Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-26 @ 4:27 AM
Study NCT ID:
NCT05067894
Status:
COMPLETED
Last Update Posted:
2022-08-09
First Post:
2021-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Immunogenicity of SARS-CoV-2 Protein Subunit Recombinant Vaccine
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': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Observer blind: Investigational Product and Active Comparator are masking. Lot number is masking'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-08-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-08', 'studyFirstSubmitDate': '2021-10-01', 'studyFirstSubmitQcDate': '2021-10-01', 'lastUpdatePostDateStruct': {'date': '2022-08-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety of the SARS-CoV-2 protein subunit recombinant vaccine within 7 days after each dose', 'timeFrame': '7 days after each dose', 'description': 'percentage of subjects with solicited and unsolicited Adverse Events (AE)'}], 'secondaryOutcomes': [{'measure': 'safety of the SARS-CoV-2 protein subunit recombinant vaccine within 28 days after each dose', 'timeFrame': '28 days after each dose', 'description': 'percentage of subjects with solicited and unsolicited AE'}, {'measure': 'Comparison of AE/ Serious Adverse Events (SAE) between intervention vaccine and active control', 'timeFrame': '28 days after each dose', 'description': 'percentage of subjects with AE and SAE between vaccine and active control group'}, {'measure': 'Deviation of laboratory evaluation', 'timeFrame': '28 days after the first dose', 'description': 'Any deviation from routine laboratory evaluation that probably related to the dosing'}, {'measure': 'Deviation of laboratory evaluation', 'timeFrame': '7 days after whole schedule dose', 'description': 'Any deviation from routine laboratory evaluation that probably related to the dosing'}, {'measure': 'Immunogenicity profile of the SARS-CoV-2 protein subunit recombinant vaccine after second dose', 'timeFrame': '28 days after each dose', 'description': 'seropositive rate, seroconversion rate and GMT of IgG antibody and neutralization antibody'}, {'measure': 'Comparison of immunogenicity between 2 and 3 doses', 'timeFrame': '28 days after second and third dose', 'description': 'seropositive rate, seroconversion rate and GMT of IgG antibody and neutralization antibody'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['covid19 vaccine'], 'conditions': ['Covid19']}, 'descriptionModule': {'briefSummary': 'The study is an observer-blind, randomized, controlled prospective intervention study of Phase I. The primary objective is To evaluate the safety of the SARS-CoV-2 protein subunit recombinant vaccine within 7 days after each dose.', 'detailedDescription': 'This trial is observer blinded, comparative, randomized, phase I study. Approximately 60 subjects will be recruited (18 years and above).\n\nThe investigational product is 0.5 ml in three dose-regimen (for all subjects) with 28 days apart between doses, compare to an active control (inactivated SARS-CoV-2 vaccine)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Clinically healthy subjects within the following age groups: adults (18-59 years) and elderly (60 years and above.\n2. Subjects have been informed properly regarding the study and signed the informed consent form.\n3. Subjects will commit to comply with the instructions of the investigator and the schedule of the trial.\n\nExclusion Criteria:\n\n1. Subjects concomitantly enrolled or scheduled to be enrolled in another trial.\n2. History of vaccination with any investigational product against Covid-19 during or 6 months prior to enrollment.\n3. Subjects who have history of Covid-19 in the last 3 months (based on anamnesis or other examinations).\n4. Evolving mild, moderate or severe illness, especially infectious disease or fever (body temperature ≥37.5℃, measured with infrared thermometer/thermal gun).\n5. The result of rapid antigen test is positive.\n6. Women who are lactating, pregnant or planning to become pregnant during the study period (judged by self-report of subjects and urine pregnancy test results).\n7. Abnormality hematology and biochemical test results.\n8. History of asthma, history of allergy to vaccines or vaccine ingredients, and severe adverse reactions to vaccines, such as urticaria, dyspnea, and angioneurotic edema.\n9. History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection.\n10. Patients with serious chronic diseases (serious cardiovascular diseases, uncontrolled hypertension and diabetes, liver and kidney diseases, malignant tumors, etc) which according to the investigator might interfere with the assessment of the trial objectives.\n11. Subjects who have any history of confirmed or suspected immunosuppressive or immunodeficient state, or received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products or long-term corticosteroid therapy (\\> 2 weeks)).\n12. Subjects who have history of uncontrolled epilepsy or other progressive neurological disorders, such as Guillain-Barre Syndrome.\n13. Subjects receive any vaccination (other than Covid-19 vaccine) within 1 month before and after Investigational Product (IP) immunization.\n14. Subjects plan to move from the study area before the end of study period.'}, 'identificationModule': {'nctId': 'NCT05067894', 'briefTitle': 'Safety and Immunogenicity of SARS-CoV-2 Protein Subunit Recombinant Vaccine', 'organization': {'class': 'INDUSTRY', 'fullName': 'PT Bio Farma'}, 'officialTitle': 'A Phase I, Observer-Blind, Randomized, Controlled Study of the Safety and Immunogenicity of SARS-CoV-2 Protein Subunit Recombinant Vaccine in Healthy Populations Aged 18 Years and Above in Indonesia', 'orgStudyIdInfo': {'id': 'CoV2-010221'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Adult - Vaccine candidate', 'description': '50 µg dose, adult group (18-59 years)', 'interventionNames': ['Biological: SARS-CoV-2 Protein Subunit Recombinant Vaccine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Adult - Control', 'description': 'SARS-CoV-2 inactivated vaccine, adult group (18-59 years)', 'interventionNames': ['Biological: SARS-CoV-2 Inactivated Vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'Elderly - Vaccine candidate', 'description': '50 µg dose, elderly group (\\> 60 years)', 'interventionNames': ['Biological: SARS-CoV-2 Protein Subunit Recombinant Vaccine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Elderly - Control', 'description': 'SARS-CoV-2 inactivated vaccine, elderly group (\\> 60 years)', 'interventionNames': ['Biological: SARS-CoV-2 Inactivated Vaccine']}], 'interventions': [{'name': 'SARS-CoV-2 Protein Subunit Recombinant Vaccine', 'type': 'BIOLOGICAL', 'description': 'intramuscular injection', 'armGroupLabels': ['Adult - Vaccine candidate', 'Elderly - Vaccine candidate']}, {'name': 'SARS-CoV-2 Inactivated Vaccine', 'type': 'BIOLOGICAL', 'description': 'intramuscular injection', 'armGroupLabels': ['Adult - Control', 'Elderly - Control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jakarta', 'state': 'Greater Jakarta', 'country': 'Indonesia', 'facility': 'Fakultas Kedokteran Universitas Indonesia', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}], 'overallOfficials': [{'name': 'Prof. Rini Sekartini, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fakultas Kedokteran Universitas Indonesia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PT Bio Farma', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Fakultas Kedokteran Universitas Indonesia', 'class': 'OTHER'}, {'name': 'National Institute of Health Research and Development, Ministry of Health Republic of Indonesia', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}