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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Preventive Immunization; Meningitis
• Intervention / Treatment: Biological: Menactra

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.

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Biological: Menactra; 0.5 mL dosage of Menactra will be administered by intramuscular injection in the deltoid muscle on day 0.
Active Comparator: 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.	Biological: Menactra; 0.5 mL dosage of Menactra will be administered by intramuscular injection in the deltoid muscle on day 0.
Active Comparator: 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.	Biological: Menactra; 0.5 mL dosage of Menactra will be administered by intramuscular injection in the deltoid muscle on day 0.

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Investigators: Principal Investigator: Lindsey Baden, MD, Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2020
• Primary Completion (Anticipated): October 1, 2023
• Study Completion (Anticipated): April 15, 2024

Study Registration Dates

• First Submitted: January 8, 2020
• First Submitted That Met QC Criteria: January 8, 2020
• First Posted (Actual): January 13, 2020

Study Record Updates

• Last Update Posted (Actual): November 15, 2022
• Last Update Submitted That Met QC Criteria: November 13, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Meningitis
• Other Study ID Numbers: 2019P003638

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified data will be made available upon request to the principal investigator following the publication of the primary manuscript.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No