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首页> 外文期刊>Vaccine >Phase I study of detoxified Escherichia coli J5 lipopolysaccharide (J5dLPS)/group B meningococcal outer membrane protein (OMP) complex vaccine in human subjects
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Phase I study of detoxified Escherichia coli J5 lipopolysaccharide (J5dLPS)/group B meningococcal outer membrane protein (OMP) complex vaccine in human subjects

机译：排毒的大肠杆菌J5脂多糖（J5dLPS）/ B组脑膜炎球菌外膜蛋白（OMP）复合疫苗的第一阶段研究

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We previously observed that a detoxified Escherichia coli O111, Re chemotype J5 lipopolysaccharide (J5dLPS)/group B meningococcal outer membrane protein (OMP) vaccine protected animals from experimental lethal sepsis when immune antibodies were given passively as treatment at the onset of fever or when vaccine was given actively as prophylaxis. To test the safety and immunogenicity of this vaccine, we administered doses of 5, 10 and 25 mug (based on dLPS) of vaccine at days 0, 28 and 56 to 24 human subjects (8 per group). Temperatures of 100.3, 99.5 and 99.4 degreesF occurred in three subjects. At 24 h, pain at the injection site was moderate in 38%, mild in 44% and not present in 18%, while at 48 h, it was 1, 25 and 73%, respectively. No alterations in baseline renal, hepatic or hematologic functions occurred. There were two to three times mean-fold increases in anti-J5dLPS IgG (range: 1.9-5.1) and IgM (range: 1.2-9.2) levels in subjects receiving the 10 and 25 mug doses. At 12-month follow-up, three of the original responders had continued elevation of antibody levels. A 25 mug booster dose of vaccine did not increase antibody levels among those responders and did not elicit antibodies among three subjects with no previous antibody response. The plasma from the six volunteers inhibited LPS-induced cytokine generation in human whole blood ex vivo. We conclude that this J5dLPS/OMP vaccine was safe and well-tolerated with transient, local pain at the injection site. Vaccine formulations with different adjuvants are currently under investigation.
机译：我们先前观察到，当发烧或疫苗接种时被动给予免疫抗体时，排毒的大肠杆菌O111，Re化学型J5脂多糖（J5dLPS）/ B组脑膜炎球菌外膜蛋白（OMP）疫苗可保护动物免受实验性败血症的伤害。积极给予预防。为了测试这种疫苗的安全性和免疫原性，我们在第0、28和56天的人类受试者（每组8位）接种了5、10和25杯（基于dLPS）疫苗。三名受试者的温度分别为100.3、99.5和99.4华氏度。在24小时时，注射部位的疼痛为中度，分别为38％，44％和18％，而48小时时分别为1％，25％和73％。基线肾，肝或血液功能未发生改变。在接受10杯和25杯疫苗剂量的受试者中，抗J5dLPS IgG（范围：1.9-5.1）和IgM（范围：1.2-9.2）的平均水平增加了2到3倍。在12个月的随访中，三名原始应答者的抗体水平持续升高。 25杯加强剂量的疫苗不会增加那些应答者中的抗体水平，也不会在没有先前抗体应答的三名受试者中引发抗体。六名志愿者的血浆离体抑制了人全血中LPS诱导的细胞因子的生成。我们得出的结论是，这种J5dLPS / OMP疫苗是安全的，并且在注射部位具有短暂的局部疼痛耐受性良好。目前正在研究具有不同佐剂的疫苗制剂。

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