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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-000924-17 | EudraCT Number |
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| Name | Class |
|---|---|
| EUCLID Clinical Trial Platform | OTHER |
| Recherche Clinique Paris Descartes Necker Cochin Sainte Anne | OTHER |
| CIC 1417 Cochin-Pasteur | OTHER |
| Innovative clinical research in vaccinologie (I-REIVAC) |
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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.
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.
As 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. .
That 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Arm B:Bexsero®: standard vaccination regimen | Other | Two doses of 0.5 ml each at one month intervals |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trumenba® | Biological | Trumenba® (Pfizer): Suspension for intramuscular injection in 0.5 mL single-dose prefilled. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity | Immunogenicity at M2/M7, i.e. one month after the completeness of each vaccine strategy:
| one month after the completeness of each vaccine strategy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| Odile LAUNAY, MD,PhD | CIC 1417 Clinical Center Investigation | Principal Investigator |
| MUHAMED-KHEIR TAHA, MD, PHD | Institut Pasteur | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| I-REIVAC/CIC1417 Cochin Hospital, AP-HP | Recruiting | Paris | 75014 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22947250 | Background | 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. | |
| 23954380 | 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. |
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| ID | Term |
|---|---|
| C000729870 | MenB-FHbp vaccine |
| C570015 | 4CMenB vaccine |
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| UNKNOWN |
| Institut Pasteur | INDUSTRY |
| URC-CIC Paris Descartes Necker Cochin | OTHER |
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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.
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| Bexsero® | Biological | Bexsero® (GSK): available as a suspension for intramuscular injection in a prefilled syringe |
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| Persistence of immunogenicity | Persistence of immunogenicity at M12 M24, M36 and M48 for each vaccine strategy
| At M12 M24, M36 and M48 |
| Modeling of the determinants of immunogenicity | Modeling of the determinants of immunogenicity: reason for splenectomy, age, gender, immunosuppressive or immunomodulatory agent | during the trial |
| Any event or serious adverse event | Any event or serious adverse event during the trial possibly or not related to vaccine immunization. | 7 days following each vaccination. |
| safety and effectiveness | To assess safety and effectiveness of Bexsero® and Trumenba® in asplenic adults older than 65 years of age. | through study completion |
| 19534597 | 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. |
| 14688112 | 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. |
| 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. |
| 24722351 | 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. |
| 18714044 | 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. |
| 10820247 | 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. |
| 74605 | 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. |
| 4977280 | 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. |