Evaluation of the Immunogenicity of Meningococcal B (4CMenB) and Meningococcal ACWY (MenACWY Conjugate) Vaccination in a Population With HIV at 18 and 30 Months After Two Doses of Vaccine
试验速览
- 阶段
- 不适用
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Serum bacteridical Assay responses against relevant MenB strains at 18 and 30 months post two doses Bexsero (administered concomitantly with Menveo)
研究概览
简要总结
The need for and timing of booster doses of meningococcal vaccines in People Living with HIV (PLWHIV) is currently unknown. As such it is impossible for clinicians to recommend booster doses or to know if and when these might be necessary.We propose to follow up a group of participants from the Propositive study who received two doses of both MenB (Bexsero) and MenACWY (Menveo). This was a group of PLWHIV between the ages 18-45 years. We propose following up these participants at 18 and 30 months post completion of two doses of vaccine and investigating their immunological response.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 47 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Received vaccination with Bexsero and Menveo during Propositive study
- •Able to sign fully informed consent
- •Able to comply with study requirements
排除标准
- •Unwilling or unable to comply with study requirements
结局指标
主要结局
Serum bacteridical Assay responses against relevant MenB strains at 18 and 30 months post two doses Bexsero (administered concomitantly with Menveo)
时间窗: The 18 month blood test is taken 548 days (+/-60 days) from completion of vaccination during the Propositive study and the 30 month blood test is taken 912 days (+/- 60 days) after completion of vaccination
1. Geometric Mean Titres against relevant MenB strains at 18 and 30 months post two doses of Bexsero 2. The proportion of subjects with at least 4 fold increase in hSBA against relevant MenB strains from baseline compared to 18 month and 30 months post two doses of Bexsero 3. The proportion of subjects with "protective" hSBA titres \>4 against relevant MenB strains at 18 months and 30 months post two doses of Bexsero
次要结局
- Serum bactericidal Assay responses against relevant MenACWY strains at 18 and 30 months post two doses Menveo (administered concomitantly with Bexsero)(The 18 month blood test is taken 548 days (+/-60 days) from completion of vaccination during the Propositive study and the 30 month blood test is taken 912 days (+/- 60 days) after completion of vaccination)