A Pilot Study Assessing the Efficacy of Pneumococcal Vaccine in HIV Patients: Delayed Versus Immediate Immunization
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 79
- 试验地点
- 15
- 主要终点
- Number of serotypes to which a response is found
研究概览
简要总结
The purpose of this study is to determine whether people who are HIV-positive respond better to a vaccine for pneumonia-related disease when they are immunized immediately, or when immunization is delayed until the immune system has improved to a certain level. The study will also compare the effectiveness of polysaccharide and heptavalent vaccines.
详细描述
A multicentre, randomized controlled trial using a two factorial design. Eighty patients will be randomly assigned to receive either Pneumovax (or Pneumo23 according to standard use at site) or heptavalent pneumococcal conjugate vaccine (Prevnar) prior to reconstitution of the immune system or will have immunization delayed until their CD4 count is greater than 200 cells/mm3 after the introduction of antiretroviral therapy. Randomization will be stratified by study centre. Variable block sizes will be used to try to prevent study personnel from guessing the next allocation. Random allocation lists will be generated by computer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV-positive
- •Between 18 and 65 years of age
- •Have a CD4 cell count below 200 cells/mm3
- •Willing to begin/change antiretroviral therapy
- •Willing and able to provide informed consent
排除标准
- •Pregnant or breastfeeding
- •Have had previous pneumococcal vaccination
- •Have had occurrence of pneumococcal infection (brain, blood or lung infections) in past 5 years
- •Have hypersensitivity to components of either vaccine
- •Have acute feverish illness at the time of vaccination
- •Have had splenectomy (removal of the spleen)
- •Have received treatment with IVIG within the last 6 months
结局指标
主要结局
Number of serotypes to which a response is found
A response is defined as a doubling in antibody titer at 1 month compared to baseline.
次要结局
- Adverse events
- Antibody response at 6 months and one year
- Changes in viral load 3 months post immunization
- Overall incidence of invasive pneumococcal disease
- Incidence of invasive pneumococcal disease between vaccines