Ignite Creation Date:
2025-12-24 @ 12:01 PM
Ignite Modification Date:
2026-02-25 @ 7:27 PM
Study NCT ID:
NCT02154061
Status:
COMPLETED
Last Update Posted:
2018-08-15
First Post:
2014-05-29
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Systems Biology of Flu Vaccine in Healthy Adults With and Without the Use of Antibiotics
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007251', 'term': 'Influenza, Human'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009976', 'term': 'Orthomyxoviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007252', 'term': 'Influenza Vaccines'}, {'id': 'D008795', 'term': 'Metronidazole'}, {'id': 'D009355', 'term': 'Neomycin'}, {'id': 'D014640', 'term': 'Vancomycin'}], 'ancestors': [{'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D009593', 'term': 'Nitroimidazoles'}, {'id': 'D009574', 'term': 'Nitro Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D006020', 'term': 'Glycopeptides'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'nroupha@emory.edu', 'phone': '404-712-1435', 'title': 'Nadine Rouphael, MD', 'organization': 'Emory University'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '365 days', 'eventGroups': [{'id': 'EG000', 'title': 'IIV Flu Vaccine With Antibiotics', 'description': 'This arm will receive antibiotics prior and after IIV administration.\n\nArm 1 and Arm 2: Inactivated Flu Vaccine: This is an FDA approved and tested Flu Vaccine.\n\nMetronidazole: This is a standard antibiotic\n\nNeomycin: This is a standard antibiotic.\n\nVancomycin: This is a standard antibiotic.', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 6, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'IIV Flu Vaccine', 'description': 'This arm will not take antibiotics in conjunction with IIV.\n\nArm 1 and Arm 2: Inactivated Flu Vaccine: This is an FDA approved and tested Flu Vaccine.', 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 3, 'seriousNumAtRisk': 17, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'anal itching', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'URI', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Four Fold Rise in HAI Titers or HAI 1:40 and Above in Each Group at D30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IIV Flu Vaccine With Antibiotics', 'description': 'This arm will receive antibiotics prior and after IIV administration.\n\nArm 1 and Arm 2: Inactivated Flu Vaccine: This is an FDA approved and tested Flu Vaccine.\n\nMetronidazole: This is a standard antibiotic\n\nNeomycin: This is a standard antibiotic.\n\nVancomycin: This is a standard antibiotic.'}, {'id': 'OG001', 'title': 'IIV Flu Vaccine', 'description': 'This arm will not take antibiotics in conjunction with IIV.\n\nArm 1 and Arm 2: Inactivated Flu Vaccine: This is an FDA approved and tested Flu Vaccine.'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At day 30', 'description': 'Number of participants with four fold rise in HAI titers or HAI 1:40 and above in each group at D30 will be recorded based on immunologic testing of blood samples', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Overall Number of Participants analyzed for "IIV Flu Vaccine with Antibiotics" is 15, as one participant received antibiotics and did not receive vaccine. The study personnel were unable to draw blood on her at the vaccination day- therefore she was part of the safety population and not the immunogenicity population.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'IIV Flu Vaccine With Antibiotics', 'description': 'This arm will receive antibiotics prior and after IIV administration.\n\nArm 1 and Arm 2: Inactivated Flu Vaccine: This is an FDA approved and tested Flu Vaccine.\n\nMetronidazole: This is a standard antibiotic\n\nNeomycin: This is a standard antibiotic.\n\nVancomycin: This is a standard antibiotic.'}, {'id': 'FG001', 'title': 'IIV Flu Vaccine', 'description': 'This arm will not take antibiotics in conjunction with IIV.\n\nArm 1 and Arm 2: Inactivated Flu Vaccine: This is an FDA approved and tested Flu Vaccine.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'enrolled but not vaccinated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'IIV Flu Vaccine With Antibiotics', 'description': 'This arm will receive antibiotics prior and after IIV administration.\n\nArm 1 and Arm 2: Inactivated Flu Vaccine: This is an FDA approved and tested Flu Vaccine.\n\nMetronidazole: This is a standard antibiotic\n\nNeomycin: This is a standard antibiotic.\n\nVancomycin: This is a standard antibiotic.'}, {'id': 'BG001', 'title': 'IIV Flu Vaccine', 'description': 'This arm will not take antibiotics in conjunction with IIV.\n\nArm 1 and Arm 2: Inactivated Flu Vaccine: This is an FDA approved and tested Flu Vaccine.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-05-13', 'size': 1142502, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-05-30T15:17', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2017-05-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-17', 'studyFirstSubmitDate': '2014-05-29', 'resultsFirstSubmitDate': '2018-05-30', 'studyFirstSubmitQcDate': '2014-05-30', 'lastUpdatePostDateStruct': {'date': '2018-08-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-05-30', 'studyFirstPostDateStruct': {'date': '2014-06-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-06-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-05-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Four Fold Rise in HAI Titers or HAI 1:40 and Above in Each Group at D30', 'timeFrame': 'At day 30', 'description': 'Number of participants with four fold rise in HAI titers or HAI 1:40 and above in each group at D30 will be recorded based on immunologic testing of blood samples'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Flu Vaccine, Intestinal Microbiome, Antibiotics'], 'conditions': ['Influenza']}, 'referencesModule': {'references': [{'pmid': '34174187', 'type': 'DERIVED', 'citation': 'Wimmers F, Donato M, Kuo A, Ashuach T, Gupta S, Li C, Dvorak M, Foecke MH, Chang SE, Hagan T, De Jong SE, Maecker HT, van der Most R, Cheung P, Cortese M, Bosinger SE, Davis M, Rouphael N, Subramaniam S, Yosef N, Utz PJ, Khatri P, Pulendran B. The single-cell epigenomic and transcriptional landscape of immunity to influenza vaccination. Cell. 2021 Jul 22;184(15):3915-3935.e21. doi: 10.1016/j.cell.2021.05.039. Epub 2021 Jun 25.'