Meningococcal B Vaccine in Patients with Asplenia
Immunogenicity and Safety of a Meningococcal Serogroup B Vaccine in Adult Patients with Asplenia
Medical University of Vienna
80 participants
Mar 12, 2024
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria9
- For asplenic patients:
- asplenia due to splenectomy or functional asplenia
- to 60 years of age
- if female: have a negative urine pregnancy test result at study entry and agree to employ adequate birth control measures for the duration of the study
- providing written informed consent
- For healthy controls:
- to 60 years of age
- if female: have a negative urine pregnancy test result at study entry and agree to employ adequate birth control measures for the duration of the study
- providing written informed consent
Exclusion Criteria13
- For asplenic patients:
- pregnant or lactating
- febrile illness within last two weeks prior to enrolment
- allergic reactions to vaccination in past
- chemotherapy with Rituximab within last six months or during study period
- more than 20mg prednisone per day within last four weeks prior or at the time of enrolment
- previous vaccination against meningococcal serogroup B
- For healthy controls:
- pregnant or lactating
- febrile illness within last two weeks prior to enrolment
- allergic reactions to vaccination in past
- any immunosuppressive condition or medication
- previous vaccination against meningococcal serogroup B
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Interventions
two doses of Bexsero are applied intramuscularly with a one-month interval between doses
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06025487