Ignite Creation Date:
2025-12-24 @ 12:03 PM
Ignite Modification Date:
2026-04-24 @ 4:56 PM
Study NCT ID:
NCT04912661
Status:
COMPLETED
Last Update Posted:
2021-09-14
First Post:
2021-05-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Iron and Vaccine Response
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018798', 'term': 'Anemia, Iron-Deficiency'}, {'id': 'D000079263', 'term': 'Vaccine-Preventable Diseases'}], 'ancestors': [{'id': 'D000747', 'term': 'Anemia, Hypochromic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D000090463', 'term': 'Iron Deficiencies'}, {'id': 'D019189', 'term': 'Iron Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C522335', 'term': 'ferric carboxymaltose'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 121}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-09-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-10', 'studyFirstSubmitDate': '2021-05-28', 'studyFirstSubmitQcDate': '2021-05-28', 'lastUpdatePostDateStruct': {'date': '2021-09-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Antibody titers', 'timeFrame': 'at 35 days'}, {'measure': 'Antibody titers', 'timeFrame': 'at 63 days'}, {'measure': 'Seroconversion', 'timeFrame': 'at 35 days'}, {'measure': 'Seroconversion', 'timeFrame': 'at 63 days'}, {'measure': 'Antibody avidity Index', 'timeFrame': 'at 35 days', 'description': 'percentage of antibodies that remain bound to beads'}, {'measure': 'Antibody avidity Index', 'timeFrame': 'at 63 days', 'description': 'percentage of antibodies that remain bound to beads'}], 'secondaryOutcomes': [{'measure': 'antiviral immunoglobulin G response', 'timeFrame': 'day 0', 'description': 'Immunoassay'}, {'measure': 'antiviral immunoglobulin G response', 'timeFrame': 'day 7', 'description': 'Immunoassay'}, {'measure': 'antiviral immunoglobulin G response', 'timeFrame': 'day 35', 'description': 'Immunoassay'}, {'measure': 'antiviral immunoglobulin G response', 'timeFrame': 'day 63', 'description': 'Immunoassay'}, {'measure': 'immune cell populations', 'timeFrame': 'day 0', 'description': 'number and type of immune cells'}, {'measure': 'immune cell populations', 'timeFrame': 'day 7', 'description': 'number and type of immune cells'}, {'measure': 'immune cell populations', 'timeFrame': 'day 35', 'description': 'number and type of immune cells'}, {'measure': 'immune cell populations', 'timeFrame': 'day 63', 'description': 'number and type of immune cells'}, {'measure': 'Proteomics', 'timeFrame': 'day 0', 'description': 'Proteins involved in immune response'}, {'measure': 'Proteomics', 'timeFrame': 'day 7', 'description': 'Proteins involved in immune response'}, {'measure': 'Proteomics', 'timeFrame': 'day 35', 'description': 'Proteins involved in immune response'}, {'measure': 'Proteomics', 'timeFrame': 'day 63', 'description': 'Proteins involved in immune response'}, {'measure': 'Transcriptomics', 'timeFrame': 'day 0', 'description': 'Genes involved in immune response'}, {'measure': 'Transcriptomics', 'timeFrame': 'day 7', 'description': 'Genes involved in immune response'}, {'measure': 'Transcriptomics', 'timeFrame': 'day 35', 'description': 'Genes involved in immune response'}, {'measure': 'Transcriptomics', 'timeFrame': 'day 63', 'description': 'Genes involved in immune response'}, {'measure': 'Immune cell cytokine secretion', 'timeFrame': 'day 7', 'description': 'ELISpot'}, {'measure': 'Immune cell cytokine secretion', 'timeFrame': 'day 35', 'description': 'ELISpot'}, {'measure': 'Hemoglobin', 'timeFrame': 'day 0', 'description': 'iron status parameter'}, {'measure': 'Hemoglobin', 'timeFrame': 'day 7', 'description': 'iron status parameter'}, {'measure': 'Hemoglobin', 'timeFrame': 'day 35', 'description': 'iron status parameter'}, {'measure': 'Hemoglobin', 'timeFrame': 'day 63', 'description': 'iron status parameter'}, {'measure': 'Plasma Ferritin', 'timeFrame': 'day 0', 'description': 'iron status parameter'}, {'measure': 'Plasma Ferritin', 'timeFrame': 'day 7', 'description': 'iron status parameter'}, {'measure': 'Plasma Ferritin', 'timeFrame': 'day 35', 'description': 'iron status parameter'}, {'measure': 'Plasma Ferritin', 'timeFrame': 'day 63', 'description': 'iron status parameter'}, {'measure': 'Transferrin receptor', 'timeFrame': 'day 0', 'description': 'iron status parameter'}, {'measure': 'Transferrin receptor', 'timeFrame': 'day 7', 'description': 'iron status parameter'}, {'measure': 'Transferrin receptor', 'timeFrame': 'day 35', 'description': 'iron status parameter'}, {'measure': 'Transferrin receptor', 'timeFrame': 'day 63', 'description': 'iron status parameter'}, {'measure': 'Transferrin saturation', 'timeFrame': 