Ignite Creation Date:
2025-12-24 @ 11:07 PM
Ignite Modification Date:
2025-12-25 @ 8:39 PM
Study NCT ID:
NCT06116669
Status:
RECRUITING
Last Update Posted:
2024-01-24
First Post:
2023-10-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Oral Iron Supplementation Before vs at Time of Vaccination on Immune Response in Iron Deficient Kenyan Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018798', 'term': 'Anemia, Iron-Deficiency'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000086663', 'term': 'COVID-19 Vaccines'}, {'id': 'C057664', 'term': 'Vi polysaccharide vaccine, typhoid'}], 'ancestors': [{'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-22', 'studyFirstSubmitDate': '2023-10-30', 'studyFirstSubmitQcDate': '2023-10-30', 'lastUpdatePostDateStruct': {'date': '2024-01-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'JJ COVID-19 vaccine response', 'timeFrame': 'Day 56', 'description': 'Anti-spike (S1) IgG and anti-receptor-binding domain (RBD) IgG against SARS-COV-2'}, {'measure': 'MenACWY vaccine response', 'timeFrame': 'Day 56', 'description': 'Measurement of antibody response against serogroups A, C, W, and Y.'}, {'measure': 'Typhoid vaccine response', 'timeFrame': 'Day 56', 'description': 'Measurement of antibody response against Typhoid'}], 'secondaryOutcomes': [{'measure': 'Hemoglobin', 'timeFrame': 'Day 1', 'description': 'iron status'}, {'measure': 'Hemoglobin', 'timeFrame': 'Day 28', 'description': 'iron status'}, {'measure': 'Hemoglobin', 'timeFrame': 'Day 56', 'description': 'iron status'}, {'measure': 'Serum ferritin', 'timeFrame': 'Day 1', 'description': 'iron status'}, {'measure': 'Serum ferritin', 'timeFrame': 'Day 28', 'description': 'iron status'}, {'measure': 'Serum ferritin', 'timeFrame': 'Day 56', 'description': 'iron status'}, {'measure': 'soluble transferrin receptor', 'timeFrame': 'Day 1', 'description': 'iron status'}, {'measure': 'soluble transferrin receptor', 'timeFrame': 'Day 28', 'description': 'iron status'}, {'measure': 'soluble transferrin receptor', 'timeFrame': 'Day 56', 'description': 'iron status'}, {'measure': 'Plasma iron', 'timeFrame': 'Day 1', 'description': 'iron status'}, {'measure': 'Plasma iron', 'timeFrame': 'Day 28', 'description': 'iron status'}, {'measure': 'Plasma iron', 'timeFrame': 'Day 56', 'description': 'iron status'}, {'measure': 'Total iron binding capacity', 'timeFrame': 'Day 1', 'description': 'iron status'}, {'measure': 'Total iron binding capacity', 'timeFrame': 'Day 28', 'description': 'iron status'}, {'measure': 'Total iron binding capacity', 'timeFrame': 'Day 56', 'description': 'iron status'}, {'measure': 'Transferrin saturation', 'timeFrame': 'Day 1', 'description': 'iron status'}, {'measure': 'Transferrin saturation', 'timeFrame': 'Day 28', 'description': 'iron status'}, {'measure': 'Transferrin saturation', 'timeFrame': 'Day 56', 'description': 'iron status'}, {'measure': 'C- reactive protein', 'timeFrame': 'Day 1', 'description': 'inflammation status'}, {'measure': 'C- reactive protein', 'timeFrame': 'Day 28', 'description': 'inflammation status'}, {'measure': 'C- reactive protein', 'timeFrame': 'Day 56', 'description': 'inflammation status'}, {'measure': 'alpha- 1- glycoprotein', 'timeFrame': 'Day 1', 'description': 'inflammation status'}, {'measure': 'alpha- 1- glycoprotein', 'timeFrame': 'Day 28', 'description': 'inflammation status'}, {'measure': 'alpha- 1- glycoprotein', 'timeFrame': 'Day 56', 'description': 'inflammation status'}, {'measure': 'Retinol binding protein', 'timeFrame': 'Day 1', 'description': 'Vitamin A status'}, {'measure': 'Retinol binding protein', 'timeFrame': 'Day 28', 'description': 'Vitamin A status'}, {'measure': 'Retinol binding