Research Trial Assessing the Immunogenicity and Safety of Three Meningococcal B Vaccine Strategies Among Patients With Asplenia.

NCT04166656 | Recruiting Phase 3

• 2 other identifiers: P170938J2019-000924-17
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Splenectomy

Keywords

Meningococcal B vaccine; vaccine strategies; splenectomized individuals

Outcome Measures

Primary Outcomes (1)

• Proportion of responders defined as participants with seroconversion

  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.

  One month after the completeness of three anti-meningococci B vaccine strategies (at M7 for all arms) in asplenic adults.

Secondary Outcomes (5)

• Immunogenicity

  one month after the completeness of each vaccine strategy

• Persistence of immunogenicity

  At M12 M24, M36 and M48

• Modeling of the determinants of immunogenicity

  during the trial

• Any event or serious adverse event

  7 days following each vaccination.

• safety and effectiveness

  through study completion

Study Arms (3)

Arm A : Trumenba®: Standard vaccination

OTHER

Two doses of 0.5 ml each at one month intervals, followed by a third dose given at 6 months after the second dose.

Biological: Trumenba®

Arm B:Bexsero®: standard vaccination regimen

OTHER

Two doses of 0.5 ml each at one month intervals

Biological: Bexsero®

Arm C : Bexsero® Innovative vaccine strategy

OTHER

Two doses of 0.5 ml each at one month intervals, followed by a third dose given at 6 months after the second dose.

Biological: Bexsero®

Interventions

Trumenba® BIOLOGICAL

Trumenba® (Pfizer): Suspension for intramuscular injection in 0.5 mL single-dose prefilled.

Arm A : Trumenba®: Standard vaccination

Bexsero® BIOLOGICAL

Bexsero® (GSK): available as a suspension for intramuscular injection in a prefilled syringe

Arm B:Bexsero®: standard vaccination regimen; Arm C : Bexsero® Innovative vaccine strategy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, \>=18 to \<=75 years old.
• Asplenic patient (for at least 2 weeks) with Howell Jolly bodies visible on blood film
• Splenectomy confirmed by consultation and/or hospitalization report or the ultrasound if it has been performed during the routine follow-up
• Women of childbearing age must have an effective contraception during the first 9 months of the study.
• Participants must give written consent prior to any trial procedure
• Participants must be covered by social security regimen or equivalent.

You may not qualify if:

• History of meningococcal vaccination B.
• History of anaphylaxis post vaccination.
• Known allergy to any components (active substances or excipients) of both vaccines.
• Patients who cannot stop antibiotics 3 days before blood collection.
• 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).
• Parenteral Ig within the 3 months prior to VS or planned during the study.
• Chemotherapy agents within 6 months prior M0 or planning to take any during the study.
• Steroids (\> 10mg/day; \> 14 days) within the month preceding M0 or planning to take any during the study.
• Thrombocytopenia or any coagulation disorder contra-indicating intramuscularly injections.
• Registration for any other clinical trial throughout the trial period except observational study.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• EUCLID Clinical Trial Platform: collaborator
• Recherche Clinique Paris Descartes Necker Cochin Sainte Anne: collaborator
• CIC 1417 Cochin-Pasteur: collaborator
• Innovative clinical research in vaccinologie (I-REIVAC): collaborator
• Institut Pasteur: collaborator
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

I-REIVAC/CIC1417 Cochin Hospital, AP-HP

Paris, 75014, France

RECRUITING

Related Publications (10)

• 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: 22947250 BACKGROUND

• 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: 23954380 BACKGROUND

• 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: 19534597 BACKGROUND

• 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.

  PMID: 14688112 BACKGROUND

• 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.

  BACKGROUND

• 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: 24722351 BACKGROUND

• 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: 18714044 BACKGROUND

• 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: 10820247 BACKGROUND

• 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: 74605 BACKGROUND

• 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.

  PMID: 4977280 BACKGROUND

MeSH Terms

Interventions

MenB-FHbp vaccine; 4CMenB vaccine

Study Officials

• Odile LAUNAY, MD,PhD

  CIC 1417 Clinical Center Investigation

  PRINCIPAL INVESTIGATOR

• MUHAMED-KHEIR TAHA, MD, PHD

  Institut Pasteur

  STUDY DIRECTOR

Central Study Contacts

Odile LAUNAY, MD,PhD

CONTACT

+33(01)58 41 28 58; odile.launay@aphp.fr

Audrey BECLIN-CLABAUX

CONTACT

+33 (0)1 58 41 33 82; audrey.clabaux@aphp.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2019
• First Posted: November 18, 2019
• Study Start: September 15, 2022
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: November 20, 2025

Record last verified: 2025-10

Locations

FR (1)