RECOMBINANT NEISSERIA MENINGITIDIS GROUP B NHBA FUSION PROTEIN; RECOMBINANT NEISSERIA MENINGITIDIS GROUP B NADA PROTEIN; RECOMBINANT NEISSERIA MENINGITIDIS GROUP B FHBP FUSION PROTEIN; OUTER MEMBRANE VESICLES (OMV) FROM NEISSERIA MENINGITIDIS GROUP B STRAIN NZ98/254 (measured as amount of total protein containing the PorA P1.4) (all adsorbed on aluminium hydroxide) for Asplenia

Inclusion criteria

• {"criterion_text":"- asplenia due to splenectomy or functional asplenia (only patients)\n- 18 to 60 years of age\n- 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\n- providing written informed consent"}

Exclusion criteria

• {"criterion_text":"- previous vaccination against meningococcal serogroup B\n- pregnant or lactating\n- febrile illness within last two weeks prior to enrolment\n- allergic reactions to vaccination in past\n- chemotherapy with Rituximab within last six months or during study period (only patients)\n- more than 20mg prednisone per day within last four weeks prior or at the time of enrolment (only patients)\n- any immunosuppressive condition or medication (only healthy controls)"}

Primary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Measured by human serum bactericidal antibody assay (hSBA) one month after second vaccination; non-inferiority margin = 2-fold difference between geometric mean titres of asplenic vs healthy control group."}

Secondary endpoints

• {"endpoint_text":"- The persistence of antibodies will be measured six months after second vaccination and the difference between the means of the log-titers between the asplenic and the control group will be calculated.","definition_or_measurement_approach":"Antibody persistence measured six months after second vaccination; difference between means of log-titres calculated between groups."}
• {"endpoint_text":"- The cellular immune response as measured by lymphocyte proliferation assay and cytokine levels.","definition_or_measurement_approach":"Cellular response assessed by lymphocyte proliferation assay and measurement of cytokine (interleukin) levels at baseline and one month after second vaccination."}
• {"endpoint_text":"- Adverse events (AEs) during the observation period will be tabulated by single events with the number of the vaccination, the type of the event, its severity and evaluation concerning its relation to the vaccination, potential treatment and sequelae.","definition_or_measurement_approach":"AEs tabulated by event, vaccination number, type, severity, relation to vaccination, treatment and sequelae."}

Methods

• Healthy controls recruited mostly among health care workers and medical students (no other recruitment channels specified in available documents)

Austria

Earliest CTIS Part Ii Submission Date

05-01-2024

Latest Decision Or Authorization Date

02-01-2025

Processing Time Days

363

Number Of Sites

1

Number Of Participants

80

Primary sponsor

Full Name

Medical University of Vienna

Organisation Type

Educational Institution

Country Of Registered Address

Austria

Third parties

• {"country":"","full_name":"Austrian Science Fund","duties_or_roles":"Monetary support","organisation_type":"Other"}