protein', 'timeFrame': 'Day 56', 'description': 'Vitamin A status'}, {'measure': 'Plasma zinc', 'timeFrame': 'Day 1', 'description': 'Zinc status'}, {'measure': 'COVID-19 specific T cell response', 'timeFrame': 'Day 28', 'description': 'QuantiFERON SARS-CoV-2 whole blood assay - detection of IFN-gamma'}, {'measure': 'COVID-19 specific T cell response', 'timeFrame': 'Day 56', 'description': 'QuantiFERON SARS-CoV-2 whole blood assay - detection of IFN-gamma'}, {'measure': 'COVID-19 specific T cell response', 'timeFrame': 'Day 28', 'description': 'ELISpot assay on isolated peripheral blood mononuclear cells'}, {'measure': 'COVID-19 specific T cell response', 'timeFrame': 'Day 56', 'description': 'ELISpot assay on isolated peripheral blood mononuclear cells'}, {'measure': 'Typhim Vi specific B-cell response', 'timeFrame': 'Day 28', 'description': 'ELISpot assay on isolated peripheral blood mononuclear cells'}, {'measure': 'Typhim Vi specific B-cell response', 'timeFrame': 'Day 56', 'description': 'ELISpot assay on isolated peripheral blood mononuclear cells'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Iron Deficiency Anemia']}, 'descriptionModule': {'briefSummary': 'Iron deficiency (ID) anemia (IDA) is a global public health problem, with the highest prevalence in Africa. Vaccines often underperform in low- and middle-income countries (LMIC), and undernutrition, including ID, likely plays a role. Recent studies have shown the importance of iron status in vaccine response. Intravenous iron given at time of vaccination improved response to yellow fever and COVID-19 vaccines in IDA Kenyan women. Whether oral iron treatment would have a similar beneficial effect on vaccine response is uncertain. Also, timing of oral iron treatment needs further investigation.\n\nThe co-primary objectives of this study are to assess 1) whether IDA in Kenyan women impairs vaccine response, and whether oral iron treatment improves their response; 2) the timing of oral iron treatment to improve vaccine response (prior to vaccination vs at time of vaccination).\n\nWe will conduct a double-blind randomized controlled trial in southern Kenya to assess the effects of iron supplementation on response to three single-shot vaccines: Johnson \\& Johnson COVID- 19 (JJ COVID-19), the quadrivalent meningococcal vaccine (MenACWY) and the typhoid Vi polysaccharide vaccine (Typhim Vi). Women with IDA will be recruited and randomly assigned to three study groups: group 1 (pre- treatment) will receive 100 mg oral iron as ferrous sulfate (FeSO4) daily on days 1-56; group 2 (simultaneous treatment) will receive matching placebo daily on days 1-28, and 200 mg oral iron as FeSO4 daily on days 29-56; and group 3 (control) will receive matching placebo daily on days 1-56. Women in all groups will receive the JJ COVID-19 vaccine, the MenACWY and the Typhim Vi vaccine on day 28. Cellular immune response and serology will be measured at 28 days after vaccination in all groups.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Willing and able to give informed consent for participation in the trial\n* Female aged 18-49 years\n* Moderate anemia (Hb \\<110 g/L, but not severely anemic with Hb \\<80 g/L)\n* Iron deficient (ZnPP \\>40 mmol/mol haem)\n* Anticipated residence in the study area for the study duration\n\nExclusion Criteria:\n\n* Major chronic infecious disease (e.g., HIV infection);\n* Major chronic non-infecious disease (e.g., Type 2 diabetes, cancer);\n* Chronic medications;\n* Use of iron-containing mineral and vitamin supplementation 2 weeks prior to study start;\n* COVID-19 vaccine or confirmed COVID-19 infection within the past 2 years\n* MenACWY vaccine in the past\n* Typhim Vi vaccine