Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2025-12-29 @ 2:29 AM
Study NCT ID:
NCT07194668
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-19
First Post:
2025-09-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
R21/MM Dosing, Presentations, and Preservatives
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016778', 'term': 'Malaria, Falciparum'}, {'id': 'D008288', 'term': 'Malaria'}], 'ancestors': [{'id': 'D011528', 'term': 'Protozoan Infections'}, {'id': 'D010272', 'term': 'Parasitic Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000096724', 'term': 'Mosquito-Borne Diseases'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 375}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-14', 'studyFirstSubmitDate': '2025-09-02', 'studyFirstSubmitQcDate': '2025-09-18', 'lastUpdatePostDateStruct': {'date': '2025-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Assays to assess presence or absence of other factors potentially affecting vaccine immunogenicity', 'timeFrame': 'Month 0, Month 3, Month 11 and Month 12'}], 'primaryOutcomes': [{'measure': 'The concentration of antibodies against Plasmodium falciparum circumsporozoite (anti-NANP total IgG antibody)', 'timeFrame': 'One month after the completion of the third dose (at M3), and one month after the booster dose (at M12).'}, {'measure': 'The concentration of antibodies against Plasmodium falciparum circumsporozoite (anti C-Term, and full length R21 total IgG antibody), in addition to total IgG against Hepatitis B surface antigen', 'timeFrame': 'One month after the completion of the third dose (at M3), and one month after the booster dose (at M12).'}], 'secondaryOutcomes': [{'measure': 'Adverse event and severe adverse event reports for safety and tolerability assessment of the standard adult vaccine dose 10μg R21/50μg Matrix-M and a half of the standard adult dose 5μg R21/50μg Matrix-M', 'timeFrame': 'At Month 1, Month 2, Month 3, Month 11 and Month 12'}, {'measure': 'Adverse event and severe adverse event reports for safety and tolerability assessment a half of the standard adult dose 5μg R21/50μg Matrix-M with 2PE preservative vs, without 2PE preservative.', 'timeFrame': 'At Month 1, Month 2, Month 3, Month 11 and Month 12'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Plasmodium Falciparum Malaria', 'Malaria Vaccine'], 'conditions': ['Plasmodium Falciparum Malaria', 'Malaria', 'Vaccine Reaction']}, 'descriptionModule': {'briefSummary': 'This is a single blind randomised controlled trial. This study aims to assess whether a half-dose of the R21/Matrix-M malaria vaccine is as effective as the full dose in child and adults. The results will help optimize vaccine usage and improve malaria prevention strategies.\n\nAll participants will receive the same number of injections and will be randomly assigned to receive one of the followings:\n\n1. The standard dose (10μg R21/50μg Matrix-M) of the malaria vaccine is administered in three doses over a two-month period (at Month 0, 1, and 2), followed by a booster dose at Month 11 (n=125).\n\n or\n2. A half dose (5μg R21/50μg Matrix-M) of the malaria vaccine is administered in three doses over a two-month period (at Month 0, 1, and 2), followed by a booster dose at Month 11.\n\nIf participant receive the half dose, it will come from one of two types of vaccine:\n\n2a. 10 dose vials with adaptor Preservative Free (n=125) 2b. 10 dose vials with 2PE Preservative (n=125)\n\nClinical procedure for participants:\n\n* Standardized symptom questionnaire\n* Physical examination:\n\n * Weight, height, pulse, blood pressure, respiratory rate, tympanic temperature.\n * Spleen and liver size will be recorded if palpable.\n * Pregnancy test (for female of child bearing potential)\n* Venous blood collection (Pre-vaccination) 3mL\n* Vaccination'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '14 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Residence in a study village for the study period, i.e. 12 months.\n* Age 14 years to 60 years.\n* Written informed consent/assent provided by participants (or a parent/guardian in case the participant is under 18 years old).\n\nExclusion Criteria:\n\n* Pregnancy, plan to get pregnant within one month of vaccination, or breastfeeding.\n* Acute illness requiring intervention.\n* A history of an adverse reaction to study vaccine.