Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 2:42 AM
Study NCT ID:
NCT07356050
Status:
RECRUITING
Last Update Posted:
2026-01-21
First Post:
2026-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Verifying Antibodies After Live Immunization Delivery (VALID): A Study of Measles Vaccine Immunogenicity in Children With Sickle Cell Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000755', 'term': 'Anemia, Sickle Cell'}], 'ancestors': [{'id': 'D000745', 'term': 'Anemia, Hemolytic, Congenital'}, {'id': 'D000743', 'term': 'Anemia, Hemolytic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006453', 'term': 'Hemoglobinopathies'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'At maximum, 3 mL of whole blood will be collected from participants. Plasma will be separated from the whole blood sample.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 130}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-20', 'studyFirstSubmitDate': '2026-01-07', 'studyFirstSubmitQcDate': '2026-01-20', 'lastUpdatePostDateStruct': {'date': '2026-01-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measles Seroconversion Rates 8 Weeks After MV1 and MV2 Vaccinations', 'timeFrame': 'From enrollment to the end of sample collection at 8 weeks', 'description': 'Sample analysis of 126 participants 8-weeks post complete measles vaccination.'}], 'secondaryOutcomes': [{'measure': 'Measles Seroconversion Rates 4 Weeks After MV1 Vaccination', 'timeFrame': 'From enrollment to the end of sample collection at 4-weeks post first vaccination.', 'description': "Sample analysis of participants' seroconversion rates 4-weeks post first vaccination."}, {'measure': 'Measles Seroconversion Rates 4 Weeks after MV2 Vaccination', 'timeFrame': 'From second vaccination to end of sample collection at 4-weeks post second vaccination.', 'description': "The sample analysis of participant's seroconversion rates 4-weeks post second vaccination."}, {'measure': 'Variables Associated with Measles Vaccine-induced Antibody Response', 'timeFrame': 'From enrollment to the end of sample collection at 8 weeks.', 'description': "Identify participant's demographic, clinical history, and sickle cell treatments as variables to measles antibody response."}, {'measure': 'Modalities for Sample Analysis', 'timeFrame': 'Through study completion, an average of 12 weeks.', 'description': 'Compare sample analysis results between the gold standard (serum or plasma) and Mitra sample using dried blood spot or whole blood.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Measles Vaccine Immunogenicity'], 'conditions': ['Sickle Cell Disease', 'Measles Vaccination', 'Sickle Cell Anemia']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to learn if infants with sickle cell disease (SCD) develop adequate protection after measles vaccines. (not looking at any prolonged duration)', 'detailedDescription': 'Families of infants with SCD who are eligible for a measles vaccine per standard care will be contacted to discuss enrollment in the study. One cohort will be evaluated for response to the first measles vaccine (MV1) and another cohort will be evaluated for response to the second measles vaccine (MV2). Blood samples will be collected from participants prior to measles vaccination and then again at 4 and 8 weeks after vaccination.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '6 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children from 6 months to 6 years old with Sickle Cell Disease who receive medical care in Cincinnati, Ohio; Accra, Ghana; and Mwanza, Tanzania will be eligible.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Participants with confirmed Sickle Cell Disease.\n2. Participants 6 months and 6 years of age and due for measles vaccination within 3 months per national guidelines.\n3. Willing and able to provide informed consent\n4. Ability to comply with study related evaluations and follow-up visits.\n\nExclusion Criteria:\n\n1\\. Known primary immunodeficiency syndrome, cancer, or acquired immunodeficiency syndrome (AIDS) that would preclude vaccination with live virus vaccines.'}, 'identificationModule': {'nctId': 'NCT07356050', 'acronym': 'VALID', 'briefTitle': 'Verifying Antibodies After Live Immunization Delivery (VALID): A Study of Measles Vaccine Immunogenicity in Children With Sickle Cell Disease', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital Medical Center, Cincinnati"}, 'officialTitle': 'Verifying Antibodies After Live Immunization Delivery (VALID): a Study of Measles Vaccine Immunogenicity in Children With Sickle Cell Disease', 'orgStudyIdInfo': {'id': 'VALID'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Second Measles Vaccine (MV2)', 'description': 'Participants who receive second measles vaccine.'}, {'label': 'First Measles Vaccine (MV1)', 'description': 'Participants who obtain the first measles vaccine.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'MacKenzie Tasset', 'role': 'CONTACT', 'email': 'MacKenzie.Tasset@cchmc.org', 'phone': '513-803-4856'}, {'name': 'Charles Quinn, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Cincinnati Children's Hospital Medical Center", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'city': 'Accra', 'state': 'Ghana', 'status': 'RECRUITING', 'country': 'Ghana', 'contacts': [{'name': 'Teresa Latham', 'role': 'CONTACT', 'email': 'Teresa.Latham@cchmc.org', 'phone': '513-803-7922'}, {'name': 'Catherine Segbefia, MBChB, FWACP, GGCPS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Korle Bu Teaching Hospital', 'geoPoint': {'lat': 5.55602, 'lon': -0.1969}}, {'city': 'Mwanza', 'status': 'RECRUITING', 'country': 'Tanzania', 'contacts': [{'name': 'Teresa Latham, PhD', 'role': 'CONTACT', 'email': 'Teresa.Latham@cchmc.org', 'phone': '513-803-7922'}, {'name': 'Emmanuela Ambrose, MD, MMED', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Bugando Medical Centre', 'geoPoint': {'lat': -2.51667, 'lon': 32.9}}], 'centralContacts': [{'name': 'Teresa Latham', 'role': 'CONTACT', 'email': 'Teresa.Latham@cchmc.org', 'phone': '513-803-7922'}, {'name': 'Amy Shova', 'role': 'CONTACT', 'email': 'Amy.Shova@cchmc.org', 'phone': '(513) 803-1917'}], 'overallOfficials': [{'name': 'Alexandra Power-Hays, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital Medical Center, Cincinnati"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital Medical Center, Cincinnati", 'class': 'OTHER'}, 'collaborators': [{'name': 'Thrasher Research Fund', 'class': 'OTHER'}, {'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}