Ignite Creation Date:
2025-12-24 @ 11:20 PM
Ignite Modification Date:
2026-02-21 @ 9:56 PM
Study NCT ID:
NCT04166656
Status:
RECRUITING
Last Update Posted:
2025-11-20
First Post:
2019-08-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Research Trial Assessing the Immunogenicity and Safety of Three Meningococcal B Vaccine Strategies Among Patients With Asplenia.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000729870', 'term': 'MenB-FHbp vaccine'}, {'id': 'C570015', 'term': '4CMenB vaccine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'The trial will be open label. However, the assessment of the primary and secondary immunological endpoints will be carried out blind from the treatment arm.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 84}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2028-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2019-08-29', 'studyFirstSubmitQcDate': '2019-11-14', 'lastUpdatePostDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2019-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of responders defined as participants with seroconversion', 'timeFrame': 'One month after the completeness of three anti-meningococci B vaccine strategies (at M7 for all arms) in asplenic adults.', 'description': 'Proportion of responders defined as participants with seroconversion (i.e. hSBA titer increases from \\<4 before vaccination to at least 4) or with hSBA titer showing a 4-fold increase (if hSBA titer was at least 4 before vaccination) one month after the completeness of three anti-meningococci B vaccine strategies (at M7 for all arms) in asplenic adults.'}], 'secondaryOutcomes': [{'measure': 'Immunogenicity', 'timeFrame': 'one month after the completeness of each vaccine strategy', 'description': 'Immunogenicity at M2/M7, i.e. one month after the completeness of each vaccine strategy:\n\n* Serum bactericidal antibody (hSBA) Geometric Mean Titer (GMT).\n* Proportion of responding participants using the conservative threshold of 8.\n* Proportion of participants achieving an hSBA titer equal to or greater than the lower limit of quantification of the assay.'}, {'measure': 'Persistence of immunogenicity', 'timeFrame': 'At M12 M24, M36 and M48', 'description': 'Persistence of immunogenicity at M12 M24, M36 and M48 for each vaccine strategy\n\n* Serum bactericidal antibody (hSBA), GMT.\n* Proportion of responding participants using the conservative threshold of 8.\n* Proportion of participants achieving an SBA titre equal to or greater than the lower limit of quantification of the assay.'}, {'measure': 'Modeling of the determinants of immunogenicity', 'timeFrame': 'during the trial', 'description': 'Modeling of the determinants of immunogenicity: reason for splenectomy, age, gender, immunosuppressive or immunomodulatory agent'}, {'measure': 'Any event or serious adverse event', 'timeFrame': '7 days following each vaccination.', 'description': 'Any event or serious adverse event during the trial possibly or not related to vaccine immunization.'}, {'measure': 'safety and effectiveness', 'timeFrame': 'through study completion', 'description': 'To assess safety and effectiveness of Bexsero® and Trumenba® in asplenic adults older than 65 years of age.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Meningococcal B vaccine', 'vaccine strategies', 'splenectomized individuals'], 'conditions': ['Splenectomy']}, 'referencesModule': {'references': [{'pmid': '22947250', 'type': 'BACKGROUND', 'citation': 'Borrow R. Advances with vaccination against Neisseria meningitidis. Trop Med Int Health. 2012 Dec;17(12):1478-91. doi: 10.1111/j.1365-3156.2012.03085.x. Epub 2012 Sep 4.'}, {'pmid': '23954380', 'type': 'BACKGROUND', 'citation': 'Frosi G, Biolchi A, Lo Sapio M, Rigat F, Gilchrist S, Lucidarme J, Findlow J, Borrow R, Pizza M, Giuliani MM, Medini D. Bactericidal antibody against a representative epidemiological meningococcal serogroup B panel confirms that MATS underestimates 4CMenB vaccine strain coverage. Vaccine. 2013 Oct 9;31(43):4968-74. doi: 10.1016/j.vaccine.2013.08.006. Epub 2013 Aug 14.'}, {'pmid': '19534597', 'type': 'BACKGROUND', 'citation': 'Murphy E, Andrew L, Lee KL, Dilts DA, Nunez L, Fink PS, Ambrose K, Borrow R, Findlow J, Taha MK, Deghmane AE, Kriz P, Musilek M, Kalmusova J, Caugant DA, Alvestad T, Mayer LW, Sacchi CT, Wang X, Martin D, von Gottberg A, du Plessis M, Klugman KP, Anderson AS, Jansen KU, Zlotnick GW, Hoiseth SK. Sequence diversity of the factor H binding protein vaccine candidate in epidemiologically relevant strains of serogroup B Neisseria meningitidis. J Infect Dis. 2009 Aug 1;200(3):379-89. doi: 10.1086/600141.'