Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2026-01-03 @ 10:20 PM
Study NCT ID:
NCT05315856
Status:
UNKNOWN
Last Update Posted:
2022-04-07
First Post:
2022-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reactogenicity, Immunogenicity and Inflammatory Response by New COVID-19 Vaccine Platforms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'blood sample'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'targetDuration': '24 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-06', 'studyFirstSubmitDate': '2022-03-29', 'studyFirstSubmitQcDate': '2022-04-06', 'lastUpdatePostDateStruct': {'date': '2022-04-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Immunoglobulin G (IgG) anti-S antibodies', 'timeFrame': 'At 3 weeks after the first-dose vaccination (T1)', 'description': 'measured using the Elecsys® Anti-SARS-CoV-2 S assay (Roche, Rotkreuz, Switzerland)'}, {'measure': 'Immunoglobulin G (IgG) anti-S antibodies', 'timeFrame': 'At 3 weeks after the second-dose vaccination (T2)', 'description': 'measured using the Elecsys® Anti-SARS-CoV-2 S assay (Roche, Rotkreuz, Switzerland)'}, {'measure': 'Neutralizing antibodies', 'timeFrame': 'At 3 weeks after the first-dose vaccination (T1)', 'description': 'Reduction in plaque count of 50% (PRNT50) was calculated for the median neutralizing titer (ND50) using the Spearman-Karber formula'}, {'measure': 'Neutralizing antibodies', 'timeFrame': 'At 3 weeks after the second-dose vaccination (T2)', 'description': 'Reduction in plaque count of 50% (PRNT50) was calculated for the median neutralizing titer (ND50) using the Spearman-Karber formula'}, {'measure': 'IL-6, TNF-α, and IL-1ß', 'timeFrame': 'At 3 days after the first dose', 'description': 'measured by flexible customized bead-based multiplex panels for Luminex assays (Human Premixed Multi-Analyte Kit, R\\&D Systems Inc., Minneapolis, MN, USA).'}, {'measure': 'IL-6, TNF-α, and IL-1ß', 'timeFrame': 'At 3 days after the second-dose', 'description': 'measured by flexible customized bead-based multiplex panels for Luminex assays (Human Premixed Multi-Analyte Kit, R\\&D Systems Inc., Minneapolis, MN, USA).'}, {'measure': 'reactogenicity after vaccination', 'timeFrame': 'Until post-vaccination day 7', 'description': 'Local erythema/swelling was regarded as positive sign if larger than 2.5 cm in diameter. Systemic adverse events were graded as follows: grade 0, no systemic adverse event; grade 1, any adverse event that did not interfere with activity; grade 2, any adverse event that interfered with daily activity. Fever was classified as grade 1 (from 37.5℃ to 38.4℃) and grade 2 (\\>38.5℃). Systemic adverse events were classified into two ways: (i) the highest level of severity of any adverse event reported by the participants and (ii) with or without specific adverse event.'}], 'secondaryOutcomes': [{'measure': 'The correlation between humoral immune response and reactogenicity after vaccination', 'timeFrame': 'The correlation between reactogenicity after the first dose and immunogenicity at T1 (3 weeks after dose 1 prior to dose 2) and T2 (3 weeks after dose 2);the correlation between reactogenicity after vaccine dose 2 and immunogenicity at T2', 'description': 'The correlation between humoral immune response and reactogenicity after vaccination'}, {'measure': 'The correlation between cytokine response and reactogenicity after vaccination', 'timeFrame': 'At 3 days after each dose', 'description': 'The correlation between cytokine response and reactogenicity after vaccination'}, {'measure': 'Long-term immunogenicity: Immunoglobulin G (IgG) anti-S antibodies', 'timeFrame': 'At 3 months after the second vaccination (T3)', 'description': 'measured using the Elecsys® Anti-SARS-CoV-2 S assay (Roche, Rotkreuz, Switzerland)'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['reactogenicity; immunogenicity'], 'conditions': ['COVID-19 Vaccination', 'Inflammation', 'Vaccine Immune Response', 'Vaccine Adverse Reaction']}, 'descriptionModule': {'briefSummary': 'Analysis of humoral antibody and cytokine kinetics after vaccination with either BNT162b2 or ChAdOx1 nCoV-19 vaccine and factors influencing the vaccine immunogenicity', 'detailedDescription': 'There is a different aspect of reactogenicity between BNT162b2 and ChAdOx1 nCoV-19 vaccine. Both new platform vaccines were concerned if they would elicit more significant local or systemic reactogenicity compared to the conventional vaccines. Previous studies had reported that immune cells such as mast cells and