论文部分内容阅读
背景:基于保守蛋白抗原的肺炎球菌疫苗具有提供扩大的抵抗肺炎链球菌的保护作用的潜力。目标:本研究探讨了三种剂量的成人用肺炎球菌单一抗原蛋白疫苗的安全性和免疫原性。该疫苗由氢氧化铝佐剂和重组衍生的、高解毒的、基因突变的肺炎链球菌溶血素蛋白PlyD1配制而成。方法:在Ⅰ期临床试验中,采用随机、安慰剂对照、观察者客观的剂量递增的方法来研究登记的试验对象(18~50岁)。在初步安全性研究中,参与者都接受了单次剂量的10μg PlyD1注射,并且观察24 h。检查试验安全性数据后,参与者随机分为两
Background: Pneumococcal vaccines based on the conserved protein antigens have the potential to provide expanded protection against S. pneumoniae. Objectives: This study explored the safety and immunogenicity of three doses of the pneumococcal single antigen protein vaccine for adults. The vaccine is formulated with aluminum hydroxide adjuvant and recombinantly derived, highly detoxified, genetically mutated pneumolysin protein PlyD1. METHODS: Subjects enrolled (18-50 years) were studied in a Phase I clinical trial using randomized, placebo-controlled, observational objective dose escalation. In the initial safety study, participants received a single dose of 10 μg PlyD1 injection and were observed for 24 h. After examining the experimental safety data, the participants were randomly divided into two