Research Trial Assessing the Immunogenicity and Safety of Three Meningococcal B Vaccine Strategie… (NCT04166656) | Clinical Trial Compass
RecruitingPhase 3
Research Trial Assessing the Immunogenicity and Safety of Three Meningococcal B Vaccine Strategies Among Patients With Asplenia.
France84 participantsStarted 2022-09-15
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. 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).
What they're measuring
1
Proportion of responders defined as participants with seroconversion
Timeframe: One month after the completeness of three anti-meningococci B vaccine strategies (at M7 for all arms) in asplenic adults.