Wormser G P, Nowakowski J, Nadelman R B, Schwartz I, McKenna D, Holmgren D, Aguero-Rosenfeld M
Div. of Infectious Diseases, Westchester County Medical Center, New York Medical College, Valhalla 10595, USA.
Infection. 1998 Jul-Aug;26(4):208-12. doi: 10.1007/BF02962365.
A multicenter, double-blinded, placebo-controlled study was done comparing a 30-microgram dose of a single protein recombinant OspA vaccine preparation with a saline placebo for efficacy in prevention of Lyme disease in humans. The OspA vaccine (30-microgram dose) or saline placebo was given intramuscularly at day 0, 1 month later, and 12 months later. Cases of possible Lyme disease were evaluated clinically and using culture, polymerase chain reaction and immunoblot assays. Safety data are being analyzed separately. 1,634 adult volunteers were enrolled at a single center in New York State. Vaccine efficacy during the first year was 40% and during the second 37%. Compared with placebo, the OspA vaccine significantly reduced the frequency of Lyme disease during the 2-year study period (P < 0.04, one-tailed Fisher's exact test). Vaccine efficacy was restricted to volunteers under 60 years old (50% vs 9%, P < 0.03, two-tailed Fisher's exact test). A recombinant OspA vaccine preparation was found to have moderate activity in preventing Lyme disease in adults under 60 years old from New York State. Reasons for vaccine failure need to be addressed and a risk benefit ratio calculated.
开展了一项多中心、双盲、安慰剂对照研究，比较30微克剂量的单一蛋白重组OspA疫苗制剂与生理盐水安慰剂预防人类莱姆病的疗效。在第0天、1个月后和12个月后肌肉注射OspA疫苗（30微克剂量）或生理盐水安慰剂。对可能的莱姆病病例进行临床评估，并使用培养、聚合酶链反应和免疫印迹分析。安全性数据正在单独分析。1634名成年志愿者在纽约州的一个中心入组。第一年的疫苗效力为40%，第二年为37%。与安慰剂相比，在2年的研究期间，OspA疫苗显著降低了莱姆病的发病率（P < 0.04，单尾Fisher精确检验）。疫苗效力仅限于60岁以下的志愿者（50%对9%，P < 0.03，双尾Fisher精确检验）。发现一种重组OspA疫苗制剂在预防纽约州60岁以下成年人的莱姆病方面具有中等活性。需要探讨疫苗失败的原因并计算风险效益比。
