Vaccination for patients without a spleen
Immunogenicity and Safety of a Meningococcal Serogroup B Vaccine in Adult Patients with Asplenia
This study is testing if the meningococcal B vaccine is safe and effective for people who don’t have a spleen compared to healthy individuals.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Medical University of Vienna Academic / other |
| Drugs / interventions | Rituximab, chemotherapy, prednisone |
| Locations | 1 site (Vienna, State of Vienna) |
| Trial ID | NCT06025487 on ClinicalTrials.gov |
What this trial studies
This phase II pilot study evaluates the immunogenicity and safety of the meningococcal B vaccine (BEXSERO®) in patients who have undergone splenectomy or have functional asplenia. A total of 40 asplenic patients and 40 healthy controls will receive two doses of the vaccine, administered one month apart. The study aims to measure the antibody response against different meningococcal strains in the blood of participants, comparing the results between the asplenic group and healthy controls. Participants will undergo four study visits to assess immunogenicity and monitor for any adverse events.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 60 who are asplenic due to splenectomy or functional asplenia.
Not a fit: Patients who are pregnant, lactating, or have had recent febrile illnesses or allergic reactions to vaccinations may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide critical data on the effectiveness of the meningococcal B vaccine in protecting asplenic patients from severe infections.
How similar studies have performed: While studies on meningococcal vaccines exist, this specific approach focusing on asplenic patients is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Vienna, State of Vienna
- Medical University Vienna — Vienna, State of Vienna, Austria (Recruiting)
Study contacts
- Principal investigator: Nicole Harrison, Dr. — Medical University Vienna
- Study coordinator: Nicole Harrison, Dr.
- Email: nicole.harrison@meduniwien.ac.at
- Phone: +43 1 40400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.