}, {'pmid': '14688112', 'type': 'BACKGROUND', 'citation': 'Balmer P, Falconer M, McDonald P, Andrews N, Fuller E, Riley C, Kaczmarski E, Borrow R. Immune response to meningococcal serogroup C conjugate vaccine in asplenic individuals. Infect Immun. 2004 Jan;72(1):332-7. doi: 10.1128/IAI.72.1.332-337.2004.'}, {'type': 'BACKGROUND', 'citation': "5. Hcsp. Avis du hcsp relatif à l'utilisation du vaccin bexsero® (novartis vaccines and diagnostics). 2013. (link:http://www.hcsp.fr/explore.cgi/telecharger?nomfichier=hcspa20131025_vaccmeningocoquebbexsero®.pdf."}, {'pmid': '24722351', 'type': 'BACKGROUND', 'citation': 'McQuaid F, Snape MD, John TM, Kelly S, Robinson H, Houlden J, Voysey M, Toneatto D, Kitte C, Dull PM, Pollard AJ. Persistence of bactericidal antibodies to 5 years of age after immunization with serogroup B meningococcal vaccines at 6, 8, 12 and 40 months of age. Pediatr Infect Dis J. 2014 Jul;33(7):760-6. doi: 10.1097/INF.0000000000000327.'}, {'pmid': '18714044', 'type': 'BACKGROUND', 'citation': 'Wasserstrom H, Bussel J, Lim LC, Cunningham-Rundles C. Memory B cells and pneumococcal antibody after splenectomy. J Immunol. 2008 Sep 1;181(5):3684-9. doi: 10.4049/jimmunol.181.5.3684.'}, {'pmid': '10820247', 'type': 'BACKGROUND', 'citation': 'Mori M, Morris SC, Orekhova T, Marinaro M, Giannini E, Finkelman FD. IL-4 promotes the migration of circulating B cells to the spleen and increases splenic B cell survival. J Immunol. 2000 Jun 1;164(11):5704-12. doi: 10.4049/jimmunol.164.11.5704.'}, {'pmid': '74605', 'type': 'BACKGROUND', 'citation': 'Sullivan JL, Ochs HD, Schiffman G, Hammerschlag MR, Miser J, Vichinsky E, Wedgwood RJ. Immune response after splenectomy. Lancet. 1978 Jan 28;1(8057):178-81. doi: 10.1016/s0140-6736(78)90612-8.'}, {'pmid': '4977280', 'type': 'BACKGROUND', 'citation': 'Goldschneider I, Gotschlich EC, Artenstein MS. Human immunity to the meningococcus. I. The role of humoral antibodies. J Exp Med. 1969 Jun 1;129(6):1307-26. doi: 10.1084/jem.129.6.1307.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate the immunological response and tolerance of 3 vaccine strategies against meningococcus B, a potentially fatal invasive infection.', 'detailedDescription': 'Currently, in France, no immunogenicity data on Meningococcal B vaccines, neither with Bexsero® nor with Trumenba®, are available in asplenic patients, population at high risk of infection.\n\nAs asplenic individuals (all causes) show less optimal immune response to conjugate meningococcal C vaccine compared to matched controls. \\[4\\], we hypothesize that a similar less optimal response may be expected for MenB vaccines among asplenic subjects. .\n\nThat is why, we proposed in this study to evaluate two reinforced strategies with 3 administrations (M0, M1, and M6) of Bexsero® or Trumenba ®. Moreover, the study will also allow exploring the persistence of the immune response in this population. Indeed, few data are available on this persistence in the general population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female, \\>=18 to \\<=75 years old.\n2. Asplenic patient (for at least 2 weeks) with Howell Jolly bodies visible on blood film\n3. Splenectomy confirmed by consultation and/or hospitalization report or the ultrasound if it has been performed during the routine follow-up\n4. Women of childbearing age must have an effective contraception during the first 9 months of the study.\n5. Participants must give written consent prior to any trial procedure\n6. Participants must be covered by social security regimen or equivalent.\n7. Participants will be followed during the 4 years from the inclusion visit.\n\nExclusion Criteria:\n\n1. History of meningococcal vaccination B.\n2. History of anaphylaxis post vaccination.\n3. Known allergy to any components (active substances or excipients) of both vaccines.\n4. Patients who cannot stop antibiotics 3 days before blood collection.\n5. Participants who have received any another vaccines within 4 weeks prior to immunization or who are planning to receive any vaccine within the first 7 months of the study (except the meningococcal ACWY vaccine, the anti-pneumococcal vaccine, the Haemophilus influenzae type B vaccine, the anti-Covid-19 vaccine), annual influenza vaccination which is permitted 2 weeks before and after each vaccination visit of the study and then allowed at any time during the study follow up).