidemiologic Study Characteristics'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 960}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2021-11-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-31', 'studyFirstSubmitDate': '2020-11-19', 'studyFirstSubmitQcDate': '2020-11-20', 'lastUpdatePostDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'The consistency analysis of the specific antibody and the specific neutralizing antibody', 'timeFrame': '1 months after immunization in each study group', 'description': 'The consistency analysis of the specific antibody (ELISA) and the specific neutralizing antibody (euvirus and pseudovirus neutralization assays) against SARS-CoV-2 S-RBD protein'}, {'measure': 'The geometric mean titer (GMT) ratio of the SARS-CoV-2 neutralizing antibody and the S-RBD protein specific antibody', 'timeFrame': '1 months after immunization in each study group', 'description': 'The geometric mean titer (GMT) ratio of the SARS-CoV-2 neutralizing antibody and the S-RBD protein specific antibody in each study groups'}, {'measure': 'The persistence (GMT，GMI，positive conversion rate) of specific antibodies', 'timeFrame': '6 months after vaccination in each study group', 'description': 'The persistence (GMT，GMI，positive conversion rate) of specific antibodies against SARS-CoV-2 S-RBD protein'}, {'measure': 'Subtypes of immunoglobulin G (IgG) antibodies', 'timeFrame': '1 months after immunization in each study group', 'description': 'Subtypes of IgG antibodies against the S-RBD protein of SARS-CoV-2 after immunization in each study group'}], 'primaryOutcomes': [{'measure': 'Geometric mean (GMT) of specific antibody', 'timeFrame': '1 months after immunization in each study group', 'description': 'Geometric mean (GMT) of specific antibody against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Spike protein Receptor-binding domain(S-RBD) protein (ELISA)'}, {'measure': 'The incidence of adverse reaction (AR)', 'timeFrame': '0 to 7 days after vaccination in each study group', 'description': 'The incidence of adverse reaction (AR)'}], 'secondaryOutcomes': [{'measure': 'The incidence of adverse events (AE)', 'timeFrame': '0 to 28 days after vaccination in each study group', 'description': 'The incidence of adverse events (AE)'}, {'measure': 'The incidence of severe adverse events (SAE)', 'timeFrame': '0 to 28 days after vaccination in each study group', 'description': 'The incidence of severe adverse events (SAE)'}, {'measure': 'The incidence of serious adverse events', 'timeFrame': '6 months after vaccination in each study group', 'description': 'The incidence of serious adverse events'}, {'measure': 'Geometric mean (GMT) of anti-SARS-CoV-2-specific neutralizing antibodies', 'timeFrame': '1 months after immunization in each study group', 'description': 'Geometric mean (GMT) of anti-SARS-CoV-2-specific neutralizing antibodies (euvirus and pseudovirus-neutralizing assays)'}, {'measure': 'The positive conversion rate of S-RBD protein-specific antibody', 'timeFrame': '14 days, 30 days after immunization in each study group', 'description': 'The positive conversion rate of S-RBD protein-specific antibody (ELISA) against SARS-CoV-2'}, {'measure': 'Geometric mean fold increase (GMI) of S-RBD protein-specific antibody', 'timeFrame': '14 days, 30 days after immunization in each study group', 'description': 'Geometric mean fold increase (GMI) of S-RBD protein-specific antibody (ELISA) against SARS-CoV-2'}, {'measure': 'Geometric mean (GMT) of anti-SARS-CoV-2-specific neutralizing antibodies', 'timeFrame': '14 days after immunization in each study group', 'description': 'Geometric mean (GMT) of anti-SARS-CoV-2-specific neutralizing antibodies (euvirus and pseudovirus-neutralizing assays)'}, {'measure': 'The positive conversion rate of anti-SARS-CoV-2 specific neutralizing antibody', 'timeFrame': '14 days, 30 days after immunization in each study group', 'description': 'The positive conversion rate of anti-SARS-CoV-2 specific neutralizing antibody (euvirus and pseudovirus neutralization test)'}, {'measure': 'Geometric mean fold increase (GMI) of anti-SARS-CoV-2 specific neutralizing antibodies', 'timeFrame': '14 days, 30 days after immunization in each study group', 'description': 'Geometric mean fold increase (GMI) of anti-SARS-CoV-2 specific neutralizing antibodies (eucivirus and pseudovirus neutralization assays)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Safety', 'Immunogenicity', 'COVID-19 Vaccine', 'Recombinant