Overview
Sponsor-declared trial summary
Splenectomy
To demonstrate that the immunogenicity of the meningococcal serogroup B vaccine BEXSERO® is non-inferior in asplenic patients compared to a healthy control group, measured by human serum bactericidal antibody assay one month after second vaccination.
Key facts
- Sponsor
- Medical University of Vienna
- Participant type
- Healthy volunteers, Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Bacterial Infections and Mycoses [C01]
- Trial duration
- 5 Mar 2024 → ongoing
- Decision date (initial)
- 2024-02-05
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Austrian Science Fund
External identifiers
- EU CT number
- 2023-508192-36-00
- WHO UTN
- U1111-1297-8468
- ClinicalTrials.gov
- NCT06025487
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Others
To demonstrate that the immunogenicity of the meningococcal serogroup B vaccine BEXSERO® is non-inferior in asplenic patients compared to a healthy control group, measured by human serum bactericidal antibody assay one month after second vaccination.
Secondary objectives 3
- To assess the persistence of antibodies six months after second vaccination in asplenic patients compared to healthy controls.
- To assess the cellular immune response by lymphocyte proliferation assay and measurement of interleukins in asplenic patients compared to healthy controls at baseline and one month after second vaccination.
- To assess the safety of the vaccine in asplenic patients
Conditions and MedDRA coding
Splenectomy
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10041642 | Splenectomy | 100000004865 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- asplenia due to splenectomy or functional asplenia (only patients)
- 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 7
- previous vaccination against meningococcal serogroup B
- 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 (only patients)
- more than 20mg prednisone per day within last four weeks prior or at the time of enrolment (only patients)
- any immunosuppressive condition or medication (only healthy controls)
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- 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.
Secondary endpoints 3
- 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.
- The cellular immune response as measured by lymphocyte proliferation assay and cytokine levels.
- 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.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD2149122 · Product
- Active substance
- Recombinant Neisseria Meningitidis Group B Nhba Fusion Protein Produced in E. Coli Cells by Recombinant DNA Technology Adsorbed on Aluminium Hydroxide
- Pharmaceutical form
- SUSPENSION FOR INJECTION
- Route of administration
- INTRAMUSCULAR INJECTION
- Max daily dose
- 0.5 ml millilitre(s)
- Max total dose
- 1 ml millilitre(s)
- Max treatment duration
- 5 Week(s)
- Authorisation status
- Authorised
- ATC code
- J07AH09 — -
- Marketing authorisation
- EU/1/12/812/001
- MA holder
- GSK VACCINES S.R.L.
- MA country
- Liechtenstein
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Medical University of Vienna
- Sponsor organisation
- Medical University of Vienna
- Address
- Waehringer Guertel 18-20, Alsergrund Alsergrund
- City
- Vienna
- Postcode
- 1090
- Country
- Austria
Scientific contact point
- Organisation
- Medical University of Vienna
- Contact name
- Department of Medicine I Division of Infectious Diseases and Tropical Medicine
Public contact point
- Organisation
- Medical University of Vienna
- Contact name
- Department of Medicine I Division of Infectious Diseases and Tropical Medicine
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruitment ended | 80 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Austria | 2024-03-05 | 2024-03-12 | 2026-04-09 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 4 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Redacted | 1 |
| Subject information and informed consent form (for publication) | D4_Patient diary_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults_Redacted | 5 |
| Subject information and informed consent form (for publication) | L2_information poster_Redacted | 1 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-10-17 | Austria | Acceptable 2024-01-12
|
2024-02-05 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2024-02-15 | Austria | Acceptable 2024-01-12
|
2024-02-15 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-01-02 | Austria | Acceptable 2024-01-12
|
2025-01-02 |