Vaccination for patients without a spleen

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Medical University Vienna
  Vienna, State of Vienna, Austria Recruiting

Study contacts

• Principal investigator: Nicole Harrison, Dr. — Medical University of Vienna
• Study coordinator: Nicole Harrison, Dr.
• Email: nicole.harrison@meduniwien.ac.at
• Phone: +43 1 40400

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Laparoscopic splenectomy's effect on liver function in cirrhosis patients

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.