[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100339905":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":13,"studyPopulation":13,"armGroups":21,"interventions":37,"overallOfficials":13,"centralContacts":51,"locations":57,"responsibleParty":76,"collaborators":13,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":13,"eligibilityCriteria":86,"healthyVolunteers":87,"sex":88,"minAge":89,"maxAge":13,"enrollmentInfo":90,"targetDuration":13,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":13,"overallStatus":60,"whyStopped":13,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"University of Maryland, Baltimore","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Percentage of Responders","Percentage of responders by cytokine production (Interferon-gamma (IFN-gamma) or Tumor Necrosis Factor-alpha (TNF-α)) by mass cytometry or flow cytometry. Responders will be defined as those volunteers showing increases post-immunization of \\>0.1% of positive CD8+ cells for IFN-gamma or TNF-α over baseline (pre-immunization) values.) or Tumor Necrosis Factor-alpha (TNF-α)) by mass cytometry or flow cytometry.","approximately 5 years",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":17,"primaryPurpose":18,"observationalModel":13,"timePerspective":13,"maskingInfo":19},"NON_RANDOMIZED","PARALLEL","Volunteers who choose to take part in this study will receive the licensed FDA approved Oral Typhoid Vaccine (Vivotif) and\u002For the licensed FDA approved Oral Cholera Vaccine (Vaxchora). Volunteers also have the possibility of being a control participant who will not be vaccinated.","BASIC_SCIENCE",{"masking":20,"maskingDescription":13,"whoMasked":13},"NONE",[22,29,33],{"label":23,"type":24,"description":25,"interventionNames":26},"Vaccination, Endoscopy","EXPERIMENTAL","Individuals receive immunization with Vivotif typhoid vaccine and\u002For Vaxchora cholera vaccine prior to routine endoscopic examination. During endoscopy, small bowel biopsies will be obtained to examine immune responses and microbiota at the mucosal level; brushings might also be obtained.",[27,28],"Drug: Vivotif Typhoid Oral Vaccine","Drug: Vaxchora",{"label":30,"type":24,"description":31,"interventionNames":32},"Endoscopy, Vaccination, Endoscopy","Individuals receive immunization with Vivotif typhoid vaccine and\u002For Vaxchora cholera vaccine after initial endoscopic exam and specimen collection and prior to a routine follow up endoscopic examination during which additional specimens will be collected.",[27,28],{"label":34,"type":35,"description":36,"interventionNames":13},"Endoscopy Without Vaccination","NO_INTERVENTION","Individuals do not receive immunization but consent to collection of specimens during endoscopy. The specimens to be collected in all three groups include stool, saliva, and small bowel biopsies (terminal ileum if colonoscopy performed, duodenum if EGD performed).",[38,45],{"type":39,"name":40,"description":41,"armGroupLabels":42,"otherNames":43},"DRUG","Vivotif Typhoid Oral Vaccine","The 4 doses (1 capsule each) will be administered on alternate days, e.g., days 0, 2, 4, and 7 (± 1 day) under the supervision of the study coordinator(s).",[30,23],[44],"Ty21a Typhoid Oral Vaccine",{"type":39,"name":46,"description":47,"armGroupLabels":48,"otherNames":49},"Vaxchora","One dose. Approximately 100 mL of cool or room temperature purified bottled water is placed into a clean disposable cup. The contents of the buffer sachet are added to the water and stirred. Then the contents of the active (lyophilized vaccine) sachet are added to the water and stirred for approximately 30 seconds. The reconstituted mixture should be completely ingested within 15 minutes.",[30,23],[50],"CVD 