Immunogenicity of Quadrivalent Meningococcal Conjugate Vaccine in Frequent Platelets Donors (PLAT)

Mass General Brigham

Status and phase: Active, not recruiting; Phase 4

Conditions: Preventive Immunization; Meningitis

Treatments: Biological: Menactra

Study type: Interventional

Funder types: Other

Identifiers

NCT04224311

2019P003638

Details and patient eligibility

About

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

Full description

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.

Enrollment: 102 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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102 participants in 3 patient groups

Low number plateletpheresis donations

Active Comparator group

Description:

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

Treatment:

Biological: Menactra

Medium number plateletpheresis donations

Active Comparator group

Description:

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

Treatment:

Biological: Menactra

High number plateletpheresis donations

Active Comparator group

Description:

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

Treatment:

Biological: Menactra