Ignite Creation Date:
2025-12-26 @ 4:01 PM
Ignite Modification Date:
2025-12-30 @ 5:52 AM
Study NCT ID:
NCT06667206
Status:
RECRUITING
Last Update Posted:
2024-10-31
First Post:
2023-12-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Earlier Prime-BOOST Schedule to Improve MEasles Protection in High Burden Settings
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008457', 'term': 'Measles'}], 'ancestors': [{'id': 'D018185', 'term': 'Morbillivirus Infections'}, {'id': 'D018184', 'term': 'Paramyxoviridae Infections'}, {'id': 'D018701', 'term': 'Mononegavirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'All participants receive the same vaccines but are randomised to the timing of administration of the vaccines.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Equal numbers of participants are randomised to 3 arms.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 450}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2026-05-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-29', 'studyFirstSubmitDate': '2023-12-19', 'studyFirstSubmitQcDate': '2024-10-29', 'lastUpdatePostDateStruct': {'date': '2024-10-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Public perceptions of measles immunisation', 'timeFrame': 'Baseline until 2 year follow up visit', 'description': 'Focus group interviews with the public and parents/guardians of enrolled children'}], 'primaryOutcomes': [{'measure': 'Protective measles antibody concentrations at 2.5 years of age', 'timeFrame': '2.5 years of age', 'description': 'Proportion of participants with protective levels of measles neutralising antibodies (PRNT\\>120mIUL)'}, {'measure': 'Local and systemic reactions', 'timeFrame': '7 days post each vaccination', 'description': 'Reactogenicity profile from diary cards'}, {'measure': 'Serious Adverse Events', 'timeFrame': '2 years: (from baseline vaccination until 2 year follow up visit)'}], 'secondaryOutcomes': [{'measure': 'Measles plaque reduction neutralisation titre (PRNT) and immunoglobulin G (IgG) concentration', 'timeFrame': 'one month after first dose', 'description': 'Measles PRNT and IgG concentrations one month after first dose in infants receiving an early (6 months) compared to standard (9 month) dose of MCV'}, {'measure': 'The effect of maternal human immunodeficiency virus (HIV) infection', 'timeFrame': 'one month after first dose and second dose', 'description': 'Infant PRNT and IgG responses post MCV1 and MCV2 in children of mothers with and without HIV'}, {'measure': 'The effect of maternal antibodies on infant immune response', 'timeFrame': 'pre-vaccination, 4 weeks after the first dose, 4 weeks after the second dose', 'description': 'Relationship between baseline titres (pre vaccination) and 4 week post-vaccination titres for PRNT, Measles IgG, and measles ELISpot.'}, {'measure': 'Immune response to rubella component of the vaccine', 'timeFrame': '4 weeks after a first and second dose', 'description': 'Anti-rubella IgG'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['measles-rubella vaccine'], 'conditions': ['Measles']}, 'descriptionModule': {'briefSummary': 'This is a phase IIb clinical trial investigating the non-inferiority of immune responses in children given two doses of measles vaccine at different timepoints. The study will randomise 450 children to 3 groups: group A will receive measles containing vaccine (MCV) at 6 and 12 months ; group B at 9 and 18 months; Group C at 6 and 18 months.', 'detailedDescription': 'Two doses of measles containing vaccine (MCV) are recommended in young children with the first dose given at different times depending on the setting. In low-incidence settings the MCV1 is given at 12 months of age or later as more infants over 12 months of age respond to MCV1 due to the absence of maternal antibody interference and an overall better immune response due to the maturation of the infant immune system. In high measles incidence settings MCV1 is given earlier at 9 months of age as there is no remaining protection from maternal antibody at this age and risk of infection if unvaccinated can be high. However, in children born with low levels or rapid decay of maternal antibody, the 9-month timing for MCV1 means the infant may be susceptible to infection for some months prior to vaccination. Therefore, in settings of high infant measles incidence, an early first dose at 6 months of age may bridge this susceptibility gap.