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首页> 外文期刊>The New England journal of medicine >A vaccine consisting of recombinant Borrelia burgdorferi outer-surface protein A to prevent Lyme disease. Recombinant Outer-Surface Protein A Lyme Disease Vaccine Study Consortium (see comments) (published erratum appears in N Engl J Med 1998 Aug 20;
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A vaccine consisting of recombinant Borrelia burgdorferi outer-surface protein A to prevent Lyme disease. Recombinant Outer-Surface Protein A Lyme Disease Vaccine Study Consortium (see comments) (published erratum appears in N Engl J Med 1998 Aug 20;

机译：一种由重组伯氏疏螺旋体外表面蛋白A预防莱姆病的疫苗。重组外表面蛋白A莱姆病疫苗研究联合会（请参阅注释）（勘误表发表于1998年8月20日的N Engl J Med;

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BACKGROUND: Lyme disease is a multisystem inflammatory disease caused by infection with the tick-borne spirochete Borrelia burgdorferi and is the most common vector-borne infection in the United States. We assessed the efficacy of a recombinant vaccine consisting of outer-surface protein A (OspA) without adjuvant in subjects at risk for Lyme disease. METHODS: For this double-blind trial, 10,305 subjects 18 years of age or older were recruited at 14 sites in areas of the United States where Lyme disease was endemic; the subjects were randomly assigned to receive either placebo (5149 subjects) or 30 microg of OspA vaccine (5156 subjects). The first two injections were administered 1 month apart, and 7515 subjects also received a booster dose at 12 months. The subjects were observed for two seasons during which the risk of transmission of Lyme disease was high. The primary end point was the number of new clinically and serologically confirmed cases of Lyme disease. RESULTS: The efficacy of the vaccine was 68 percent in the first year of the study in the entire population and 92 percent in the second year among the 3745 subjects who received the third injection. The vaccine was well tolerated. There was a higher incidence of mild, self-limited local and systemic reactions in the vaccine group, but only during the seven days after vaccination. There was no significant increase in the frequency of arthritis or neurologic events in vaccine recipients. CONCLUSIONS: In this study, OspA vaccine was safe and effective in the prevention of Lyme disease.
机译：背景：莱姆病是由the传播的螺旋体伯氏疏螺旋体感染引起的多系统炎性疾病，是美国最常见的媒介传播感染。我们评估了由不含佐剂的外表面蛋白A（OspA）组成的重组疫苗在有莱姆病风险的受试者中的功效。方法：在该双盲试验中，在美国莱姆病流行地区的14个地点招募了10,305名18岁以上的受试者。随机分配受试者接受安慰剂（5149名受试者）或30微克OspA疫苗（5156名受试者）。前两次注射间隔1个月进行，并且7515名受试者在12个月时也接受了加强剂量。观察对象经历了两个季节，在此两个季节期间，莱姆病传播的风险很高。主要终点是新的临床和血清学确诊的莱姆病病例数。结果：该疫苗在研究的第一年在整个人群中的功效为68％，而在接受第三次注射的3745名受试者中，第二年的有效性为92％。疫苗耐受良好。疫苗组中轻度，自限性局部和全身反应的发生率较高，但仅在接种后的七天内。疫苗接种者中关节炎或神经系统事件的发生率没有显着增加。结论：在本研究中，OspA疫苗在预防莱姆病方面是安全有效的。

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