Ignite Creation Date:
2025-12-24 @ 9:59 PM
Ignite Modification Date:
2026-01-02 @ 6:08 AM
Study NCT ID:
NCT03982732
Status:
UNKNOWN
Last Update Posted:
2019-06-11
First Post:
2019-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Maternal Antibody in Milk After Vaccination
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014917', 'term': 'Whooping Cough'}], 'ancestors': [{'id': 'D001885', 'term': 'Bordetella Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'We will collect samples of colostrum within the first 48 hours following delivery along with a blood sample and a further breastmilk sample at 2 and 6 weeks following delivery.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-08-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2019-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-06-10', 'studyFirstSubmitDate': '2019-06-10', 'studyFirstSubmitQcDate': '2019-06-10', 'lastUpdatePostDateStruct': {'date': '2019-06-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anti PT IgA at less than 48 hours in colostrum', 'timeFrame': 'Within 48 hours of delivery', 'description': 'Anti-pertussis toxin (PT) Immunoglobulin A (IgA) concentration in colostrum'}], 'secondaryOutcomes': [{'measure': 'Total IgA and IgG in colostrum and breastmilk', 'timeFrame': 'Within 48 hours and at 14 and 42 days after delivery', 'description': 'Total IgA and IgG concentration in colostrum and breastmilk'}, {'measure': 'Anti-PT IgA concentration in breastmilk', 'timeFrame': 'At 14 and 42 days following delivery', 'description': 'Anti-PT IgA concentration in breastmilk'}, {'measure': 'Anti-PT IgG concentration in colostrum and breastmilk', 'timeFrame': 'Within 48 hours and at 14 and 42 days after delivery', 'description': 'Anti-PT IgG concentration in colostrum and breastmilk'}, {'measure': 'Anti PT IgG concentration in maternal serum', 'timeFrame': 'Within 48 hours of delivery', 'description': 'Anti PT IgG concentration in maternal serum'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pertussis', 'Vaccination', 'Pregnancy', 'Breastmilk']}, 'descriptionModule': {'briefSummary': 'Single-centre observational pilot study exploring pertussis specific antibody concentration in the breastmilk of women vaccinated against pertussis in pregnancy at different gestational ages. This study is made up of two stages: first stage to confirm recruitment methods and optimise the laboratory assay and a second stage to complete recruitment for the pilot study.', 'detailedDescription': 'Pertussis disease is a highly infectious respiratory illness caused by Bordetella pertussis, which can cause significant morbidity and mortality. There has been an increase in cases in many high income countries with high vaccination coverage and in an attempt to control this, antenatal vaccination programmes have been introduced in several countries, including the UK. Vaccination in pregnancy is a strategy which seeks to boost the maternal antibody levels, increase the placental transfer of antibody and consequently increase the antibody levels in the infant.\n\nHuman breast milk is a dynamic source of nutrition for the infant and is made up of many immunologically active components including antibody. The principal antibody in breastmilk is IgA and it has been shown that the amount of disease specific antibody in breastmilk can be increased by vaccination in pregnancy for a number of pathogens including pertussis. Secretory IgA (sIgA) plays an important role in immune exclusion in which it blocks adhesion of a pathogen onto a mucosal surface. As the first step of pertussis pathogenesis is the adhesion of bacteria to the ciliated respiratory epithelium in the nasopharynx and trachea there is a clear biological rationale for the hypothesis that receiving breast milk containing more IgA could enhance neonatal immunity and consequently the protective effects of vaccination in pregnancy.\n\nThe best time in pregnancy for administering the pertussis vaccination is debated in the literature, with some advocating vaccination in the second trimester and others supporting later vaccination to coincide the time of serum antibody peak with optimum placental transfer. This issue has been considered exclusively from the perspective of serum immunoglobulin G (IgG), but the impact of timing of vaccination in pregnancy on IgA levels in milk may also be important. Previous studies have shown that there is a peak in the pertussis specific IgA in breast milk at day 10 following vaccination, which then declines, and consequently there may be a significant difference in the amount of IgA available in the breastmilk for an infant born to a mother vaccinated at 20 weeks for example, compared to a mother vaccinated at 32 weeks. This may therefore have an impact on future guidelines on optimal time of vaccination in pregnancy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women who received a pertussis vaccination between 16 and 32 weeks and are pregnant or within 48 hours of delivery.', 'genderDescription': 'Participant must have been vaccinated in pregnancy.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Singleton pregnancy\n* Received pertussis vaccination between 16 and 32 gestational weeks\n* Planning to breastfeed\n\nExclusion Criteria:\n\n* Received vaccination outside of the 16-32 week window\n* Not planning to breastfeed\n* Diagnosis of an immunodeficiency syndrome\n* Multiple pregnancy'}, 'identificationModule': {'nctId': 'NCT03982732', 'acronym': 'MAMA', 'briefTitle': 'Maternal Antibody in Milk After Vaccination', 'organization': {'class': 'OTHER', 'fullName': "St George's, University of London"}, 'officialTitle': 'Maternal Antibody in Milk After Vaccination', 'orgStudyIdInfo': {'id': '18.0068'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Women vaccinated at less than 24 weeks', 'description': 'Women receiving a pertussis containing vaccine at less than 24 weeks', 'interventionNames': ['Biological: Boostrix-IPV']}, {'label': 'Women vaccinated at 24-27+6 weeks', 'description': 'Women receiving a pertussis containing vaccine at 24-27+6 weeks', 'interventionNames': ['Biological: Boostrix-IPV']}, {'label': 'Women vaccinated at 28-31+6 weeks', 'description': 'Women receiving a pertussis containing vaccine at 28-31+6 weeks', 'interventionNames': ['Biological: Boostrix-IPV']}], 'interventions': [{'name': 'Boostrix-IPV', 'type': 'BIOLOGICAL', 'description': 'Receipt of Boostrix IPV at three different gestational time periods', 'armGroupLabels': ['Women vaccinated at 24-27+6 weeks', 'Women vaccinated at 28-31+6 weeks', 'Women vaccinated at less than 24 weeks']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SW17 0QT', 'city': 'Tooting', 'state': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Anna Calvert', 'role': 'CONTACT', 'email': 'acalvert@sgul.ac.uk'}], 'facility': 'St Georges University Hospital NHS Foundation Trust', 'geoPoint': {'lat': 51.42524, 'lon': -0.16394}}], 'centralContacts': [{'name': 'Anna Calvert, MBChB', 'role': 'CONTACT', 'email': 'acalvert@sgul.ac.uk', 'phone': '02087253887'}, {'name': 'Kirsty Le Doare', 'role': 'CONTACT', 'email': 'kiledoar@sgul.ac.uk', 'phone': '02087253887'}], 'overallOfficials': [{'name': 'Kirsty Le Doare', 'role': 'STUDY_DIRECTOR', 'affiliation': "St George's, Univeristy of London"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "St George's, University of London", 'class': 'OTHER'}, 'collaborators': [{'name': 'European Society for Paediatric Infectious Diseases', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}