Research Trial Assessing the Immunogenicity and Safety of Three Meningococcal B Vaccine Strategies Among Patients With Asplenia.

Recruiting now · Phase 3

Conditions studied: Splenectomy

In brief

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.

Key facts

Study ID: NCT04166656
Run by: Assistance Publique - Hôpitaux de Paris
People needed: 84
Starts: 2022-09-15
Expected to finish: 2028-10-01
Last updated by the study team: 2025-11-20

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

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

Full record on ClinicalTrials.gov

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