vaccine'], 'conditions': ['COVID-19']}, 'descriptionModule': {'briefSummary': 'This is a phase Ⅱ, single-center, randomized, double-blind, placebo-controlled study, to evaluate the immunogenicity and safety of the recombinant COVID-19 vaccine (Sf9 cells) in the subjects from healthy adults and elderly adults aged 18 years and above (aged 18-60 and 60-85 years) with different immunization procedures (0, 21 days and 0, 14, 28 days) and doses (20μg/40μg).', 'detailedDescription': 'This is a phase Ⅱ, single-center, randomized, double-blind, placebo-controlled study, to evaluate the immunogenicity and safety of the recombinant COVID-19 vaccine (Sf9 cells) in the subjects from healthy adults and elderly adults aged 18 years and above (aged 18-60 and 60-85 years) . The phase Ⅱ clinical trials designed 8 research group, including two immunization procedures (0, 21 days and 0, 14, 28 days), two doses (20μg/0.5ml, 40μg/1.0ml) and two ages group (adults and elder): Each group including 120 participants. Vaccination or placebo group will be randomly assigned to receive in a 5:1 ratio, 960 in total.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18 years and above.\n* Able to understand the content of informed consent and willing to sign the informed consent.\n* Able and willing to complete all the secluded study process during the whole study follow-up period (about 7 months).\n* Axillary temperature ≤37.0℃.\n* General good health as established by medical history and physical examination.\n\nExclusion Criteria:\n\nFirst dose exclusion criteria:\n\n* Positive serum immunoglobulin M (IgM) and IgG to the SARS-CoV-2.\n* A Known History of HIV infection\n* Family history of seizure, epilepsy, brain or mental disease.\n* Participant that has an allergic history to any ingredient of vaccines.\n* Woman who is pregnant, breast-feeding or positive in pregnancy test on day of enrollment, or is planning to be pregnant during the next 6 months.\n* Any acute fever disease or infections.\n* Have a medical history of SARS.\n* Have serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, severe hypertension and not well-controlled.\n* Major chronic illness, such as asthma, diabetes, or thyroid disease, and not well-controlled.\n* Hereditary angioneurotic edema or acquired angioneurotic edema.\n* Urticaria in last one year.\n* Asplenia or functional asplenia.\n* Platelet disorder or other bleeding disorder may cause injection contraindication.\n* Faint at the sight of blood or needles.\n* Prior administration of immunodepressant or corticosteroids, antianaphylactics treatment, cytotoxic treatment in last 6 months.\n* Prior administration of blood products in last 4 months.\n* Prior administration of other research medicines in last 1 month.\n* Prior administration of attenuated vaccine in last 1 month.\n* Prior administration of subunit vaccine or inactivated vaccine in last 14 days.\n* Being treated for tuberculosis.\n* Any condition that in the opinion of the investigators may interfere with the evaluation of study objectives.\n\nExclusion criteria for subsequent doses:\n\n* Patients with severe allergic reactions after the previous dose of vaccination;\n* Patients with serious adverse events causally related to the previous dose of vaccination.'}, 'identificationModule': {'nctId': 'NCT04640402', 'briefTitle': 'A Phase Ⅱ Clinical Trial of Recombinant Corona Virus Disease-19 (COVID-19) Vaccine (Sf9 Cells)', 'organization': {'class': 'NETWORK', 'fullName': 'Jiangsu Province Centers for Disease Control and Prevention'}, 'officialTitle': 'A Single-center, Randomized, Double-Blinded, Placebo-Controlled, Phase Ⅱ Clinical Trial of Recombinant COVID-19 Vaccine (Sf9 Cells), in the Subjects From Healthy Aged 18 Years and Above', 'orgStudyIdInfo': {'id': 'JSVCT099'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low-dose vaccine (18-59 years) & Two dose regimen', 'description': 'two doses of low-dose Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21.', 'interventionNames': ['Biological: Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Two dose regimen']}, {'type': 'EXPERIMENTAL', 'label': 'Low-dose vaccine (18-59 years) & Three dose regimen', 'description': 'three doses of low-dose Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 14, 28.', 'interventionNames': ['Biological: Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Three dose regimen']}, {'type': 'EXPERIMENTAL', 'label': 'High-dose vaccine (18-59 years) & Two dose regimen', 'description': 'two doses