An Open-Label, Phase III, Randomized Study of Pneumococcal Conjugate Vaccination in HIV, in Comparison to Polysaccharide Vaccine Boosting in Previously Vaccinated Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 275
- 试验地点
- 6
- 主要终点
- Positive Immune Responses in the Human Immunodeficiency Virus (HIV)-Infected Pneumococcal Conjugate Vaccine (PCV) and Pneumococcal Polysaccharide Vaccine (PPV) Arms
研究概览
简要总结
Purpose: To study the immune response of the newly licensed pneumococcal conjugate vaccine (PCV) in comparison to the pneumococcal polysaccharide vaccine (PPV) to determine if a significantly better immunologic response to boosting can be elicited in patients previously vaccinated with PPV.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Group 1
PCV, 210 patients
干预措施: pneumococcal conjugate vaccine (Biological)
Group 2
PPV, 110 patients
干预措施: pneumococcal polysaccharide vaccine (Biological)
Group 3
PCV, HIV-negative, 25 patients
干预措施: pneumococcal conjugate vaccine (Biological)
结局指标
主要结局
Positive Immune Responses in the Human Immunodeficiency Virus (HIV)-Infected Pneumococcal Conjugate Vaccine (PCV) and Pneumococcal Polysaccharide Vaccine (PPV) Arms
时间窗: Day 14, 60, and 180 after vaccination
The primary end point is greater than or equal to a 2-fold increase in the IgG level for at least 2 of the 4 serotypes on day 60, with levels greater than or equal to 1000 ng/mL.
Adverse Events (AEs) Occurring Temporally (Within 7 Days) in Association With Pneumococcal Vaccination
时间窗: Day 7 after vaccination
次要结局
- Assessment of the Importance of the Host Immune Status (CD4+ Count) on the PCV and PPV Immunologic Response.(Day 60 after vaccination)
- Assessment of CD4+ Cell Count Changes Caused by Vaccination With PCV and PPV.(Day 14, 60, and 180 after vaccination)
- Assessment of Viral Load Changes Caused by Vaccination With PCV and PPV.(Day 14, 60, and 180 after vaccination)
研究者
Brian Agan
Deputy Science Director, IDCRP
Henry M. Jackson Foundation for the Advancement of Military Medicine