Splenectomy; Status Clinical Trial
Official title:
Immunogenicity and Safety of a Meningococcal Serogroup B Vaccine in Adult Patients With Asplenia
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.
Status | Not yet recruiting |
Enrollment | 80 |
Est. completion date | June 1, 2025 |
Est. primary completion date | June 1, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | 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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Medical University of Vienna |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Humoral immunogenicity | Immunogenicity will be assessed by human serum bactericidal antibody assay (hSBA) against three vaccine antigens (PorA, fHbp and NadA). The primary end point is the mean log-titre over the three meningococcal strains (NZ98/254 for PorA, 5/99 for NadA and 44/76-SL for fHbp) as measured by the hSBA one month after second vaccination.
The non-inferiority margin was set to a 2-fold titre difference between the geometric mean titre of the asplenic group and the healthy control group. |
one month after second vaccination | |
Secondary | Persistence of humoral immunity | The persistence of antibodies six months after second vaccination as measured by hSBA | six months after second vaccination | |
Secondary | Cellular immunogenicity - lymphocyte proliferation | The cellular immune response as measured by lymphocyte proliferation assay | one month after second vaccination | |
Secondary | Cellular Immunogenicity - cytokine levels | The cellular immune response as measured by cytokine levels using Luminex | one month after second vaccination | |
Secondary | Adverse Events | Evaluation of safety by documenting all adverse events after vaccination | four weeks after first and second vaccination |
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