A Phase II Open-Label, Multi-Center Study of a Group B Streptococcus Vaccine in HIV Positive and HIV Negative Pregnant Women
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 270
- 试验地点
- 3
- 主要终点
- Geometric Mean Concentrations (GMCs) of Antibodies in Maternal Subjects and Infants at Delivery/Birth
研究概览
简要总结
The study compared the magnitude of the antibody response and safety of a GBS Trivalent Vaccine in HIV positive and HIV negative pregnant women and their offspring. In addition the study investigated the maternal to fetal transfer of antibodies induced by the investigational vaccine.
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 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women 18-40 years of age between 24-35 weeks gestation
- •Women who were HIVneg or HIVpos with WHO stage I or II disease and with CD4+ counts > 50 cells/µL
排除标准
- •Women who had CD4+ count ≤ 50 cells/µL
- •Women who were HIVpos with WHO stage III or IV disease, history of severe allergic reactions after previous vaccinations
结局指标
主要结局
Geometric Mean Concentrations (GMCs) of Antibodies in Maternal Subjects and Infants at Delivery/Birth
时间窗: Day of delivery/birth
GMCs of Group B Streptococcus (GBS)-specific Abs against serotypes Ia, Ib and III in mothers and in infants at delivery/birth are presented.
Geometric Mean Antibody Transfer Ratio Between Infant Antibody Level (μg/mL) and Maternal Antibody Level (μg/mL), for GBS Serotypes Ia, Ib and III at Delivery/Birth.
时间窗: Day of delivery/birth
The Geometric mean transfer ratio of GBS-specific Ab against serotypes Ia, Ib and III at delivery is calculated as the geometric mean of the pairwise ratios between the antibody concentrations from infant at birth and to maternal serum concentration at delivery.
次要结局
- Vaccine Induced Maternal Serotype Specific GBS Antibody Levels for GBS Serotypes Ia, Ib and III at Day 1, 15, 31 and at Delivery(Day 1, 15, 31 and at Delivery)
- Percentages of Maternal Subjects With The Enzyme-linked Immunosorbent Assay (ELISA) Antibody Levels for GBS Serotypes Ia, Ib and III Above a Specific Threshold at Delivery(Day of Delivery)
- Percentages of Subjects With Solicited Local Adverse Events (AEs)(From 6 Hours to Day 7 After Each Vaccination, for up to 24 weeks)
- Percentages of Subjects With Solicited Systemic AEs(From 6 Hours to Day 7 After Each Vaccination, for up to 24 weeks)
- Percentages of Subjects Who Experienced Unsolicited Adverse Events(Day 1 to Study Termination, for up to 24 weeks)
- Percentages of Infants Who Experienced Unsolicited Adverse Events(Birth to Study Termination, for up to 24 weeks)