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Meningococcal B Vaccine in Patients with Asplenia

RecruitingPhase 2Ages 18 Years - 60 YearsAllMedical University of Vienna
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In plain words

What the trial is, and whether it could suit you

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 bl

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📋 Eligibility rules (as published)
Inclusion Criteria: For asplenic patients: * asplenia due to splenectomy or functional asplenia * 18 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: * 18 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 Criteria: 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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What it tests

  • Bexsero
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Where

1 site
Medical University Vienna
Vienna, Austria
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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