Meningococcal B Vaccine in Patients With Asplenia
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ClinicalTrials.gov Identifier: NCT06025487 |
Recruitment Status :
Not yet recruiting
First Posted : September 6, 2023
Last Update Posted : September 6, 2023
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Splenectomy; Status | Biological: Bexsero | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 80 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | prospective open-label phase II study comparing patients and healthy controls |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Immunogenicity and Safety of a Meningococcal Serogroup B Vaccine in Adult Patients With Asplenia |
Estimated Study Start Date : | October 1, 2023 |
Estimated Primary Completion Date : | June 1, 2025 |
Estimated Study Completion Date : | June 1, 2025 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Patients
Asplenic patients receiving two doses of Bexsero (meningococcal B vaccine) with one-month interval between doses
|
Biological: Bexsero
two doses of Bexsero are applied intramuscularly with a one-month interval between doses |
Active Comparator: Healthy controls
Healthy controls receiving two doses of Bexsero (meningococcal B vaccine) with one-month interval between doses
|
Biological: Bexsero
two doses of Bexsero are applied intramuscularly with a one-month interval between doses |
- 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.
- Persistence of humoral immunity [ Time Frame: six months after second vaccination ]The persistence of antibodies six months after second vaccination as measured by hSBA
- Cellular immunogenicity - lymphocyte proliferation [ Time Frame: one month after second vaccination ]The cellular immune response as measured by lymphocyte proliferation assay
- Cellular Immunogenicity - cytokine levels [ Time Frame: one month after second vaccination ]The cellular immune response as measured by cytokine levels using Luminex
- Adverse Events [ Time Frame: four weeks after first and second vaccination ]Evaluation of safety by documenting all adverse events after vaccination
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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
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:
- 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:
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06025487
Contact: Nicole Harrison, Dr. | +43 1 40400 ext 44400 | nicole.harrison@meduniwien.ac.at |
Principal Investigator: | Nicole Harrison, Dr. | Medical University Vienna |
Responsible Party: | Nicole Harrison, Dr. Nicole Harrison, Consultant for Infectious Diseases and Tropical Medicine, Medical University of Vienna |
ClinicalTrials.gov Identifier: | NCT06025487 |
Other Study ID Numbers: |
MenB_Asplenia 2022-001451-16 ( EudraCT Number ) |
First Posted: | September 6, 2023 Key Record Dates |
Last Update Posted: | September 6, 2023 |
Last Verified: | August 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Asplenia Meningococcal disease Meningococcal B vaccine |