Actively Recruiting
Immunogenicity and Safety of a Meningococcal Serogroup B Vaccine in Adult Patients with Asplenia
Led by Medical University of Vienna · Updated on 2024-11-22
80
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Patients without a spleen have a higher risk of serious infections from certain bacteria, especially meningococcal bacteria of serogroup B, which is common in Europe. This research evaluates the meningococcal B vaccine called BEXSERO4 in adults with asplenia compared to healthy adults. The goal is to understand how well the vaccine triggers immune responses and to gather safety information for this high-risk group. Participants include 40 patients without a spleen and 40 healthy controls, each receiving two doses of BEXSERO4 injected into the muscle, spaced one month apart. The study includes four visits: before vaccination, one month after the second dose, and six months later. Researchers will measure immune responses using blood tests that detect antibodies and assess immune cell activity. The study also tracks any adverse reactions after vaccination. During the study, participants will provide blood samples to measure antibody levels against three meningococcal strains using a special laboratory assay considered the gold standard. The study evaluates both antibody levels and cellular immune responses. Safety is monitored by documenting all side effects. The study lasts at least six months after vaccination to observe the persistence of immunity and overall vaccine safety in this population.
CONDITIONS
Brief Title
Meningococcal B Vaccine in Patients with Asplenia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- For asplenic patients: asplenia due to splenectomy or functional asplenia
- Age between 18 and 60 years
- If female, negative urine pregnancy test at study entry and agreement to use birth control during the study
- Providing written informed consent
- For healthy controls: age between 18 and 60 years
- If female, negative urine pregnancy test at study entry and agreement to use birth control during the study
- Providing written informed consent
You will not qualify if you...
- Pregnant or lactating
- Febrile illness within two weeks before enrollment
- History of allergic reactions to vaccination
- Chemotherapy with Rituximab within the last six months or during the study
- Use of more than 20mg prednisone daily within four weeks prior or at enrollment
- Previous vaccination against meningococcal serogroup B
- For healthy controls: any immunosuppressive condition or medication
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - 1 month between doses
Participants receive two doses of the meningococcal B vaccine (Bexsero) intramuscularly with a one-month interval between doses.
4 visits: baseline vaccination, second vaccination one month later, and follow-up visits one month and six months after second vaccination
Trial Site Locations
Total: 1 location
1
Medical University Vienna
Vienna, State of Vienna, Austria, 1090
Actively Recruiting
Research Team
N
Nicole Harrison, Dr.
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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