NCT04224311

Immunogenicity of Quadrivalent Meningococcal Conjugate Vaccine in Frequent Platelets Donors

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• Preventive Immunization; Meningitis

Interventions

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

Timeline

• Start date: 2020-03-12
• Primary completion: 2023-10-01
• Completion: 2024-04-15
• First posted: 2020-01-13
• Last updated: 2022-11-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study