Actively Recruiting
Research Trial Assessing the Immunogenicity and Safety of Three Meningococcal B Vaccine Strategies Among Patients With Asplenia.
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-11-20
84
Participants Needed
1
Research Sites
315 weeks
Total Duration
On this page
Sponsors
A
Assistance Publique - Hôpitaux de Paris
Lead Sponsor
E
EUCLID Clinical Trial Platform
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Research Trial Assessing the Immunogenicity and Safety of Three Meningococcal B Vaccine Strategies Among Patients With Asplenia.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 to 75 years
- Asplenic for at least 2 weeks with Howell Jolly bodies visible on blood film
- Splenectomy confirmed by medical report or ultrasound
- Women of childbearing age must use effective contraception during the first 9 months of the study
- Provide written consent before any trial procedures
- Covered by social security or equivalent
- Willing to be followed for 4 years after inclusion
You will not qualify if you...
- Previous meningococcal B vaccination
- History of anaphylaxis after vaccination
- Known allergy to any vaccine components
- Unable to stop antibiotics 3 days before blood collection
- Received any other vaccine within 4 weeks before immunization or planning other vaccines within 7 months, except certain allowed vaccines
- Received parenteral immunoglobulins within 3 months before study or planned during study
- Chemotherapy within 6 months before study or planned during study
- Steroid use over 10 mg/day for more than 14 days within 1 month before study or planned during study
- Conditions impairing immune response other than splenectomy, such as immunosuppressive therapy, stem cell transplant, primary immunodeficiency, nephrotic syndrome, active cancer, cirrhosis, or HIV infection
- Thrombocytopenia or bleeding disorders contraindicating intramuscular injections
- Pregnancy, breastfeeding, or positive pregnancy test up to 7 months after inclusion
- Severe acute fever within 1 week before inclusion
- Participation in another clinical trial during this study period except observational studies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
I-REIVAC/CIC1417 Cochin Hospital, AP-HP
Paris, France, 75014
Actively Recruiting
Research Team
O
Odile LAUNAY, MD,PhD
CONTACT
A
Audrey BECLIN-CLABAUX
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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