Research Trial Assessing the Immunogenicity and Safety of Three Meningococcal B Vaccine Strategies Among Patients With Asplenia.
- Conditions
- Splenectomy
- Interventions
- Biological: Trumenba®Biological: Bexsero®
- Registration Number
- NCT04166656
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 84
- 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.
- Participants must give written consent prior to any trial procedure
- Participants must be covered by social security regimen or equivalent.
- Participants will be followed during the 4 years from the inclusion visit.
- 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.
- Participants who have received any another vaccines within 4 weeks prior to immunization or who are planning to receive any vaccine within the first 7 months of the study (except the meningococcal ACWY vaccine, the anti-pneumococcal vaccine, the Haemophilus influenzae type B vaccine, the anti-Covid-19 vaccine), annual influenza vaccination which is permitted 2 weeks before and after each vaccination visit of the study and then allowed at any time during the study follow up).
- Parenteral Ig within the 3 months prior to VS or planned during the study.
- Chemotherapy agents within 6 months prior M0 or planning to take any during the study.
- Steroids (> 10mg/day; > 14 days) within the month preceding M0 or planning to take any during the study.
- 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;
- Thrombocytopenia or any coagulation disorder contra-indicating intramuscularly injections.
- Pregnancy, breastfeeding or positive pregnancy test up to 7 months after inclusion.
- Severe acute febrile illness within the week before inclusion.
- Registration for any other clinical trial throughout the trial period except observational study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A : Trumenba®: Standard vaccination Trumenba® Two doses of 0.5 ml each at one month intervals, followed by a third dose given at 6 months after the second dose. Arm C : Bexsero® Innovative vaccine strategy Bexsero® Two doses of 0.5 ml each at one month intervals, followed by a third dose given at 6 months after the second dose. Arm B:Bexsero®: standard vaccination regimen Bexsero® Two doses of 0.5 ml each at one month intervals
- Primary Outcome Measures
Name Time Method Proportion of responders defined as participants with seroconversion 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.
- Secondary Outcome Measures
Name Time Method Persistence of immunogenicity At M12 M24, M36 and M48 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.Any event or serious adverse event 7 days following each vaccination. Any event or serious adverse event during the trial possibly or not related to vaccine immunization.
Modeling of the determinants of immunogenicity during the trial Modeling of the determinants of immunogenicity: reason for splenectomy, age, gender, immunosuppressive or immunomodulatory agent
safety and effectiveness through study completion To assess safety and effectiveness of Bexsero® and Trumenba® in asplenic adults older than 65 years of age.
Immunogenicity one month after the completeness of each vaccine strategy 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.
Trial Locations
- Locations (1)
I-REIVAC/CIC1417 Cochin Hospital, AP-HP
🇫🇷Paris, France