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In this study, the investigators will evaluate the immunogenicity of a quadrivalent conjugate meningococcal vaccine in healthy, plateletpheresis donors.
This will be an open-label prospective vaccine response study evaluating one dose of MenACWY-D in plateletpheresis donors at the Brigham and Women's Hospital (BWH). Potential participants will be divided into three groups according to the number of plateletpheresis within 365 days of enrollment (including the day of enrollment): 1-2 sessions group (considered as the control group), 3-19 sessions group, 20-24 sessions group and randomly sampled from in allocation proportions of 0.45, 0.10, and 0.45, respectively; justification for this approach is provided in the Statistical Analysis section. MenACWY-D vaccine will be administered to each patient. Pre- and post-vaccination blood will be collected to assess immunogenicity, likely using serum bactericidal antibody (SBA) against Neisseria meningitidis for each serogroup. Immunogenicity will be primarily evaluated by seroresponse such as a fourfold increase of SBA titers between pre- and post-vaccination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low number plateletpheresis donations | Active Comparator | Participants that have had 1-2 plateletpheresis donations in the last 365 days. Menactra will be administered as a 0.5 mL dose. |
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| Medium number plateletpheresis donations | Active Comparator | Participants that have had 3-19 plateletpheresis donations in the last 365 days. Menactra will be administered as a 0.5 mL dose. |
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| High number plateletpheresis donations | Active Comparator | Participants that have had 20-24 plateletpheresis donations in the last 365 days. Menactra will be administered as a 0.5 mL dose. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Menactra | Biological | 0.5 mL dosage of Menactra will be administered by intramuscular injection in the deltoid muscle on day 0. |
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| Measure | Description | Time Frame |
|---|---|---|
| Seroresponse of vaccine | The primary outcome will be the seroresponse of MenACYW-D vaccination, such as a fourfold change of SBA titers between pre- and post-vaccination for each of the 4 antigens. | Months 1 and 6. |
| Measure | Description | Time Frame |
|---|---|---|
| Seroprotection | The pre- and post-vaccination seroprotection, such as SBA titer greater than or equal to 1:8. | Months 1 and 6. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lindsey Baden, MD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37172200 | Derived | Desjardins M, Cunningham P, Mitre X, Pierre D, Montesano C, Woods T, Oganezova K, Krauss JH, Von SS, Kupelian JA, Li X, Gothing JA, Kleinjan JA, Zhou G, Piantadosi S, Sherman AC, Walsh SR, Issa NC, Kaufman RM, Baden LR. Immunogenicity of quadrivalent meningococcal conjugate vaccine in frequent platelet donors. Blood. 2023 Jul 13;142(2):202-209. doi: 10.1182/blood.2022019482. |
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Deidentified data will be made available upon request to the principal investigator following the publication of the primary manuscript.
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| ID | Term |
|---|---|
| D008581 | Meningitis |
| ID | Term |
|---|---|
| D000090862 | Neuroinflammatory Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D022401 | Meningococcal Vaccines |
| ID | Term |
|---|---|
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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