Immunogenicity of Quadrivalent Meningococcal Conjugate Vaccine in Frequent Platelets Donors

Study Overview
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Brief Summary
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In this study, the investigators will evaluate the immunogenicity of a quadrivalent conjugate meningococcal vaccine in healthy, plateletpheresis donors.

Detailed Description
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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.

Official Title
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Immunogenicity of Quadrivalent Meningococcal Conjugate Vaccine in Frequent Platelets Donors

Conditions
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Preventive Immunization; Meningitis

Intervention / Treatment
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* Biological: Menactra


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female aged 18 years old or older Meet the standard requirements to donate platelets Have had at least one plateletpheresis in the prior 365 days (including the day of enrollment) Exclusion Criteria: Participants who donated platelets in any other medical center in the previous 365 days Severe allergic reaction to a previous meningococcal vaccine or to any component of MenACYW-D History of Guillain-Barré syndrome

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Low number plateletpheresis donations<br>Participants that have had 1-2 plateletpheresis donations in the last 365 days. Menactra will be administered as a 0.5 mL dose. | Biological: Menactra<br>* 0.5 mL dosage of Menactra will be administered by intramuscular injection in the deltoid muscle on day 0.<br>|
| Active Comparator: Medium number plateletpheresis donations<br>Participants that have had 3-19 plateletpheresis donations in the last 365 days. Menactra will be administered as a 0.5 mL dose. | Biological: Menactra<br>* 0.5 mL dosage of Menactra will be administered by intramuscular injection in the deltoid muscle on day 0.<br>|
| Active Comparator: High number plateletpheresis donations<br>Participants that have had 20-24 plateletpheresis donations in the last 365 days. Menactra will be administered as a 0.5 mL dose. | Biological: Menactra<br>* 0.5 mL dosage of Menactra will be administered by intramuscular injection in the deltoid muscle on day 0.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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. |