Assessing Meningococcal B Vaccine Strategies for Patients Without a Spleen

Multicenter, Randomized, Phase III, Trial Assessing the Immunogenicity and Safety of Three Meningococcal B Vaccine Strategies Among Patients With Asplenia

This study is testing different ways to give Meningococcal B vaccines to people without a spleen to see which method works best and how long the protection lasts.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 84 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Assistance Publique - Hôpitaux de Paris (Academic / other)
• Drugs / interventions: Chemotherapy
• Locations: 1 site (Paris)
• Trial ID: NCT04166656 on ClinicalTrials.gov

What this trial studies

This study evaluates the immune response and safety of three different strategies for administering Meningococcal B vaccines (Bexsero® and Trumenba®) in patients who have undergone splenectomy. It aims to determine the effectiveness of these vaccine strategies in asplenic individuals, who are at a higher risk for invasive infections. The study will involve administering the vaccines at three different time points and will also investigate how long the immune response lasts in this vulnerable population. The findings could provide critical data on the immunogenicity of these vaccines in asplenic patients, where current data is lacking.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 75 who have undergone splenectomy and have Howell Jolly bodies present in their blood.

Not a fit: Patients with a history of meningococcal vaccination B or those with known allergies to the vaccine components may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance vaccine strategies for asplenic patients, potentially reducing their risk of severe infections.

How similar studies have performed: While there is limited data on Meningococcal B vaccines in asplenic patients, similar studies have shown the importance of tailored vaccination strategies in high-risk populations.

Eligibility criteria

Inclusion Criteria:

1. Male or female, \>=18 to \<=75 years old.
2. Asplenic patient (for at least 2 weeks) with Howell Jolly bodies visible on blood film
3. Splenectomy confirmed by consultation and/or hospitalization report or the ultrasound if it has been performed during the routine follow-up
4. Women of childbearing age must have an effective contraception during the first 9 months of the study.
5. Participants must give written consent prior to any trial procedure
6. Participants must be covered by social security regimen or equivalent.
7. Participants will be followed during the 4 years from the inclusion visit.

Exclusion Criteria:

1. History of meningococcal vaccination B.
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 3 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 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).
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 7 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.

Where this trial is running

Paris

• I-REIVAC/CIC1417 Cochin Hospital, AP-HP — Paris, France (Recruiting)

Study contacts

• Principal investigator: Odile LAUNAY, MD,PhD — CIC 1417 Clinical Center Investigation
• Study coordinator: Odile LAUNAY, MD,PhD

Conditions Splenectomy; Meningococcal B vaccine; vaccine strategies; splenectomized individuals