Sigal L H, Zahradnik J M, Lavin P, Patella S J, Bryant G, Haselby R, Hilton E, Kunkel M, Adler-Klein D, Doherty T, Evans J, Molloy P J, Seidner A L, Sabetta J R, Simon H J, Klempner M S, Mays J, Marks D, Malawista S E
Department of Medicine, University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School, New Brunswick 08903-0019, USA.
N Engl J Med. 1998 Jul 23;339(4):216-22. doi: 10.1056/NEJM199807233390402.
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.
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.
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.
In this study, OspA vaccine was safe and effective in the prevention of Lyme disease.
莱姆病是一种多系统炎症性疾病，由蜱传播的螺旋体伯氏疏螺旋体感染引起，是美国最常见的媒介传播感染。我们评估了一种不含佐剂的由外表面蛋白A（OspA）组成的重组疫苗对莱姆病高危人群的疗效。
在这项双盲试验中，在美国莱姆病流行地区的14个地点招募了10305名18岁及以上的受试者；受试者被随机分配接受安慰剂（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，7515名受试者在12个月时还接受了加强剂量。在莱姆病传播风险较高的两个季节观察受试者。主要终点是新的临床和血清学确诊的莱姆病病例数。
在研究的第一年，疫苗对整个人群的疗效为68%，在接受第三次注射的3745名受试者中，第二年的疗效为92%。疫苗耐受性良好。疫苗组轻度、自限性局部和全身反应的发生率较高，但仅在接种疫苗后的七天内。疫苗接种者中关节炎或神经系统事件的发生率没有显著增加。
在本研究中，OspA疫苗在预防莱姆病方面安全有效。
