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.
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.
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.
Parallel
Trumenba®
Biological/VaccineTrumenba® (Pfizer): Suspension for intramuscular injection in 0.5 mL single-dose prefilled.
Bexsero®
Biological/VaccineBexsero® (GSK): available as a suspension for intramuscular injection in a prefilled syringe
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.
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.
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.
Modeling of the determinants of immunogenicity
Modeling of the determinants of immunogenicity: reason for splenectomy, age, gender, immunosuppressive or immunomodulatory agent
Any event or serious adverse event
Any event or serious adverse event during the trial possibly or not related to vaccine immunization.
Click on the lead sponsor to view all of their trials.
Assistance Publique - Hôpitaux de Paris
Lead sponsor
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
