Investigating for Immunological Correlates of Protection Against Invasive Group B Streptococcus Disease in Infants Less Than 90 Days of Age.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 17,842
- 试验地点
- 1
- 主要终点
- Primary Objective
研究概览
简要总结
Streptococcus agalactiae or Group B Streptococcus (GBS) is a leading cause of neonatal sepsis in developed and developing countries.
The study aims to bolster the evidence base of establishing a sero-correlate of protection against invasive GBS disease in infants.
These sero-correlates of protection will be used to study the effectiveness of GBS vaccine against invasive disease.
详细描述
Observational Case-Control Study
- A cohort of 15,000 mother-infant dyads will be enrolled at Chris Hani Baragwanath Academic Hospital (n=10,000) and Rahima Moosa Mother and Child Hospital(n=5,000) over an 18-24-month period, anticipated to start in the first quarter of 2019.
- Enrolment into the cohort study will occur at antenatal clinic, during the early stages either of labour or immediately post-delivery.
- In parallel, enrolment of GBS cases will occur at the time of diagnosis of invasive GBS disease. These "retrospective cases" will be enrolled at multiple facilities across South Africa.
- Infants will be followed up until 89 days of age to identify cases of suspected sepsis and hospitalizations.
Determine the infant GBS serotype Ia and III specific capsular serum IgG antibody level associated with 80% reduced odds of invasive GBS disease between 0-89 days of age for the combined "cohort" and "retrospectively enrolled" cases.
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 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Pregnant women attending for antenatal care at one of the participating antenatal-clinics and/or delivering at CHBAH or RMMCH.
- •Subjects aged ≥18 years.
- •Able to understand and comply with planned study procedures.
- •Provides written informed consent.
排除标准
- •Refusal to consent to study participation.
- •Receipt of any blood products in the past 4 weeks or anticipated during labour.
结局指标
主要结局
Primary Objective
时间窗: 1 - 1.5 years
Determine the infant GBS serotype Ia and III specific capsular serum IgG antibody level associated with 80% reduced odds of invasive GBS disease between 0-89 days of age for the combined "cohort" and "retrospectively enrolled" cases. Anti-CPS IgG concentrations were determined with the use of a quantitative direct immunoassay (Luminex) that measured levels of antibodies binding to CPS serotypes Ia, Ib, and II through V.
次要结局
未报告次要终点
研究者
Farzanah Laher
Doctor
University of Witwatersrand, South Africa