103-HgR",[52],{"name":53,"role":54,"phone":55,"phoneExt":13,"email":56},"Rosary Zara Necesario, RN","CONTACT","410-706-6156","rnecesario@som.umaryland.edu",[58],{"facility":59,"status":60,"city":61,"state":62,"zip":63,"country":64,"countryCode":65,"cosmosGeoPoint":66,"geoPoint":71,"contacts":72},"University of Maryland, Baltimore, Center for Vaccine Development and Global Health","RECRUITING","Baltimore","Maryland","21201","United States","US",{"type":67,"coordinates":68},"Point",[69,70],-76.61219,39.29038,{"lat":70,"lon":69},[73],{"name":74,"role":54,"phone":13,"phoneExt":13,"email":75},"Susan Holian, RN","susan.holian@som.umaryland.edu",{"type":77,"investigatorFullName":78,"investigatorTitle":79,"investigatorAffiliation":5,"oldNameTitle":13,"oldOrganization":13},"PRINCIPAL_INVESTIGATOR","Bruce Greenwald","Professor of Medicine","100339905","phase-4-cvd-38000-study-of-responses-to-vaccination-with-typhoid-andor-cholera-100339905",false,"NCT03705585","CVD 38000: Study of Responses to Vaccination With Typhoid and\u002For Cholera","CVD 38000: Immunity, Microbiome, Epigenetics, and a Systems Biology Approach to the Study of Responses to Vaccination With Typhoid and\u002For Cholera","Inclusion Criteria:\n\n* 1\\. Age 18 years and older\n* 2\\. Already scheduled to undergo an EGD or colonoscopy for screening, surveillance, or a medically-indicated work-up at the University of Maryland Medical Center (main campus or Midtown)\n* 3\\. Able to provide written informed consent prior to initiation of any study procedures\n* 4\\. Healthy, as defined by considered fit to undergo outpatient elective EGD\u002Fcolonoscopy by the evaluating health care provider\n\nExclusion Criteria:\n\n* 1\\. Pregnancy or nursing mother\n* 2\\. Known coagulopathy or bleeding disorder preventing mucosal biopsy\n* 3\\. History of Crohn's disease or ulcerative colitis\n* 4\\. For Subjects undergoing lower endoscopy (colonoscopy) only: Surgical removal of the ileocecal valve or any part of the small or large intestine (non-complicated appendectomy will be considered eligible)\n* 5\\. Allergic reaction to oral typhoid or cholera vaccine in the past\n* 6\\. Immunosuppression from illness or treatment, including\n\n  1. immune-deficiency disorders such as Human Immunodeficiency Virus (HIV) or Acquired Immunodeficiency Syndrome (AIDS)\n  2. leukemia, lymphoma, or cancers (localized non-melanoma skin cancers which are deemed inactive should be considered eligible)\n* 7\\. Receipt of any other vaccine two weeks prior to receipt of Ty21a or CVD 103-HgR\n* 8\\. Positive urine pregnancy test (HCG) prior to colonoscopy or vaccination",true,"ALL","18 Years",{"count":91,"type":92},240,"ESTIMATED","INTERVENTIONAL",[95],"PHASE4","This is an open-label, non-randomized study. The purpose of this study is to better understand how vaccines against typhoid fever and cholera affect the normal immune system and bacteria in the intestine. Patients having standard-of-care endoscopies (colonoscopy and\u002For esophagogastroduodenoscopy (EGD)) will be divided into 3 groups:\n\nGroup 1: Vivotif typhoid vaccination and\u002For Vaxchora cholera vaccination then endoscopy Group 2: Endoscopy, then Vivotif typhoid vaccination and\u002For Vaxchora cholera vaccination, then follow-up endoscopy Group 3: Endoscopy without vaccination.\n\nBoth vaccines used in this study are licensed by the Food and Drug Administration (FDA) for travelers to developing countries. Volunteers will be asked to donate tissue, blood, saliva and stool samples for studying how the body responds to the typhoid and\u002For cholera vaccine.",[98],"Typhoid and\u002For Cholera Vaccination","2026-09-01",{"date":101,"type":102},"2026-09-04","ACTUAL",{"date":104,"type":102},"2018-11-05",{"date":106,"type":92},"2029-05-31",{"name":5,"class":6},1]