Immunogenicity of Quadrivalent Meningococcal Conjugate Vaccine in Frequent Platelets Donors

Preventive Immunization; Meningitis Clinical Trial

— PLAT  

Official title:

Immunogenicity of Quadrivalent Meningococcal Conjugate Vaccine in Frequent Platelets Donors

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04224311
• Other study ID #: 2019P003638
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: March 12, 2020
• Est. completion date: April 15, 2024

Study information

• Verified date: November 2022
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 102
• Est. completion date: April 15, 2024
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Meningitis
• Preventive Immunization; Meningitis

Intervention

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

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Seroprotection	The pre- and post-vaccination seroprotection, such as SBA titer greater than or equal to 1:8.	Months 1 and 6.