'day 0', 'description': 'iron status parameter'}, {'measure': 'Transferrin saturation', 'timeFrame': 'day 7', 'description': 'iron status parameter'}, {'measure': 'Transferrin saturation', 'timeFrame': 'day 35', 'description': 'iron status parameter'}, {'measure': 'Transferrin saturation', 'timeFrame': 'day 63', 'description': 'iron status parameter'}, {'measure': 'C-reactive protein', 'timeFrame': 'day 0', 'description': 'inflammation status parameter'}, {'measure': 'C-reactive protein', 'timeFrame': 'day 7', 'description': 'inflammation status parameter'}, {'measure': 'C-reactive protein', 'timeFrame': 'day 35', 'description': 'inflammation status parameter'}, {'measure': 'C-reactive protein', 'timeFrame': 'day 63', 'description': 'inflammation status parameter'}, {'measure': 'Alpha-glycoprotein', 'timeFrame': 'day 0', 'description': 'inflammation status parameter'}, {'measure': 'Alpha-glycoprotein', 'timeFrame': 'day 7', 'description': 'inflammation status parameter'}, {'measure': 'Alpha-glycoprotein', 'timeFrame': 'day 28', 'description': 'inflammation status parameter'}, {'measure': 'Alpha-glycoprotein', 'timeFrame': 'day 56', 'description': 'inflammation status parameter'}, {'measure': 'retinol binding protein', 'timeFrame': 'day 0', 'description': 'marker for Vitamin A status'}, {'measure': 'retinol binding protein', 'timeFrame': 'day 7', 'description': 'marker for Vitamin A status'}, {'measure': 'retinol binding protein', 'timeFrame': 'day 35', 'description': 'marker for Vitamin A status'}, {'measure': 'retinol binding protein', 'timeFrame': 'day 63', 'description': 'marker for Vitamin A status'}, {'measure': 'plasma zinc', 'timeFrame': 'day 0'}, {'measure': 'plasma zinc', 'timeFrame': 'day 7'}, {'measure': 'plasma zinc', 'timeFrame': 'day 35'}, {'measure': 'plasma zinc', 'timeFrame': 'day 63'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Iron Deficiency Anemia', 'Vaccine Preventable Disease', 'Vaccine Response Impaired', 'Iron Deficiency Anemia Treatment']}, 'descriptionModule': {'briefSummary': 'Vaccines often underperform in Africa compared to high-income countries. Why vaccines do not work as well in Africa remains uncertain. Malnutrition likely plays a role. Our study objective is to assess whether iron deficiency anaemia in young women impairs their immune response to viral vaccines, and whether iron treatment improves their response.', 'detailedDescription': 'Group 1 (immediate iron treatment) will receive iron treatment before vaccination. Women in both groups will receive two intramuscular vaccines (influenza and yellow fever). Vaccine response will be measured 28 and 56 days after vaccine administration in both groups. Group 2 (delayed iron treatment) will receive iron treatment at study end.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-55 years old\n* Zinc protoporphyrin \\> or equal 40 mmol/mol heme\n* hemoglobin \\< or equal 109 g/L\n* no malaria\n* no known HIV infection\n* no medical condition that precludes study involvement\n* no iron supplementation 1 week prior to study start\n* no recent tuberculosis infection\n* no vaccination of yellow fever or influenza prior to enrolment\n* not pregnant\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT04912661', 'briefTitle': 'Iron and Vaccine Response', 'organization': {'class': 'OTHER', 'fullName': 'Swiss Federal Institute of Technology'}, 'officialTitle': 'Iron and Vaccine-preventable Viral Disease - an Experimental Study', 'orgStudyIdInfo': {'id': 'DIVA I'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Immediate iron treatment', 'description': 'intravenous iron carboxymaltose before vaccination', 'interventionNames': ['Dietary Supplement: Ferinject']}, {'type': 'NO_INTERVENTION', 'label': 'No iron treatment', 'description': 'no intravenous iron carboxymaltose before vaccination'}], 'interventions': [{'name': 'Ferinject', 'type': 'DIETARY_SUPPLEMENT', 'description': 'intravenous iron carboxymaltose', 'armGroupLabels': ['Immediate iron treatment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Msambweni', 'state': 'Kwale County', 'country': 'Kenya', 'facility': 'Msambweni County Referral Hospital', 'geoPoint': {'lat': -4.4619, 'lon': 39.48265}}], 'overallOfficials': [{'name': 'Nicole Stoffel, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ETH Zurich'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Swiss Federal Institute of Technology', 'class': 'OTHER'}, 'collaborators': [{'name': 'Jomo Kenyatta University of Agriculture and Technology', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Nicole Stoffel', 'investigatorAffiliation': 'Swiss Federal Institute of Technology'}}}}