Immunogenicity of Quadrivalent Meningococcal Conjugate Vaccine in Frequent Platelets Donors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-12

Study Completion Date

2024-04-15

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.

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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.

Conditions

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Preventive Immunization; Meningitis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Low number plateletpheresis donations

Participants that have had 1-2 plateletpheresis donations in the last 365 days. Menactra will be administered as a 0.5 mL dose.

Group Type ACTIVE_COMPARATOR

Menactra

Intervention Type BIOLOGICAL

0.5 mL dosage of Menactra will be administered by intramuscular injection in the deltoid muscle on day 0.

Medium number plateletpheresis donations

Participants that have had 3-19 plateletpheresis donations in the last 365 days. Menactra will be administered as a 0.5 mL dose.

Group Type ACTIVE_COMPARATOR

Menactra

Intervention Type BIOLOGICAL

0.5 mL dosage of Menactra will be administered by intramuscular injection in the deltoid muscle on day 0.

High number plateletpheresis donations

Participants that have had 20-24 plateletpheresis donations in the last 365 days. Menactra will be administered as a 0.5 mL dose.

Group Type ACTIVE_COMPARATOR

Menactra

Intervention Type BIOLOGICAL

0.5 mL dosage of Menactra will be administered by intramuscular injection in the deltoid muscle on day 0.

Interventions

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Menactra

0.5 mL dosage of Menactra will be administered by intramuscular injection in the deltoid muscle on day 0.

Intervention Type BIOLOGICAL

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes