Ignite Creation Date:
2024-05-06 @ 7:28 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06025487
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-09-06
First Post:
2023-08-23
Brief Title:
Meningococcal B Vaccine in Patients With Asplenia
Sponsor:
Medical University of Vienna
Organization:
Medical University of Vienna
Study Overview
Official Title:
Immunogenicity and Safety of a Meningococcal Serogroup B Vaccine in Adult Patients With Asplenia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 infections and serogroup B is the dominant meningococcal subtype in Europe Therefore vaccination for risk populations like patients without a spleen is a pressing matter Considering the effectiveness of the meningococcal serogroup B vaccine data for this high-at-risk population is currently lacking The aim of this study is to evaluate the meningococcal B vaccine BEXSERO in patients without a spleen compared to a healthy control group A total of 40 patients and 40 healthy persons will receive a two-dose schedule of BEXSERO with a one-month interval between doses The effectiveness of the vaccine will be determined by measuring antibodies against different meningococcal strains in the blood of the patient The amount of antibodies one month after second vaccination will be compared between patients and healthy persons The most reliable assay to determine antibodies against meningococcal strains is the human serum bactericidal assay which will be carried out in a reference laboratory Other end points are the persistence of antibodies after six months and the cellular immune response The cellular immune response will be assessed by measuring the proliferation of certain immune cells like lymphocytes and the amount of produced cytokines signalling proteins after vaccination In addition the safety of the vaccine will be evaluated by documenting all adverse reactions to the vaccine Overall this study will be the first to assess the effectiveness of the meningococcal B vaccine in this high-at-risk population and provide data for vaccination guidelines
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 study visits A two dose schedule of BEXSERO will be applied intramuscularly with a one month interval between doses Seropositivity will be assessed at baseline during the first visit one month and six months after the second vaccination Basic demographic data gender age and medical data type of asplenia time of splenectomy underlying diseases concurrent medical conditions medication etc will be entered into a case report form CRF During the second and third visit all adverse events will be entered into the CRF and severe adverse events SAEs will be reported accordingly Patients who have either been splenectomised or suffer from functional asplenia will be recruited for this study during their routine vaccination visit at the out-patient ward for infectious diseases of the Medical University of Vienna A total of 40 patients and 40 healthy controls will be recruited for this study The null hypothesis states that the immunogenicity of the meningococcal B vaccine is inferior in asplenic patients compared to a healthy control group Immunogenicity will be assessed by human serum bactericidal antibody assay hSBA against three vaccine antigens The human serum bactericidal antibody assay hSBA will be carried out in a reference laboratory Meningococcal Reference Unit Health Protection Agency North West Laboratory Manchester Royal Infirmary United Kingdom to determine functional antibodies against three meningococcal vaccine antigens PorA strain NZ98254 fHbp strain 4476-SL and NadA strain 599 The hSBA measures complement mediated killing of Neisseria meningitidis by vaccine-induced antibodies It is considered as the gold standard for measuring antibody response against meningococcal bacteria Currently the detection of antibodies by hSBA with a titre of 14 is considered as a correlate for protection against meningococcal disease The primary end point is the mean log-titre over the three meningococcal strains NZ98254 for PorA 599 for NadA and 4476-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 To investigate cellular immunity following meningococcal vaccination lymphocyte proliferation and cytokine detection assays will be used
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2022-001451-16 | EUDRACT_NUMBER | None | None |