of high-dose Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21.', 'interventionNames': ['Biological: High-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Two dose regimen']}, {'type': 'EXPERIMENTAL', 'label': 'High-dose vaccine (18-59 years) & Three dose regimen', 'description': 'three doses of high-dose Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 14, 28.', 'interventionNames': ['Biological: High-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Three dose regimen']}, {'type': 'EXPERIMENTAL', 'label': 'Low-dose vaccine (60-85 years) & Two dose regimen', 'description': 'two doses of low-dose Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21.', 'interventionNames': ['Biological: Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Two dose regimen']}, {'type': 'EXPERIMENTAL', 'label': 'Low-dose vaccine (60-85 years) & Three dose regimen', 'description': 'three doses of low-dose Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 14, 28.', 'interventionNames': ['Biological: Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Three dose regimen']}, {'type': 'EXPERIMENTAL', 'label': 'High-dose vaccine (60-85 years) & Two dose regimen', 'description': 'two doses of high-dose Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21.', 'interventionNames': ['Biological: High-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Two dose regimen']}, {'type': 'EXPERIMENTAL', 'label': 'High-dose vaccine (60-85 years) & Three dose regimen', 'description': 'three doses of high-dose Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 14, 28.', 'interventionNames': ['Biological: High-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Three dose regimen']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Low-dose placebo (18-59 years) & Two dose regimen', 'description': 'two doses of placebo at the schedule of day 0, 21.', 'interventionNames': ['Biological: Low-dose placebo (18-59 years) & Two dose regimen']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Low-dose placebo (18-59 years) & Three dose regimen', 'description': 'three doses of placebo at the schedule of day 0, 14, 28.', 'interventionNames': ['Biological: Low-dose placebo (18-59 years) & Three dose regimen']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'High-dose placebo (18-59 years) & Two dose regimen', 'description': 'two doses of placebo at the schedule of day 0, 21.', 'interventionNames': ['Biological: High-dose placebo (18-59 years) & Two dose regimen']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'High-dose placebo (18-59 years) & Three dose regimen', 'description': 'three doses of placebo at the schedule of day 0, 14, 28.', 'interventionNames': ['Biological: High-dose placebo (18-59 years) & Three dose regimen']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Low-dose placebo (60-85 years) & Two dose regimen', 'description': 'two doses of placebo at the schedule of day 0, 21.', 'interventionNames': ['Biological: Low-dose placebo (60-85 years) & Two dose regimen']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Low-dose placebo (60-85 years) & Three dose regimen', 'description': 'three doses of placebo at the schedule of day 0, 14, 28.', 'interventionNames': ['Biological: Low-dose placebo (60-85 years) & Three dose regimen']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'High-dose placebo (60-85 years) & Two dose regimen', 'description': 'two doses of placebo at the schedule of day 0, 21.', 'interventionNames': ['Biological: High-dose placebo (60-85 years) & Two dose regimen']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'High-dose placebo (60-85 years) & Three dose regimen', 'description': 'three doses of placebo at the schedule of day 0, 14, 28.', 'interventionNames': ['Biological: High-dose placebo (60-85 years) & Three dose regimen']}], 'interventions': [{'name': 'Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Two dose regimen', 'type': 'BIOLOGICAL', 'description': '18-59 years group, two doses of low-dose (20µg/0.5ml) Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21.', 'armGroupLabels': ['Low-dose vaccine (18-59 years) & Two dose regimen']}, {'name': 'Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Three dose regimen', 'type': 'BIOLOGICAL', 'description': '18-59 years group, three doses of low-dose (20µg/0.5ml) Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 14, 28.', 'armGroupLabels': ['Low-dose vaccine (18-59 years) & Three dose regimen']}, {'name': 'High-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Two