Ignite Creation Date:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2025-12-26 @ 7:09 PM
Study NCT ID:
NCT05150834
Status:
UNKNOWN
Last Update Posted:
2021-12-09
First Post:
2021-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gut Microbiota, the Potential Key to Modulating Humoral Immunogenicity of New Platform COVID-19 Vaccines
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 53}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-02-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-12-08', 'studyFirstSubmitDate': '2021-12-03', 'studyFirstSubmitQcDate': '2021-12-08', 'lastUpdatePostDateStruct': {'date': '2021-12-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Taxonomic biomarkers predicting immune responses', 'timeFrame': 'before the administration of first-dose', 'description': 'This study aimed to analyze whether fecal microbiota composition before vaccination was associated with immmune response level'}], 'secondaryOutcomes': [{'measure': 'Antibody titres after the first dose vaccination', 'timeFrame': '3weeks from the first-dose administration in BNT162b2 group, 8-12weeks from the first-dose administration in ChAdOx1', 'description': 'This study aimed to analyze maximum immune response after first dose vaccination'}, {'measure': 'Antibody titres after the second dose vaccination', 'timeFrame': '3 weeks from the second dose administration in both BNT162b2 and ChAdOx1 groups', 'description': 'This study aimed to analyze maximum immune response after second dose vaccination'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Microbiome', 'Vaccine', 'Covid-19', 'SARS-CoV-2', 'Immunogenicity']}, 'descriptionModule': {'briefSummary': 'Vaccination is the best way to mitigate the coronavirus disease 2019 (COVID-19) pandemic, but the vaccine immunogenicity may be quite variable from person to person. There is increasing evidence suggesting that the gut microbiome is a major determinant of vaccine immunogenicity. Thus, the investigators investigated the relationship between gut microbiota and humoral immune response after COVID-19 vaccination.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'From Febrary 25, 2021 to July 16, 2021, 53 healthy healthcare workers were prospectively recruited at a tertiary hospital in Seoul, Republic of Korea, and they were assigned to get either BNT162b2 (n=27) or ChAdOx1 (Oxford/AstraZeneca) (n=26) vaccines. Participants were excluded if they had history of medication which would affect gut microbiota in the past 1 month, including antibiotics, laxatives, and motility drugs; previous history of positive SARS-CoV-2 test on nasopharyngeal PCR; or positive serum Spike IgG results.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* People assigned to get either BNT162b2 or ChAdOx1 vaccines\n* informed concents\n\nExclusion Criteria:\n\n* Participants were excluded if they had a history of medication which would affect gut microbiota in the past 1 month, including antibiotics, laxatives, and motility drugs.'}, 'identificationModule': {'nctId': 'NCT05150834', 'briefTitle': 'Gut Microbiota, the Potential Key to Modulating Humoral Immunogenicity of New Platform COVID-19 Vaccines', 'organization': {'class': 'OTHER', 'fullName': 'Korea University Guro Hospital'}, 'officialTitle': 'Gut Microbiota, the Potential Key to Modulating Humoral Immunogenicity of New Platform COVID-19 Vaccines: Adenovirus-vectored Vaccine Versus mRNA Vaccine', 'orgStudyIdInfo': {'id': '2021GR0097'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ChAdOx1 vaccinated group', 'description': 'From Febrary 25, 2021 to July 16, 2021, healthy healthcare workers were prospectively recruited at a tertiary hospital in Seoul, Republic of Korea, and they were assigned to get ChAdOx1 (Oxford/AstraZeneca) (n=26) vaccines. Participants were excluded if they had history of medication which would affect gut microbiota in the past 1 month, including antibiotics, laxatives, and motility drugs; previous history of positive SARS-CoV-2 test on nasopharyngeal PCR; or positive serum Spike IgG results.', 'interventionNames': ['Other: This is observational study']}, {'label': 'BNT162b2 vaccinated group', 'description': 'From Febrary 25, 2021 to July 16, 2021, 53 healthy healthcare workers were prospectively recruited at a tertiary hospital in Seoul, Republic of Korea, and they were assigned to get BNT162b2 (n=27) vaccines. Participants were excluded if they had history of medication which would affect gut microbiota in the past 1 month, including antibiotics, laxatives, and motility drugs; previous history of positive SARS-CoV-2 test on nasopharyngeal PCR; or positive serum Spike IgG results.', 'interventionNames': ['Other: This is observational study']}], 'interventions': [{'name': 'This is observational study', 'type': 'OTHER', 'description': 'We enrolled the healthcare workers assigned to get either BNT162b2 or ChAdOx1 by the Korean government.', 'armGroupLabels': ['BNT162b2 vaccinated group', 'ChAdOx1 vaccinated group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08308', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Hye Seong, MD.PhD', 'role': 'CONTACT', 'email': 'msmjoonhoo@gmail.com', 'phone': '+82-10-4840-5965'}, {'name': 'Joon Young Song, MD.PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Hye Seong', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Koera University Guro Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Korea University Guro Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'clinical professor', 'investigatorFullName': 'Hye Seong', 'investigatorAffiliation': 'Korea University Guro Hospital'}}}}