RecruitingPhase 3NCT04166656

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

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


Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

84 participants

Start Date

Sep 15, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria7

  • 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.

Exclusion Criteria13

  • 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.

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Interventions

BIOLOGICALTrumenba®

Trumenba® (Pfizer): Suspension for intramuscular injection in 0.5 mL single-dose prefilled.

BIOLOGICALBexsero®

Bexsero® (GSK): available as a suspension for intramuscular injection in a prefilled syringe


Locations(1)

I-REIVAC/CIC1417 Cochin Hospital, AP-HP

Paris, France

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NCT04166656


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