Meningococcal B Vaccine in Patients with Asplenia

NCT06025487 | Recruiting Phase 2

• 2 other identifiers: MenB_Asplenia2022-001451-16
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Splenectomy; Status

Keywords

Asplenia; Meningococcal disease; Meningococcal B vaccine

Outcome Measures

Primary Outcomes (1)

• 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.

  one month after second vaccination

Secondary Outcomes (4)

• Persistence of humoral immunity

  six months after second vaccination

• Cellular immunogenicity - lymphocyte proliferation

  one month after second vaccination

• Cellular Immunogenicity - cytokine levels

  one month after second vaccination

• Adverse Events

  four weeks after first and second vaccination

Study Arms (2)

Patients

ACTIVE COMPARATOR

Asplenic patients receiving two doses of Bexsero (meningococcal B vaccine) with one-month interval between doses

Biological: Bexsero

Healthy controls

ACTIVE COMPARATOR

Healthy controls receiving two doses of Bexsero (meningococcal B vaccine) with one-month interval between doses

Biological: Bexsero

Interventions

Bexsero BIOLOGICAL

two doses of Bexsero are applied intramuscularly with a one-month interval between doses

Healthy controls; Patients

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• For asplenic patients:
• asplenia due to splenectomy or functional asplenia
• 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:
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University Vienna

Vienna, Vienna, 1090, Austria

RECRUITING

MeSH Terms

Conditions

Meningococcal Infections

Interventions

4CMenB vaccine

Condition Hierarchy (Ancestors)

Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Nicole Harrison, Dr.

  Medical University Vienna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicole Harrison, Dr.

CONTACT

+43 1 40400; nicole.harrison@meduniwien.ac.at

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Nicole Harrison, Consultant for Infectious Diseases and Tropical Medicine

Model Details: prospective open-label phase II study comparing patients and healthy controls

Study Record Dates

• First Submitted: August 23, 2023
• First Posted: September 6, 2023
• Study Start: March 12, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: November 22, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)