dose regimen', 'type': 'BIOLOGICAL', 'description': '18-59 years group, two doses of high-dose (40µg/1.0ml) Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21.', 'armGroupLabels': ['High-dose vaccine (18-59 years) & Two dose regimen']}, {'name': 'High-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Three dose regimen', 'type': 'BIOLOGICAL', 'description': '18-59 years group, three doses of high-dose (40µg/1.0ml) Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 14, 28.', 'armGroupLabels': ['High-dose vaccine (18-59 years) & Three dose regimen']}, {'name': 'Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Two dose regimen', 'type': 'BIOLOGICAL', 'description': '60-85 years group, two doses of low-dose (20µg/0.5ml) Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21.', 'armGroupLabels': ['Low-dose vaccine (60-85 years) & Two dose regimen']}, {'name': 'Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Three dose regimen', 'type': 'BIOLOGICAL', 'description': '60-85 years group, three doses of low-dose (20µg/0.5ml) Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 14, 28.', 'armGroupLabels': ['Low-dose vaccine (60-85 years) & Three dose regimen']}, {'name': 'High-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Two dose regimen', 'type': 'BIOLOGICAL', 'description': '60-85 years group, two doses of high-dose (40µg/1.0ml) Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21.', 'armGroupLabels': ['High-dose vaccine (60-85 years) & Two dose regimen']}, {'name': 'High-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Three dose regimen', 'type': 'BIOLOGICAL', 'description': '60-85 years group, three doses of high-dose (40µg/1.0ml) Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 14, 28.', 'armGroupLabels': ['High-dose vaccine (60-85 years) & Three dose regimen']}, {'name': 'Low-dose placebo (18-59 years) & Two dose regimen', 'type': 'BIOLOGICAL', 'description': '18-59 years group, two doses of placebo(0.5ml) at the schedule of day 0, 21.', 'armGroupLabels': ['Low-dose placebo (18-59 years) & Two dose regimen']}, {'name': 'Low-dose placebo (18-59 years) & Three dose regimen', 'type': 'BIOLOGICAL', 'description': '18-59 years group, three doses of placebo(0.5ml) at the schedule of day 0, 14, 28.', 'armGroupLabels': ['Low-dose placebo (18-59 years) & Three dose regimen']}, {'name': 'High-dose placebo (18-59 years) & Two dose regimen', 'type': 'BIOLOGICAL', 'description': '18-59 years group, two doses of placebo(1.0ml) at the schedule of day 0, 21.', 'armGroupLabels': ['High-dose placebo (18-59 years) & Two dose regimen']}, {'name': 'High-dose placebo (18-59 years) & Three dose regimen', 'type': 'BIOLOGICAL', 'description': '18-59 years group, three doses of placebo(1.0ml) at the schedule of day 0, 14, 28.', 'armGroupLabels': ['High-dose placebo (18-59 years) & Three dose regimen']}, {'name': 'Low-dose placebo (60-85 years) & Two dose regimen', 'type': 'BIOLOGICAL', 'description': '60-85 years group, two doses of placebo(0.5ml) at the schedule of day 0, 21.', 'armGroupLabels': ['Low-dose placebo (60-85 years) & Two dose regimen']}, {'name': 'Low-dose placebo (60-85 years) & Three dose regimen', 'type': 'BIOLOGICAL', 'description': '60-85 years group, three doses of placebo(0.5ml) at the schedule of day 0, 14, 28.', 'armGroupLabels': ['Low-dose placebo (60-85 years) & Three dose regimen']}, {'name': 'High-dose placebo (60-85 years) & Two dose regimen', 'type': 'BIOLOGICAL', 'description': '60-85 years group, two doses of placebo(1.0ml) at the schedule of day 0, 21.', 'armGroupLabels': ['High-dose placebo (60-85 years) & Two dose regimen']}, {'name': 'High-dose placebo (60-85 years) & Three dose regimen', 'type': 'BIOLOGICAL', 'description': '60-85 years group, three doses of placebo(1.0ml) at the schedule of day 0, 14, 28.', 'armGroupLabels': ['High-dose placebo (60-85 years) & Three dose regimen']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210009', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Jiangsu Provincial Center for Diseases Control and Prevention', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'overallOfficials': [{'name': 'Fengcai Zhu, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jiangsu Provincial Center for Disease Control and Prevention'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jiangsu Province Centers for Disease Control and Prevention', 'class': 'NETWORK'}, 'collaborators': [{'name': 'West China Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}