in the past\n* Pregnant (confirmed by rapid test during screening)\n* Malaria (confirmed by rapid test) à study start will be postponed'}, 'identificationModule': {'nctId': 'NCT06116669', 'acronym': 'DIVA_II', 'briefTitle': 'Effects of Oral Iron Supplementation Before vs at Time of Vaccination on Immune Response in Iron Deficient Kenyan Women', 'organization': {'class': 'OTHER', 'fullName': 'Swiss Federal Institute of Technology'}, 'officialTitle': 'Effects of Oral Iron Supplementation Before vs at Time of Vaccination on Immune Response in Iron Deficient Kenyan Women', 'orgStudyIdInfo': {'id': 'DIVA_II'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pre-treatment group', 'description': 'Participants assigned to this group will receive 100 mg oral iron daily on study days 1-56.', 'interventionNames': ['Dietary Supplement: Iron supplementation', 'Biological: MenACWY vaccine', 'Biological: COVID-19 vaccine', 'Biological: Typhim Vi vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'Simultaneous treatment group', 'description': 'Participants assigned to this group will receive placebo daily on study days 1-28 and 100 mg oral iron daily on study days 29-56.', 'interventionNames': ['Dietary Supplement: Iron supplementation', 'Biological: MenACWY vaccine', 'Biological: COVID-19 vaccine', 'Other: Placebo', 'Biological: Typhim Vi vaccine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'Participants assigned to this group will receive placebo daily on study days 1-56.', 'interventionNames': ['Dietary Supplement: Iron supplementation', 'Biological: MenACWY vaccine', 'Biological: COVID-19 vaccine', 'Other: Placebo', 'Biological: Typhim Vi vaccine']}], 'interventions': [{'name': 'Iron supplementation', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Iron supplements as 100 mg oral iron as FeSO4 given daily', 'armGroupLabels': ['Control group', 'Pre-treatment group', 'Simultaneous treatment group']}, {'name': 'MenACWY vaccine', 'type': 'BIOLOGICAL', 'description': 'MenACWY vaccination given on day 28 to all participants', 'armGroupLabels': ['Control group', 'Pre-treatment group', 'Simultaneous treatment group']}, {'name': 'COVID-19 vaccine', 'type': 'BIOLOGICAL', 'description': 'Johnson \\& Johnson COVID- 19 (JJ COVID-19) vaccination given on day 28 to all participants', 'armGroupLabels': ['Control group', 'Pre-treatment group', 'Simultaneous treatment group']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'matching placebo capsules given daily', 'armGroupLabels': ['Control group', 'Simultaneous treatment group']}, {'name': 'Typhim Vi vaccine', 'type': 'BIOLOGICAL', 'description': 'Typhim Vi vaccination given on day 28 to all participants', 'armGroupLabels': ['Control group', 'Pre-treatment group', 'Simultaneous treatment group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00200', 'city': 'Nairobi', 'status': 'RECRUITING', 'country': 'Kenya', 'contacts': [{'name': 'Simon Karanja, PhD', 'role': 'CONTACT', 'email': 'skaranja@jkuat.ac.ke', 'phone': '+254726424669'}], 'facility': 'Jomo Kenyatta University Of Agriculture And Technology', 'geoPoint': {'lat': -1.28333, 'lon': 36.81667}}], 'centralContacts': [{'name': 'Giulia Pironaci, MSc', 'role': 'CONTACT', 'email': 'giulia.pironaci@hest.ethz.ch', 'phone': '+41 44 632 93 29'}, {'name': 'Nicole Stoffel, PhD', 'role': 'CONTACT', 'email': 'nicole.stoffel@hest.ethz.ch', 'phone': '+41 44 632 83 93'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Swiss Federal Institute of Technology', 'class': 'OTHER'}, 'collaborators': [{'name': 'Jomo Kenyatta University of Agriculture and Technology', 'class': 'OTHER'}, {'name': 'University of Oxford', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}