Immunogenicity of Quadrivalent Meningococcal Conjugate Vaccine in Frequent Platelets Donors

NCT04224311 | Unknown Phase 4 FDA Drug

• 1 other identifier: 2019P003638
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Preventive Immunization; Meningitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Seroprotection

  Months 1 and 6.

Study Arms (3)

Low number plateletpheresis donations

ACTIVE COMPARATOR

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

Medium number plateletpheresis donations

ACTIVE COMPARATOR

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

High number plateletpheresis donations

ACTIVE COMPARATOR

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

Interventions

Menactra BIOLOGICAL

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

High number plateletpheresis donations; Low number plateletpheresis donations; Medium number plateletpheresis donations

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

• Desjardins M, Cunningham P, Mitre X, Pierre D, Montesano C, Woods T, Oganezova K, Krauss JH, Von SS, Kupelian JA, Li X, Gothing JA, Kleinjan JA, Zhou G, Piantadosi S, Sherman AC, Walsh SR, Issa NC, Kaufman RM, Baden LR. Immunogenicity of quadrivalent meningococcal conjugate vaccine in frequent platelet donors. Blood. 2023 Jul 13;142(2):202-209. doi: 10.1182/blood.2022019482.

  PMID: 37172200 DERIVED

MeSH Terms

Conditions

Meningitis

Interventions

Meningococcal Vaccines

Condition Hierarchy (Ancestors)

Neuroinflammatory Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Lindsey Baden, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 8, 2020
• First Posted: January 13, 2020
• Study Start: March 12, 2020
• Primary Completion: October 1, 2023
• Study Completion: April 15, 2024
• Last Updated: November 15, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share

Locations

US (1)