\n* Prior receipt of any other malaria vaccine.\n* Enrolment in another intervention trial in the last month.\n* Planned enrolment in another intervention trial in the coming 12 months.\n* Regular use of Immunomodulating drugs e.g, Steroid, Methotrexate, Immunotherapy etc. in the past month and/or planned for the coming 12 months.'}, 'identificationModule': {'nctId': 'NCT07194668', 'acronym': 'VAC100', 'briefTitle': 'R21/MM Dosing, Presentations, and Preservatives', 'organization': {'class': 'OTHER', 'fullName': 'University of Oxford'}, 'officialTitle': 'Immunogenicity of a Fractional Adult Dose of the Malaria Vaccine R21/Matrix-M - A Noninferiority Trial', 'orgStudyIdInfo': {'id': 'MAL25005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'The standard adult vaccine dose', 'description': 'Adults and adolescents receiving the standard adult vaccine dose', 'interventionNames': ['Biological: 10μg R21/50μg Matrix-M']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'A half of the standard adult vaccine dose with adaptor Preservative Free', 'description': 'Adults and adolescents receiving a half of the standard adult vaccine dose with adaptor Preservative Free (n=125)', 'interventionNames': ['Biological: 5μg R21/50μg Matrix-M with adaptor preservative free']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'A half of the standard adult vaccine dose with 2PE Preservative', 'description': 'Adults and adolescents receiving a half of the standard adult vaccine dose with 2PE Preservative (n=125)', 'interventionNames': ['Biological: 5μg R21/50μg Matrix-M with 2PE preservative']}], 'interventions': [{'name': '10μg R21/50μg Matrix-M', 'type': 'BIOLOGICAL', 'description': 'Adults and adolescents receiving the standard adult vaccine dose: 10μg R21/50μg Matrix-M (n=125)', 'armGroupLabels': ['The standard adult vaccine dose']}, {'name': '5μg R21/50μg Matrix-M with adaptor preservative free', 'type': 'BIOLOGICAL', 'description': 'Adults and adolescents receiving a half of the standard adult vaccine dose: 5μg R21/50μg Matrix-M using two presentations: 10 dose vials with adaptor Preservative Free (n=125)', 'armGroupLabels': ['A half of the standard adult vaccine dose with adaptor Preservative Free']}, {'name': '5μg R21/50μg Matrix-M with 2PE preservative', 'type': 'BIOLOGICAL', 'description': 'Adults and adolescents receiving a half of the standard adult vaccine dose: 5μg R21/50μg Matrix-M using two presentations: 10 dose vials with 2PE Preservative (n=125)', 'armGroupLabels': ['A half of the standard adult vaccine dose with 2PE Preservative']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4641', 'city': 'Lāma', 'state': 'Lama', 'country': 'Bangladesh', 'contacts': [{'name': 'Mohammad Abul Faiz', 'role': 'CONTACT', 'email': 'drmafaiz@gmail.com', 'phone': '+008801613008857'}], 'facility': 'Lama Upazila Health Complex', 'geoPoint': {'lat': 21.77439, 'lon': 92.21907}}, {'zip': '4650', 'city': 'Bāndarban', 'country': 'Bangladesh', 'contacts': [{'name': 'Mohammad Abul Faiz', 'role': 'CONTACT', 'email': 'drmafaiz@gmail.com', 'phone': '+008801613008857'}], 'facility': 'Alikadam Upazila Health Complex', 'geoPoint': {'lat': 22.19534, 'lon': 92.21946}}], 'centralContacts': [{'name': 'Lorenz von Seidlein', 'role': 'CONTACT', 'email': 'Lorenz@tropmedres.ac', 'phone': '+66926486322'}, {'name': 'Rupam Tripura', 'role': 'CONTACT', 'email': 'Rupam@tropmedres.ac', 'phone': '+8801572288558'}]}, 'ipdSharingStatementModule': {'infoTypes': ['ICF', 'CSR'], 'ipdSharing': 'YES', 'description': "With participant's consent, participant's data and results from blood analyses stored in the database may be shared according to the terms defined in the MORU data sharing policy (https://www.tropmedres.ac/units/moru-bangkok/bioethics-engagement/data-sharing/moru-tropical-network-policy-on-sharing-data-and-other-outputs)with data repositories such as the WorldWide Antimalarial Resistance Network (WWARN, terms of submission here: http://www.wwarn.org/tools-resources/terms-submission) or other researchers to use in the future. All personal information will be anonymised so that no individual can be identified from their treatment records, through interviews, or from mapping data."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oxford', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}