Immunogenicity of Quadrivalent Meningococcal Conjugate Vaccine in Frequent Platelets Donors
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- Seroresponse of vaccine
研究概览
简要总结
In this study, the investigators will evaluate the immunogenicity of a quadrivalent conjugate meningococcal vaccine in healthy, plateletpheresis donors.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Seroresponse of vaccine
时间窗: Months 1 and 6.
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.
次要结局
- Seroprotection(Months 1 and 6.)
研究者
Lindsey R. Baden, MD
Principal Investigator
Brigham and Women's Hospital