Meningococcal vaccines

Assistance Publique – Hôpitaux de Paris

Odile LAUNAY MD, PhD-AP-HP

Currently, in France, no immunogenicity data on Meningococal 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, 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.

Multicenter, randomized, national, open label, phase II clinical trial

To assess immunogenicity one month after the completeness of three anti-meningococci B vaccine strategies (at M7 for all arms), in asplenic adults.

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.

Asplenic adults

Arm A : Trumenba® at M0, M1 and M6 (standard vaccination regimen)
Arm B : Bexsero® at M0, M1(standard vaccination regimen)
Arm C : Bexsero® at M0, M1, M6 (innovative vaccine strategy)

84 participants

France, 13 sites

72 months

French Ministry of Health (PHRC-N)

Methodology and Statistical aspects

https://clinicaltrials.gov/ct2/show/NCT04166656