macrophages are activated just after vaccination, and release proinflammatory cytokines such as interleukin (IL)-6 and tumor necrosis factor (TNF)-α. The post-vaccination kinetics of inflammatory cytokines would be variable by each vaccine platform, and might be associated with reactogenicity. It is an interesting issue to be investigated whether the reactogenicity following newly developed BNT162b2 and ChAdOx1 would be associated with immunogenicity and inflammatory response or not. To better clarify these uncertainties, we evaluated the change of antibody response between BNT162b2 and ChAdOx1 over three months post-vaccination, in relation to the kinetics of inflammatory cytokines and reactogenicity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '59 Years', 'minimumAge': '19 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy young adults between the ages of 19 and 55 years who were willing to receive either BNT162b2 or ChAdOx1 were enrolled in the study and provided written informed consent', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Volunteers who provide the informed consent after either BNT162b2 or ChAdOx1 vaccination\n* healthy adults without underlying medical condition\n\nExclusion Criteria:\n\n* Volunteers who had ever infected with SARS-CoV2 were excluded.'}, 'identificationModule': {'nctId': 'NCT05315856', 'briefTitle': 'Reactogenicity, Immunogenicity and Inflammatory Response by New COVID-19 Vaccine Platforms', 'organization': {'class': 'OTHER', 'fullName': 'Korea University Guro Hospital'}, 'officialTitle': 'Different Significance of Reactogenicity in Immunogenicity and Inflammatory Response by New COVID-19 Vaccine Platforms: BNT162b2 mRNA Versus ChAdOx1 nCoV19 Vaccine', 'orgStudyIdInfo': {'id': '2021GR0099'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ChAdOx1 vaccine group', 'description': 'AstraZeneca vaccine (chimpanzee adenovirus-vectored vaccine, 0.5 mL \\[5 × 1010 viral particles\\] per dose)', 'interventionNames': ['Biological: either BNT162b2 or ChAdOx1 vaccine']}, {'label': 'BNT162b2 vaccine group', 'description': 'Pfizer-BioNTech vaccine (mRNA vaccine; 0.3 mL \\[30 μg\\] per dose)', 'interventionNames': ['Biological: either BNT162b2 or ChAdOx1 vaccine']}], 'interventions': [{'name': 'either BNT162b2 or ChAdOx1 vaccine', 'type': 'BIOLOGICAL', 'description': 'Either BNT162b2 or ChAdOx1 was assigned to each participant by the Korean governmental policy, not allowing personal choice. Sixty participants were vaccinated with two doses of the ChAdOx1 (AstraZeneca) at 12-week intervals, and the remaining sixty were immunized with the BNT162b2 (Pfizer-BioNTech) vaccine at 3-week interval.', 'armGroupLabels': ['BNT162b2 vaccine group', 'ChAdOx1 vaccine group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Suwon', 'state': 'Gyeonggi-do', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jung Yeon Heo', 'role': 'CONTACT', 'email': 'jyeon78@naver.com'}], 'facility': 'Ajou University School of Medicine', 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Yu Bin Seo', 'role': 'CONTACT'}], 'facility': 'Kangnam Sacred Heart Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Joon Young Song', 'role': 'CONTACT', 'email': 'infection@korea.ac.kr'}], 'facility': 'Korea University Guro Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Joon Young Song, MD', 'role': 'CONTACT', 'email': 'infection@korea.ac.kr', 'phone': '+82226263052'}, {'name': 'Jung Yeon Heo, MD', 'role': 'CONTACT', 'email': 'jyeon78@naver.com', 'phone': '+82312197818'}], 'overallOfficials': [{'name': 'Joon Young Song, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Korea University Guro Hospital'}, {'name': 'Jung Yeon Heo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ajou University School of Medicine'}, {'name': 'Yu Bin Seo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hallym University Kangnam Sacred Heart Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'We will make a decision after discussion with the staff of other hospitals. We will share data on adverse events and immunogenicity.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Korea University Guro Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ajou University School of Medicine', 'class': 'OTHER'}, {'name': 'Hallym University Kangnam Sacred Heart Hospital', 'class': 'OTHER'}, {'name': 'Korean Center for Disease Control and Prevention', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Joon Young Song', 'investigatorAffiliation': 'Korea University Guro Hospital'}}}}