}]}, 'descriptionModule': {'briefSummary': "The purpose of the study is to better understand how the use of antibiotics changes micro-organisms in the intestines. The change to micro-organisms in the intestines may change the body's vaccine immune response and alter the effectiveness of the IIV (seasonal flu) vaccine.\n\nIn particular, the investigators will be looking at certain markers in blood after vaccination with IIV (seasonal flu vaccine) with or without the use of antibiotics before vaccination.\n\nThere will be two randomized groups. Group A will start taking antibiotic by mouth 3 days prior to vaccination and continue taking antibiotics the day of vaccination and one day after vaccination for a total of 5 days. Group B will only receive the IIV (seasonal flu vaccine) and will not take any antibiotics.\n\nThe investigators hope to enroll 50 subjects at Emory.", 'detailedDescription': 'We will study using a system biology approach the immune responses to IIV alone vs. IIV with antibiotic administration'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Healthy individuals aged 18-40 years.\n2. Able to understand and give informed consent.\n3. Women of child-bearing potential (not surgically sterile via tubal ligation, bilateral oophorectomy or hysterectomy or who are not postmenopausal for ≥1 year) must agree to practice adequate contraception that may include, but is not limited to, abstinence, monogamous relationship with vasectomized partner, barrier methods such as condoms, diaphragms, spermicides, intrauterine devices, and licensed hormonal methods for 30 days before and 30 days after TIV vaccination\n\nExclusion Criteria:\n\n* You received blood product within 3 months of enrolling in the study or a live attenuated vaccine within 4 weeks or inactivated vaccines within 2 weeks.\n* You received the 2014-2015 flu vaccine or had a confirmed case of influenza during 2014-2015.\n* You received any antibiotics 6 months prior to enrolling in the study or expect to take antibiotics one month after vaccination.\n* You received probiotics or prebiotics 3 months prior before enrolling in the study or expect to take one month after vaccination.\n* You received proton pump inhibitors, H2 blocker receptors, or antacids 3 months regularly before enrolling in the study or one month after\n* You had an allergic response or sensitivity to past vaccinations.\n* You have health conditions that weaken your body's ability to fight infections or you are taking drugs like steroids that weaken your body's ability to fight infections.(Some nasal and topical steroids are allowed.).\n* You have a chronic medical problem including (but not limited to) insulin dependent diabetes, severe heart disease including arrhythmias, severe lung disease, auto immune diseases and or grade 4 uncontrolled hypertension.\n* Chronic neurological conditions such as seizure disorder, Parkinson disease, myasthenia gravis, neuropathy, or histories of encephalopathy, meningitis or ototoxicity.\n* Any history of gastrointestinal disease, kidney or liver diseases.\n* Alcohol or drug abuse or psychiatric conditions that in the opinion of the investigator would compromise your participation in this trial.\n* Pregnant or are breast feeding."}, 'identificationModule': {'nctId': 'NCT02154061', 'acronym': 'VAX-002', 'briefTitle': 'Systems Biology of Flu Vaccine in Healthy Adults With and Without the Use of Antibiotics', 'organization': {'class': 'OTHER', 'fullName': 'Emory University'}, 'officialTitle': 'Systems Biology of Inactivated Influenza Vaccine (IIV) in Healthy Adults With or Without Use of Broad Spectrum Antibiotics', 'orgStudyIdInfo': {'id': 'IRB00074239'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IIV Flu Vaccine with Antibiotics', 'description': 'This arm will receive antibiotics prior and after IIV administration.', 'interventionNames': ['Drug: IIV Flu Vaccine', 'Drug: Metronidazole', 'Drug: Neomycin', 'Drug: Vancomycin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'IIV Flu Vaccine', 'description': 'This arm will not take antibiotics in conjunction with IIV.', 'interventionNames': ['Drug: IIV Flu Vaccine']}], 'interventions': [{'name': 'IIV Flu Vaccine', 'type': 'DRUG', 'otherNames': ['Fluzone'], 'description': 'This is an FDA approved and tested Inactivated Flu Vaccine.', 'armGroupLabels': ['IIV Flu Vaccine', 'IIV Flu Vaccine with Antibiotics']}, {'name': 'Metronidazole', 'type': 'DRUG', 'otherNames': ['Flagyl'], 'description': 'This is a standard antibiotic', 'armGroupLabels': ['IIV Flu Vaccine with Antibiotics']}, {'name': 'Neomycin', 'type': 'DRUG', 'description': 'This is a standard antibiotic.', 'armGroupLabels': ['IIV Flu Vaccine with Antibiotics']}, {'name': 'Vancomycin', 'type': 'DRUG', 'otherNames': ['Vancocin'], 'description': 'This is a standard antibiotic.', 'armGroupLabels': ['IIV Flu Vaccine with Antibiotics']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30030', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory Vaccine Center', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}], 'overallOfficials': [{'name': 'Nadine Rouphael, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emory University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emory University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Nadine Rouphael', 'investigatorAffiliation': 'Emory University'}}}}