Splenectomy; StatusPhase 2NCT06025487
Meningococcal B Vaccine in Patients with Asplenia
A Phase 2 study testing Bexsero in people with Splenectomy; Status, run by Medical University of Vienna at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Splenectomy; Status
- What is being tested?
- Bexsero
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteAustria
- Study dates
- 12 Mar 2024to 31 Dec 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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:
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
Medical University Vienna
Vienna, State of Vienna, 1090
Nicole Harrison, +4314040044400
About this study
Official title: Immunogenicity and Safety of a Meningococcal Serogroup B Vaccine in Adult Patients with Asplenia
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.
Read the 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 NZ98/254), fHbp (strain 44/76-SL) and NadA (strain 5/99). 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 ≥1:4 is considered as a correlate for protection against meningococcal disease. 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. To investigate cellular immunity following meningococcal vaccination, lymphocyte proliferation and cytokine detection assays will be used.
- Conditions
- Splenectomy; Status
- Being tested
- Bexsero
- Keywords
- Asplenia, Meningococcal disease, Meningococcal B vaccine
- Medical subject headings
- Meningococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BexseroBiological
two doses of Bexsero are applied intramuscularly with a one-month interval between doses
| Study group | Role | What they receive |
|---|---|---|
| Patients | Active comparator | Asplenic patients receiving two doses of Bexsero (meningococcal B vaccine) with one-month interval between doses Receives: Biological: Bexsero |
| Healthy controls | Active comparator | Healthy controls receiving two doses of Bexsero (meningococcal B vaccine) with one-month interval between doses Receives: Biological: Bexsero |
What is being measured
The primary outcome is the main question the study is designed to answer.
Humoral immunogenicity
Immunogenicity will be assessed by human serum bactericidal antibody assay (hSBA) against three vaccine antigens (PorA, fHbp and NadA). 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.
Measured: one month after second vaccination
Secondary outcomes (4)
Persistence of humoral immunity
The persistence of antibodies six months after second vaccination as measured by hSBA
Measured: six months after second vaccination
Cellular immunogenicity - lymphocyte proliferation
The cellular immune response as measured by lymphocyte proliferation assay
Measured: one month after second vaccination
Cellular Immunogenicity - cytokine levels
The cellular immune response as measured by cytokine levels using Luminex
Measured: one month after second vaccination
Adverse Events
Evaluation of safety by documenting all adverse events after vaccination
Measured: four weeks after first and second vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2023
- Study start12 Mar 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Splenectomy; StatusStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- prospective open-label phase II study comparing patients and healthy controls
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicole Harrison, Medical University of Vienna
- Investigators
- Nicole Harrison, Dr., Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06025487
- Sponsor's protocol ID
- MenB_Asplenia
- Other IDs
- 2022-001451-16
- Status last verified
- Nov 2024
- First submitted
- 23 Aug 2023
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety of a Meningococcal Serogroup B Vaccine in Adult Patients with Asplenia
- ClinicalTrials.gov ID
- NCT06025487
- Acronym / sponsor ID
- MenB_Asplenia
- Conditions
- Splenectomy; Status
- Keywords
- Asplenia, Meningococcal disease, Meningococcal B vaccine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 12 Mar 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 6 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 NZ98/254), fHbp (strain 44/76-SL) and NadA (strain 5/99). 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 ≥1:4 is considered as a correlate for protection against meningococcal disease. 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. To investigate cellular immunity following meningococcal vaccination, lymphocyte proliferation and cytokine detection assays will be used.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- prospective open-label phase II study comparing patients and healthy controls
| Arm | Type | Receives |
|---|---|---|
| Patients | Active comparator | Biological: BexseroAsplenic patients receiving two doses of Bexsero (meningococcal B vaccine) with one-month interval between doses |
| Healthy controls | Active comparator | Biological: BexseroHealthy controls receiving two doses of Bexsero (meningococcal B vaccine) with one-month interval between doses |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
- 18 to 60 years of age
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bexserotwo doses of Bexsero are applied intramuscularly with a one-month interval between doses | Biological | Healthy controls, Patients |
Primary outcome
Humoral immunogenicity
Time frame: one month after second vaccination
Immunogenicity will be assessed by human serum bactericidal antibody assay (hSBA) against three vaccine antigens (PorA, fHbp and NadA). 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.
4 secondary outcomes
Persistence of humoral immunity
Time frame: six months after second vaccination
Cellular immunogenicity - lymphocyte proliferation
Time frame: one month after second vaccination
Cellular Immunogenicity - cytokine levels
Time frame: one month after second vaccination
Adverse Events
Time frame: four weeks after first and second vaccination
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nicole Harrison, Dr. principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bexsero in people with Splenectomy; Status, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicole Harrison, Dr. (+43 1 40400 ext. 44400, nicole.harrison@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Humoral immunogenicity (time frame: one month after second vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2024.