Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2025-12-27 @ 12:31 PM
Study NCT ID:
NCT06716567
Status:
COMPLETED
Last Update Posted:
2025-03-24
First Post:
2024-11-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Maternal Determinants of Immunity to Influenza
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D007251', 'term': 'Influenza, Human'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract 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'}], 'ancestors': [{'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Researchers analyzing the immunological outcomes are blinded to the groups of the subjects (pregnant vs non-pregnant).'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Pregnant women and non-pregnant women are recruited in parallel.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 109}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2023-11-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-19', 'studyFirstSubmitDate': '2024-11-29', 'studyFirstSubmitQcDate': '2024-11-29', 'lastUpdatePostDateStruct': {'date': '2025-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Haemagglutination Inhibition Assay titre', 'timeFrame': '28 days post vaccination', 'description': 'Haemagglutination Inhibition Assay (HAI) titres are used to measure responses to relevant influenza strains. The HAI method exploits the property of the influenza virus to haemagglutinate red blood cells. HAI titres are determined as the highest serum dilution inhibiting haemagglutination. An HAI titre of \\>=40 is considered protective in adults.\n\nHAI titres will be measured in :\n\n* Pregnant women\n* Non-pregnant women'}, {'measure': 'Haemagglutination Inhibition Assay titre', 'timeFrame': 'At delivery', 'description': 'Haemagglutination Inhibition Assay (HAI) titres are used to measure responses to relevant influenza strains. The HAI method exploits the property of the influenza virus to haemagglutinate red blood cells. HAI titres are determined as the highest serum dilution inhibiting haemagglutination. An HAI titre of \\>=40 is considered protective in adults.\n\nHAI titres will be measured in :\n\n* Pregnant women\n* In umbilical cord blood'}], 'secondaryOutcomes': [{'measure': 'Haemagglutination inhibition assay titre', 'timeFrame': 'up to 11 months after vaccination', 'description': 'Haemagglutination Inhibition Assay (HAI) titres are used to measure responses to relevant influenza strains. The HAI method exploits the property of the influenza virus to haemagglutinate red blood cells. HAI titres are determined as the highest serum dilution inhibiting haemagglutination. An HAI titre of \\>=40 is considered protective in adults.\n\nHAI titres will be measured in :\n\n* Pregnant women: at day of vaccination, day 7 post-vaccination, day 28 post-vaccination, at delivery, week 6 and 12 post-delivery\n* Non-pregnant women: at day of vaccination, day 7, day 28, and Month 6 post-vaccination'}, {'measure': 'Micro neutralization assay titre', 'timeFrame': 'up to 11 months after vaccination', 'description': 'Micro neutralization assay (MNA) titres are measured on serum samples with detectable HAI titres to determine cross reactivity to related virus strains. This method assesses the ability of serum antibodies to prevent virus from infecting a single layer of cells in a micro titre plate.\n\nMNA titres will be measured in :\n\n* Pregnant women: at day of vaccination, day 7 post-vaccination, day 28 post-vaccination, at delivery, week 6 and 12 post-delivery\n* Non-pregnant women: at day of vaccination, day 7, day 28, and Month 6 post-vaccination'}, {'measure': 'Influenza virus specific IgG titre', 'timeFrame': 'up to 11 month after vaccination', 'description': 'IgG titres specific to influenza virus Hemagglutinin (HA) and Neuraminidase (NA) are measured using conventional Enzyme-linked immunosorbent assay (ELISA) methods. The Enzyme-Linked Lectin Assay (ELLA) is used for detection of NA-specific antibodies only, using reverse genetics viruses with irrelevant HA to ensure only NA antibodies are measured. ELLA is an ELISA variant but adapted to measure the concentration of antibody to NA, determining the amount of sialic acid cleaved from fetuin.\n\nIgG titres specific to Influenza Antigens will be assessed by ELISA and ELLA in:\n\n* Pregnant women: at day of vaccination, day 7 post-vaccination, day 28 post-vaccination, at delivery, week 6 and 12 post-delivery\n* Non-pregnant women: at day of vaccination, day 7, day 28, and Month 6 post-vaccination'}, {'measure': 'Influenza virus specific IgG antibody avidity', 'timeFrame': 'up to 11 months after vaccination', 'description': 'IgG avidity will be measured using chaotropic salts.\n\nIgG avidity will be assessed in :\n\n* Pregnant women: at day of vaccination, day 7 post-vaccination, day 28 post-vaccination, at delivery, week 6 and 12 post-delivery\n* Non-pregnant women: at day of vaccination, day 7, day 28, and Month 6 post-vaccination'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Vaccination; Infection', 'Maternal-Fetal Relations', 'Influenza', 'Immunoglobulins']}, 'descriptionModule': {'briefSummary': 'The overall objective of the project is to determine the impact of pregnancy on the response to influenza immunization.', 'detailedDescription': 'The study compares immune responses to influenza vaccination between a group of pregnant women and a group of non-pregnant controls women. Specifically, the study has three aims:\n\n1. To compare the quality of antibodies induced by influenza immunization in pregnant and non-pregnant women;\n2. To identify immune predictors of vaccine responses in pregnant women and compare them to the determinants of vaccine responses in non-pregnant women;\n3. To identify immune predictors of the transfer of maternal antibodies to the newborn following influenza immunization during pregnancy;'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age over 18 and under 40 years.\n\nExclusion Criteria:\n\n* Grade III/IV anemia\n* Human Immunodeficiency Virus (HIV) infection\n* Active bacterial infection\n* Opportunistic infection (Tuberculosis, cytomegalovirus (CMV), toxoplasmosis, etc)\n* Inability to understand the nature and extent of the study and the procedures required\n* Current or recent use of immunosuppressive drugs (corticosteroids, anti-tumor necrosis factors (anti-TNF), methotrexate, etc)\n* Active neoplasia'}, 'identificationModule': {'nctId': 'NCT06716567', 'acronym': 'MADI-01', 'briefTitle': 'Maternal Determinants of Immunity to Influenza', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Saint Pierre'}, 'officialTitle': 'Maternal Determinants of Immunity to Influenza (MADI-01)', 'orgStudyIdInfo': {'id': 'B762020201013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Pregnant women', 'description': 'Pregnant women receive one dose of influenza-containing vaccine during pregnancy.', 'interventionNames': ['Biological: Influenza vaccine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Non-pregnant women', 'description': 'Non-pregnant women receive one dose of influenza-containing vaccine.', 'interventionNames': ['Biological: Influenza vaccine']}], 'interventions': [{'name': 'Influenza vaccine', 'type': 'BIOLOGICAL', 'description': 'Alpharix-Tetra®, Vaxigrip Tetra® and Influvac Tetra® were used as influenza vaccines in the 2020-2021, 2021-2022, and 2022-2023 seasons respectively.', 'armGroupLabels': ['Non-pregnant women', 'Pregnant women']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1000', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'CHU Saint-Pierre', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire Saint Pierre', 'class': 'OTHER'}, 'collaborators': [{'name': 'Université Libre de Bruxelles', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor, Infectious Disease Department', 'investigatorFullName': 'Nicolas Dauby', 'investigatorAffiliation': 'Centre Hospitalier Universitaire Saint Pierre'}}}}