\n6. Parenteral Ig within the 3 months prior to VS or planned during the study.\n7. Chemotherapy agents within 6 months prior M0 or planning to take any during the study.\n8. Steroids (\\> 10mg/day; \\> 14 days) within the month preceding M0 or planning to take any during the study.\n9. Any pathology or condition that may impair the immune response, apart from splenectomy: immunosuppressive therapy in progress or in the 6 months prior to inclusion, hematopoietic stem cells allo / autograft, primary immunodeficiency, nephrotic syndrome, evolutive cancer, cirrhosis, known infection to HIV;\n10. Thrombocytopenia or any coagulation disorder contra-indicating intramuscularly injections.\n11. Pregnancy, breastfeeding or positive pregnancy test up to 7 months after inclusion.\n12. Severe acute febrile illness within the week before inclusion.\n13. Registration for any other clinical trial throughout the trial period except observational study.'}, 'identificationModule': {'nctId': 'NCT04166656', 'acronym': 'SPLEMENGO', 'briefTitle': 'Research Trial Assessing the Immunogenicity and Safety of Three Meningococcal B Vaccine Strategies Among Patients With Asplenia.', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Multicenter, Randomized, Phase III, Trial Assessing the Immunogenicity and Safety of Three Meningococcal B Vaccine Strategies Among Patients With Asplenia', 'orgStudyIdInfo': {'id': 'P170938J'}, 'secondaryIdInfos': [{'id': '2019-000924-17', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Arm A : Trumenba®: Standard vaccination', 'description': 'Two doses of 0.5 ml each at one month intervals, followed by a third dose given at 6 months after the second dose.', 'interventionNames': ['Biological: Trumenba®']}, {'type': 'OTHER', 'label': 'Arm B:Bexsero®: standard vaccination regimen', 'description': 'Two doses of 0.5 ml each at one month intervals', 'interventionNames': ['Biological: Bexsero®']}, {'type': 'OTHER', 'label': 'Arm C : Bexsero® Innovative vaccine strategy', 'description': 'Two doses of 0.5 ml each at one month intervals, followed by a third dose given at 6 months after the second dose.', 'interventionNames': ['Biological: Bexsero®']}], 'interventions': [{'name': 'Trumenba®', 'type': 'BIOLOGICAL', 'description': 'Trumenba® (Pfizer): Suspension for intramuscular injection in 0.5 mL single-dose prefilled.', 'armGroupLabels': ['Arm A : Trumenba®: Standard vaccination']}, {'name': 'Bexsero®', 'type': 'BIOLOGICAL', 'description': 'Bexsero® (GSK): available as a suspension for intramuscular injection in a prefilled syringe', 'armGroupLabels': ['Arm B:Bexsero®: standard vaccination regimen', 'Arm C : Bexsero® Innovative vaccine strategy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75014', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Odile LAUNAY, MD,PhD', 'role': 'CONTACT', 'email': 'odile.launay@aphp.fr', 'phone': '+33(01)58 41 28 58'}, {'name': 'Mouna Fellague Chebra, project manager', 'role': 'CONTACT', 'email': 'mouna.fellaguechebra@aphp.fr', 'phone': '+33 (0)1 58 41 33 54'}, {'name': 'Odile LAUNAY, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'I-REIVAC/CIC1417 Cochin Hospital, AP-HP', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Odile LAUNAY, MD,PhD', 'role': 'CONTACT', 'email': 'odile.launay@aphp.fr', 'phone': '+33(01)58 41 28 58'}, {'name': 'Audrey BECLIN-CLABAUX', 'role': 'CONTACT', 'email': 'audrey.clabaux@aphp.fr', 'phone': '+33 (0)1 58 41 33 82'}], 'overallOfficials': [{'name': 'Odile LAUNAY, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CIC 1417 Clinical Center Investigation'}, {'name': 'MUHAMED-KHEIR TAHA, MD, PHD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Institut Pasteur'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'EUCLID Clinical Trial Platform', 'class': 'OTHER'}, {'name': 'Recherche Clinique Paris Descartes Necker Cochin Sainte Anne', 'class': 'OTHER'}, {'name': 'CIC 1417 Cochin-Pasteur', 'class': 'OTHER'}, {'name': 'Innovative clinical research in vaccinologie (I-REIVAC)', 'class': 'UNKNOWN'}, {'name': 'Institut Pasteur', 'class': 'INDUSTRY'}, {'name': 'URC-CIC Paris Descartes Necker Cochin', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}