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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
84
I-REIVAC/CIC1417 Cochin Hospital, AP-HP
Paris, France
RECRUITINGProportion 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.
Time frame: One month after the completeness of three anti-meningococci B vaccine strategies (at M7 for all arms) in asplenic adults.
Immunogenicity
Immunogenicity at M2/M7, i.e. one month after the completeness of each vaccine strategy: * Serum bactericidal antibody (hSBA) Geometric Mean Titer (GMT). * Proportion of responding participants using the conservative threshold of 8. * Proportion of participants achieving an hSBA titer equal to or greater than the lower limit of quantification of the assay.
Time frame: one month after the completeness of each vaccine strategy
Persistence of immunogenicity
Persistence of immunogenicity at M12 M24, M36 and M48 for each vaccine strategy * Serum bactericidal antibody (hSBA), GMT. * Proportion of responding participants using the conservative threshold of 8. * Proportion of participants achieving an SBA titre equal to or greater than the lower limit of quantification of the assay.
Time frame: 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
Time frame: 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.
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Time frame: 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.
Time frame: through study completion