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| ID | Type | Description | Link |
|---|---|---|---|
| I72P1 |
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| Name | Class |
|---|---|
| Novartis Vaccines | INDUSTRY |
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The study involves the measurement of immune response to vaccination with three doses of a meningococcal B vaccine and a single dose of a meningococcal ACYW conjugate vaccine in healthy adults (Laboratory workers). The study will be completed at the Manchester Medical Microbiology Partnership in the UK and will enrol staff who may be at potential occupational exposure to meningococci. Blood samples will be taken before and after each vaccination and used to determine if the vaccines induce protective responses.
Laboratory staff at the Manchester Medical Microbiology Partnership may be at potential occupational exposure to meningococci. No licensed vaccine is available against serogroup B meningococci and the available plain polysaccharide serogroup ACYW vaccine is poorly immunogenic. Novartis Vaccines have developed an investigational serogroup B vaccine and a conjugated ACYW vaccine. This study will investigate these vaccines ability to induce a protective response in laboratory staff from the Manchester Medical Microbiology Partnership. Three doses of the meningococcal B vaccine will be administered at 0, 2 and 6 months and a single dose will be administered at 0 months. Blood samples will be taken before and after each vaccination and functional antibodies determined.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| meningococcal B vaccine & meningococcal ACYW conjugate vaccine | Drug | Meningococcal B vaccine will be administered at 0, 2 and 6 months and a single dose of meningococcal ACYW vaccine will be administered at 0 months, concomitantly with the first dose of the meningococcal B vaccine. |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects attaining putative protective antibody concentrations against meningococci in the serum bactericidal antibody assay | one month following the last vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ray Borrow, PhD | Public Health England | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Manchester Medical Microbiology Partnership | Manchester | M13 9WZ | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26025807 | Background | Findlow J, Bai X, Findlow H, Newton E, Kaczmarski E, Miller E, Borrow R. Safety and immunogenicity of a four-component meningococcal group B vaccine (4CMenB) and a quadrivalent meningococcal group ACWY conjugate vaccine administered concomitantly in healthy laboratory workers. Vaccine. 2015 Jun 26;33(29):3322-30. doi: 10.1016/j.vaccine.2015.05.027. Epub 2015 May 27. | |
| 40043411 |
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| Ramirez-Bencomo F, Thistlethwaite A, Viviani V, Bartolini E, Pizza M, Biolchi A, Muzzi A, Delany I, Awanye AM, Chang CM, Borrow R, Derrick JP. Identification of immunogenic outer membrane vesicle vaccine antigen components using a meningococcal protein microarray. Vaccine. 2025 Apr 19;53:126953. doi: 10.1016/j.vaccine.2025.126953. Epub 2025 Mar 4. |
| ID | Term |
|---|---|
| D008585 | Meningitis, Meningococcal |
| D008581 | Meningitis |
| ID | Term |
|---|---|
| D016920 | Meningitis, Bacterial |
| D020806 | Central Nervous System Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D008589 | Meningococcal Infections |
| D016870 | Neisseriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D002494 | Central Nervous System Infections |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000090862 | Neuroinflammatory Diseases |
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| ID | Term |
|---|---|
| C570015 | 4CMenB vaccine |
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