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

Primary Purpose

Preventive Immunization; Meningitis

Status
Active
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Menactra
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Preventive Immunization; Meningitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Brigham and Women's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Low number plateletpheresis donations

Medium number plateletpheresis donations

High number plateletpheresis donations

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Seroprotection
The pre- and post-vaccination seroprotection, such as SBA titer greater than or equal to 1:8.

Full Information

First Posted
January 8, 2020
Last Updated
November 13, 2022
Sponsor
Brigham and Women's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04224311
Brief Title
Immunogenicity of Quadrivalent Meningococcal Conjugate Vaccine in Frequent Platelets Donors
Acronym
PLAT
Official Title
Immunogenicity of Quadrivalent Meningococcal Conjugate Vaccine in Frequent Platelets Donors
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 12, 2020 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
April 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preventive Immunization; Meningitis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
102 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low number plateletpheresis donations
Arm Type
Active Comparator
Arm Description
Participants that have had 1-2 plateletpheresis donations in the last 365 days. Menactra will be administered as a 0.5 mL dose.
Arm Title
Medium number plateletpheresis donations
Arm Type
Active Comparator
Arm Description
Participants that have had 3-19 plateletpheresis donations in the last 365 days. Menactra will be administered as a 0.5 mL dose.
Arm Title
High number plateletpheresis donations
Arm Type
Active Comparator
Arm Description
Participants that have had 20-24 plateletpheresis donations in the last 365 days. Menactra will be administered as a 0.5 mL dose.
Intervention Type
Biological
Intervention Name(s)
Menactra
Intervention Description
0.5 mL dosage of Menactra will be administered by intramuscular injection in the deltoid muscle on day 0.
Primary Outcome Measure Information:
Title
Seroresponse of vaccine
Description
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.
Time Frame
Months 1 and 6.
Secondary Outcome Measure Information:
Title
Seroprotection
Description
The pre- and post-vaccination seroprotection, such as SBA titer greater than or equal to 1:8.
Time Frame
Months 1 and 6.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lindsey Baden, MD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Deidentified data will be made available upon request to the principal investigator following the publication of the primary manuscript.

Learn more about this trial

Immunogenicity of Quadrivalent Meningococcal Conjugate Vaccine in Frequent Platelets Donors

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