Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-27 @ 5:45 AM
Study NCT ID:
NCT05543993
Status:
COMPLETED
Last Update Posted:
2025-12-02
First Post:
2022-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
COVID Booster in Pregnancy and Lactation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D001942', 'term': 'Breast Feeding'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Maternal blood Cord blood Breastmilk Infant blood Infant oral'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2024-06-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-24', 'studyFirstSubmitDate': '2022-09-14', 'studyFirstSubmitQcDate': '2022-09-14', 'lastUpdatePostDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-09-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maternal Serological Profile', 'timeFrame': '3 months', 'description': 'Quantitative Maternal IgG to SARS CoV2 spike and other domains'}, {'measure': 'Maternal Functional Immunity', 'timeFrame': '3 months', 'description': 'Quantitative Antibody neutralization capacity'}], 'secondaryOutcomes': [{'measure': 'Infant serological profile', 'timeFrame': '3 months old', 'description': 'Quantitative IgG to SARS CoV2'}, {'measure': 'Infant functional immunity', 'timeFrame': '3 months old', 'description': 'Quantitative Antibody neutralization capacity'}, {'measure': 'Breastmilk serological profile', 'timeFrame': '3 months', 'description': 'Quantitative IgA to SARS CoV2'}, {'measure': 'Infant oral immunity', 'timeFrame': '3 months', 'description': 'Quantitative Salivary SARS CoV2 IgG'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['vaccine', 'COVID-19 vaccine', 'booster', 'pregnancy', 'breastfeeding', 'immunity'], 'conditions': ['COVID-19']}, 'descriptionModule': {'briefSummary': 'This is a prospective longitudinal cohort study to evaluate the impact of COVID-19 vaccination and booster on maternal and infant immunity against COVID-19 variants over time.', 'detailedDescription': 'We will enroll 100 pregnant patients who have received COVID-19 mRNA booster as well as 100 breastfeeding patients who have received COVID-19 mRNA booster. Participants will be following longitudinally through 3 months post partum, or 3 months post enrollment for those in the breastfeeding cohort. Maternal blood will be collected, as will cordblood at delivery, breastmilk, and infant samples.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '55 Years', 'minimumAge': '13 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '1. Pregnant singleton gestation who have received bivalent COVID-19 mRNA booster in pregnancy\n2. Breastfeeding individuals who have recieved bivalent COVID-19 mRNA booster', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Singleton gestation\n* Received mRNA bivalent COVID-19 booster during 1) pregnancy or 2) breastfeeding\n\nExclusion Criteria:\n\n* Multifetal gestation\n* Unable to provide consent'}, 'identificationModule': {'nctId': 'NCT05543993', 'briefTitle': 'COVID Booster in Pregnancy and Lactation', 'organization': {'class': 'OTHER', 'fullName': 'Thomas Jefferson University'}, 'officialTitle': 'Serological and Functional Impact of COVID-19 Vaccination on the Maternal Fetal Unit and Infant Immunity', 'orgStudyIdInfo': {'id': '22F.452'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'COVID-19 booster in pregnancy', 'description': 'Pregnant singletons who have received COVID-19 booster in pregnancy', 'interventionNames': ['Drug: Bivalent COVID-19 Booster']}, {'label': 'COVID-19 booster in breastfeeding', 'description': 'Breastfeeding individuals who have received COVID-19 booster while breastfeeding', 'interventionNames': ['Drug: Bivalent COVID-19 Booster']}], 'interventions': [{'name': 'Bivalent COVID-19 Booster', 'type': 'DRUG', 'description': 'Bivalent COVID-19 Booster by Pfizer or Moderna', 'armGroupLabels': ['COVID-19 booster in breastfeeding', 'COVID-19 booster in pregnancy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson University Hospital', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Rupsa C Boelig, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Thomas Jefferson University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Data will be available 12 months after publication of primary results and for up to 2 years', 'ipdSharing': 'YES', 'description': 'Data collected will be shared in a de-identified manner upon completion of appropriate data sharing agreements', 'accessCriteria': 'Data collected will be shared in a de-identified manner upon completion of appropriate data sharing agreements'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Thomas Jefferson University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Walter Reed Army Institute of Research (WRAIR)', 'class': 'FED'}, {'name': 'Nemours Childrens Health', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Rupsa C. Boelig', 'investigatorAffiliation': 'Thomas Jefferson University'}}}}