\n\nOur study will assess differences in protective levels of measles antibody in children randomised to receive early (6 months) or standard (9 months) MCV1 in a high incidence measles setting, and early (12 months) or standard (18 months) booster vaccines, in those who are given early MCV1. There will be 5 blood draws over 2 years. The study will compare children who received a) two doses of measles vaccine at 6 and 18 months with 9 and 18 months, and b) two doses of measles vaccine at 6 and 12 months compared with 6 and 18 months.\n\nThe study is funded by the Bill \\& Melinda Gates Foundation (INV-048650)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '28 Weeks', 'minimumAge': '23 Weeks', 'healthyVolunteers': True, 'eligibilityCriteria': "1. Trial Participants Children aged 6 months (23 - 28 weeks) at time of screening\n2. Inclusion Criteria\n\n * Aged 6 months (23 - 28 weeks) at time of screening\n * Received all previous vaccines as per country Expanded Programme of Immunization (EPI) schedule, verified by child health card\n * Parents/caretakers willing to give informed consent for their and their children's participation and stay in the geographical area where the study would be conducted\n3. Exclusion Criteria\n\nThe participant may not enter the trial if any of the following apply:\n\n* Child not healthy enough to be vaccinated in the opinion of the investigator\n* Recent family history of measles infection (since birth)\n* Previous receipt of any measles vaccination\n* A family history of congenital or hereditary immunodeficiency other than HIV\n* Receipt of more than 1 week of immunosuppressant or immune modifying drugs e.g. high dose steroids.\n* Major congenital defects or serious chronic illness that in the opinion of the investigator are likely to modify immune responses or the ability to comply with the requirements of the study.\n* History of any neurological disorders or seizures\n* Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period\n* Other abnormalities or medical history that contraindicated measles vaccination"}, 'identificationModule': {'nctId': 'NCT06667206', 'acronym': 'BoostMe', 'briefTitle': 'Earlier Prime-BOOST Schedule to Improve MEasles Protection in High Burden Settings', 'organization': {'class': 'OTHER', 'fullName': 'University of Oxford'}, 'officialTitle': 'Earlier Prime-BOOST Schedule to Improve MEasles Protection in High Burden Settings', 'orgStudyIdInfo': {'id': 'OVG2022/06'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A: 6 and 12 months', 'description': 'Early Prime-Boost schedule: Measles vaccines given at 6 and 12 months of age', 'interventionNames': ['Biological: Licenced Measles-Rubella vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'Group B: 9 and 18 months (standard schedule)', 'description': 'Standard schedule: Measles vaccines given at 9 and 18 months of age', 'interventionNames': ['Biological: Licenced Measles-Rubella vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'Group C: 6 and 18 months', 'description': 'Early Prime schedule: Measles vaccines given at 6 and 18 months of age', 'interventionNames': ['Biological: Licenced Measles-Rubella vaccine']}], 'interventions': [{'name': 'Licenced Measles-Rubella vaccine', 'type': 'BIOLOGICAL', 'description': 'Licenced Measles-Rubella vaccine provided by the Ugandan EPI programme', 'armGroupLabels': ['Group A: 6 and 12 months', 'Group B: 9 and 18 months (standard schedule)', 'Group C: 6 and 18 months']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kampala', 'status': 'RECRUITING', 'country': 'Uganda', 'contacts': [{'name': 'Kirsty Le Doare', 'role': 'CONTACT'}], 'facility': 'Makarere University - Johns Hopkins University Collaboration', 'geoPoint': {'lat': 0.31628, 'lon': 32.58219}}], 'centralContacts': [{'name': 'Oxford Vaccine Group', 'role': 'CONTACT', 'email': 'info@ovg.ox.ac.uk', 'phone': '01865 611400'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oxford', 'class': 'OTHER'}, 'collaborators': [{'name': "St George's, University of London", 'class': 'OTHER'}, {'name': 'MU-JHU CARE', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}