TRIAL OF THE SAFETY /IMMUNOGENICITY OF PNEUMOCOCCAL CONJUGATE VACCINE

肺炎球菌结合疫苗的安全性/免疫原性试验

• 批准号: 6120800
• 负责人: Kenneth McIntosh
• 金额: $ 3.04万
• 依托单位: BOSTON CHILDREN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6120800
• 关键词: AIDS therapy; HIV infections; Streptococcus pneumoniae vaccine; bacterial disease; child (0-11); clinical research; clinical trial phase I; drug screening /evaluation; genetic strain; human subject; immunoconjugates; opportunistic infections; pediatric AIDS; secondary infection; vaccine development

This is a double-blind, phase I/II, placebo-controlled ACTG study that will evaluate the safety and immunogenicity of a seven valent pneumococcal conjugate vaccine. Streptococcus pneumoniae causes serious infections in humans, such as pneumonia, meningitis, sepsis, and arthritis. This organism also causes more common, but less severe infections, such as otitis media and sinusitis. Adults with human immunodeficiency virus infection are recognized to be at high risk for severe pneumococcal infection. Children with HIV infection have a high incidence of bacterial pneumonia, otitis media and sinusitis, a large fraction of which are likely to be caused by pneumococcus. It has recently been recognized that children with HIV infection are at increased risk for invasive pneumococcal infection, particularly bacteremia. This trial proposes a polyvalent conjugate vaccine directed against those pneumococcus serotypes that are responsible for up to 90% of invasive disease in these children.

这是一项双盲、I/II 期、安慰剂对照 ACTG 研究 将评估七价疫苗的安全性和免疫原性 肺炎球菌结合疫苗。肺炎链球菌引起严重 人类感染，例如肺炎、脑膜炎、败血症和 关节炎。这种生物体也会导致更常见但不太严重的 感染，例如中耳炎和鼻窦炎。成人与人类 免疫缺陷病毒感染被认为是高风险 用于严重肺炎球菌感染。感染艾滋病毒的儿童有 细菌性肺炎、中耳炎、鼻窦炎发病率高 其中很大一部分可能是由肺炎球菌引起的。它有 最近人们认识到感染艾滋病毒的儿童处于 侵袭性肺炎球菌感染的风险增加，特别是 菌血症。该试验提出了一种多价结合疫苗 针对高达 90% 的肺炎球菌血清型 这些儿童的侵袭性疾病。