Status:
RECRUITING
Meningococcal B Vaccine in Patients with Asplenia
Lead Sponsor:
Medical University of Vienna
Conditions:
Splenectomy; Status
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief 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 infe...
Detailed Description
This study is a prospective open-label phase II pilot study to assess the immunogenicity and safety of BEXSERO® in asplenic patients. Patients participating in the study will complete a total of four ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 12 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06025487
Start Date
March 12 2024
End Date
December 31 2025
Last Update
November 22 2024
Active Locations (1)
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1
Medical University Vienna
Vienna, Vienna, Austria, 1090