Actively Recruiting
Meningococcal B Vaccine in Patients with Asplenia
Led by Medical University of Vienna · Updated on 2024-11-22
80
Participants Needed
1
Research Sites
94 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Patients without a spleen (asplenia) experience an increased risk for septicaemia from encapsulated bacteria, which is associated with a high mortality rate. Meningococcal bacteria can cause such infections and serogroup B is the dominant meningococcal subtype in Europe. Therefore, vaccination for risk populations like patients without a spleen is a pressing matter. Considering the effectiveness of the meningococcal serogroup B vaccine, data for this high-at-risk population is currently lacking. The aim of this study is to evaluate the meningococcal B vaccine (BEXSERO®) in patients without a spleen compared to a healthy control group. A total of 40 patients and 40 healthy persons will receive a two-dose schedule of BEXSERO® with a one-month interval between doses. The effectiveness of the vaccine will be determined by measuring antibodies against different meningococcal strains in the blood of the patient. The amount of antibodies one month after second vaccination will be compared between patients and healthy persons. The most reliable assay to determine antibodies against meningococcal strains is the human serum bactericidal assay which will be carried out in a reference laboratory. Other end points are the persistence of antibodies after six months and the cellular immune response. The cellular immune response will be assessed by measuring the proliferation of certain immune cells like lymphocytes and the amount of produced cytokines (signalling proteins) after vaccination. In addition, the safety of the vaccine will be evaluated by documenting all adverse reactions to the vaccine. Overall, this study will be the first to assess the effectiveness of the meningococcal B vaccine in this high-at-risk population and provide data for vaccination guidelines.
CONDITIONS
Official Title
Meningococcal B Vaccine in Patients with Asplenia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Asplenia due to splenectomy or functional asplenia (for patient group)
- Age between 18 and 60 years (for both patients and healthy controls)
- If female, negative urine pregnancy test at study entry and agreement to use effective birth control during the study
- Written informed consent provided
You will not qualify if you...
- Pregnant or breastfeeding
- Fever or febrile illness within two weeks before enrollment
- History of allergic reactions to vaccinations
- Chemotherapy with Rituximab within six months before or during the study (patients only)
- Taking more than 20 mg prednisone daily within four weeks before or at enrollment (patients only)
- Previous vaccination against meningococcal serogroup B
- Immunosuppressive condition or medication (healthy controls only)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Medical University Vienna
Vienna, State of Vienna, Austria, 1090
Actively Recruiting
Research Team
N
Nicole Harrison, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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