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首页> 外文期刊>Infection and immunity >Safety and immunogenicity in human volunteers of a chloroform-methanol residue vaccine for Q fever.
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Safety and immunogenicity in human volunteers of a chloroform-methanol residue vaccine for Q fever.

机译：氯仿-甲醇残留疫苗用于Q发热的人类志愿者的安全性和免疫原性。

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Current Q fever vaccines, consisting of Formalin-inactivated phase I whole Coxiella burnetii, are highly efficacious in preventing disease in high-risk settings but are associated with a risk of unacceptable local reactions in previously immune individuals and require cumbersome preliminary immunologic evaluation of potential vaccinees. A vaccine prepared from the residue of chloroform-methanol extraction of phase I Henzerling strain C. burnetii (CMR) has been shown to be less reactogenic but still immunogenic and protective in small animals and sheep. In a placebo-controlled trial, we immunized 35 healthy adults unscreened for markers of prior C. burnetii immunity with a single subcutaneous CMR dose of 30, 60, 120, or 240 micrograms. None of those receiving the 30- or 60-micrograms CMR dose and none of the placebo recipients experienced any adverse effects. Five of 15 120-micrograms dose CMR recipients complained of transient discomfort in the inoculated arm; erythema or induration of > or = 100 mm2 was noted in three and four, respectively, and two had malaise and low-grade fever (< 101 degrees F, orally). No 240-micrograms dose vaccinee reported limb discomfort, but 7 of 10 had erythema and/or induration of > or = 100 mm2 (P < 0.001 versus placebo). Two reported malaise, and one had low-grade fever. All adverse effects were self-limited. Serum immunoglobulin M responses were optimally detected with CMR antigen and occurred in 50, 60, 73, and 90% of recipients of the 30-, 60-, 120-, and 240-micrograms doses, respectively; results with phase I whole-cell antigen were similar. Serum immunoglobulin G responses were best detected with phase II antigen and were seen in 20, 20, and 40% of those receiving the 60-, 120-, and 240-micrograms doses, respectively. Peripheral blood T-cell proliferative responses to C. burnetii recall antigens were transient and of low magnitude but were seen with CMR antigen in 33% of 120-micrograms dose recipients and 40% of 240-micrograms dose recipients. Data from this study and those from comparative-efficacy trials in primates should provide the basis for field trials of the CMR vaccine.
机译：目前的Q发烧疫苗由福尔马林灭活的I期整个伯氏柯氏杆菌组成，在高风险环境中预防疾病方面非常有效，但与先前免疫个体发生局部反应的风险有关，需要对潜在疫苗进行繁琐的初步免疫学评估。已经证明，由I期亨舍尔氏菌株C. burnetii（CMR）的氯仿-甲醇萃取残留物制备的疫苗对小动物和绵羊的反应原性较低，但仍具有免疫原性和保护性。在安慰剂对照试验中，我们以30、60、120或240微克的单次皮下CMR剂量免疫了35名未筛选过伯氏梭菌免疫力标记的健康成年人。接受30或60毫克CMR剂量的患者和安慰剂接受者均未出现任何不良反应。 15 120毫克剂量的CMR接受者中有5位抱怨接种的手臂暂时不适。红斑或硬结> 100 mm2的分别出现在三个和四个中，两个出现不适和低烧（口服<101华氏度）。没有240毫克剂量的被疫苗接种者报告肢体不适，但十分之七的患者出现红斑和/或硬结≥100 mm2（与安慰剂相比，P <0.001）。两名报告不适，一名发低烧。所有不良反应都是自限性的。用CMR抗原可以最佳地检测血清免疫球蛋白M反应，分别在30、60、120和240毫克剂量的50、60、73和90％的接受者中发生。 I期全细胞抗原的结果相似。血清免疫球蛋白G反应最好用II期抗原检测到，分别在分别接受60、120和240毫克剂量的患者中有20％，20％和40％可见。对伯氏梭菌召回抗原的外周血T细胞增殖反应是短暂的且幅度较小，但在33％的120微克剂量接受者和40％的240微克剂量接受者中观察到CMR抗原。这项研究的数据以及灵长类动物的比较功效试验的数据应为CMR疫苗的现场试验提供基础。

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