asplenic patients at risk for invasive meningococcal disease MedDRA version: 20.0 Level: PT Classification code 10041642 Term: Splenectomy System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Trade Name: Bexsero®
Pharmaceutical Form: Solution for injection
Trade Name: Trumenba®
Pharmaceutical Form: Solution for injection
Sponsors
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female, >=18 to =65 years) yes F.1.3.1 Number of subjects for this age range 24
Exclusion criteria
Exclusion criteria: 1. History of meningococcal vaccination. 2. History of anaphylaxis post vaccination. 3. Known allergy to any components (active substances or excipients) of both vaccines. 4. Patients who cannot stop antibiotics 7 to 10 days before blood collection. 5. Participants who have received any another vaccines within 4 weeks prior to immunization or who are planning to receive any vaccine within the first 9 months of the study (excepted annual influenza vaccination which is permitted 4 weeks before and after each vaccination visit of the study and then allowed at any time during the study follow up). 6. Parenteral Ig within the 3 months prior to VS or planned during the study. 7. Chemotherapy agents within 6 months prior M0 or planning to take any during the study. 8. Steroids (> 10mg/day; > 14 days) within the month preceding M0 or planning to take any during the study. 9. Any pathology or condition that may impair the immune response, apart from splenectomy: immunosuppressive therapy in progress or in the 6 months prior to inclusion, hematopoietic stem cells allo /autograft, primary immunodeficiency, nephrotic syndrome, evolutive cancer, cirrhosis, known infection to HIV; 10. Thrombocytopenia or any coagulation disorder contra-indicating intramuscularly injections. 11. Pregnancy, breastfeeding or positive pregnancy test up to 9 months after inclusion. 12. Severe acute febrile illness within the week before inclusion. 13. Registration for any other clinical trial throughout the trial period except observational study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this trial is to assess immunogenicity one month after the completeness of three anti-meningococci B vaccine strategies (at M7 for all arms), in asplenic adults.;Secondary Objective: 1. To evaluate for each vaccine strategy, the immunogenicity one month after the completeness of the vaccination scheme (M2/M7) (GMT, proportion of responders to the threshold of 8) in asplenic adults. 2. To assess persistence and evolution of immune response until 48 months post 1st immunization for each vaccine strategy in asplenic adults (at M12, M24, and M36 and M48). 3. To assess determinants of immune response to each vaccine strategy in asplenic adults. 4. To evaluate, for each vaccine strategy, clinical and biological safety of the vaccines in asplenic adults. 5. To assess safety and effectiveness of Bexsero® and Trumenba® in asplenic adults older than 65 years of age;Primary end point(s): 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 antimeningococci B vaccine strategies (at M7 for all arms) in asplenic adults.;Timepoint(s) of evaluation of this end point: at Month 7 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. 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. 2. 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. 3. Modeling of the determinants of immunogenicity: reason for splenectomy, age, gender, immunosuppressive or immunomodulatory agent. 4. Safety: Proportion of participant with an event (number, nature, grade and time of occurrence) - Local and/or systemic solicited reactions 7 days following each vaccination. - Any event or serious adverse event during the trial possibly or not related to vaccine immunization. 5. To assess safety and effectiveness of Bexsero® and Trumenba® in asplenic adults older than 65 years of age.;Timepoint(s) of evaluation of this end point: at M2, M7, M12, M25, M36 and M48 | — |
Countries
France
Contacts
Public ContactDRCI Hôpital Saint-Louis
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS
Outcome results
None listed