Badawi Alaa, Shering Maria, Rahman Shusmita, Lindsay L Robbin
Public Health Risk Sciences Division, National Microbiology Laboratory, Public Health Agency of Canada, Toronto, ON.
Can J Public Health. 2017 Apr 20;108(1):e62-e70. doi: 10.17269/cjph.108.5728.
Lyme borreliosis (LB) is the most prevalent arthropod-borne infectious disease in North America. Currently, no vaccine is available to prevent LB in humans, although monovalent and multivalent vaccines have been developed in the past.
The aim of the current study is to conduct a systematic review and meta-analysis to evaluate and compare the findings from these two classes of vaccines for their reactogenicity, immunogenicity and efficacy, in the hope this may assist in the development of future vaccines.
A search strategy was developed for online databases (PubMed, Ovid MEDLINE, and Embase). Search terms used were "vaccine/vaccination", "Lyme disease/Borreliosis", "clinical trial(s)" and "efficacy". Only seven clinical trials were included to compare the results of the monovalent vaccines to those of the multivalent one. Meta-analyses were conducted to evaluate the reactogenicity and immunogenicity of the two vaccine classes. Odds ratio (OR) for LB (and 95% confidence intervals; 95% CI) were calculated for the efficacy of the monovalent vaccine from three different clinical trials at different dose schedules.
Incidence of redness (local adverse effect) and fever (systemic side effect) were, respectively, 6.8- and 2.9-fold significantly lower (p < 0.05) in individuals who received multivalent vaccines compared to those receiving the monovalent one. Incidences of all other local and systemic adverse effects were non-significantly lower in the multivalent vaccine compared to the monovalent vaccines. Seroprotection was comparable among individuals who received the two vaccine classes at the 30 μg dose level. Efficacy in the prevention of LB was only evaluated for the monovalent vaccines. OR of LB ranged from 0.49 (95% CI: 0.14-0.70; p < 0.005, vs. placebo) to 0.31 (95% CI: 0.26-0.63; p < 0.005) for the initial and final doses respectively, with an overall OR of 0.4 (95% CI: 0.26-0.63, p < 0.001).
The current study further validates that the monovalent and multivalent LB vaccines result in mild local side effects and self-limiting systemic adverse effects, with the multivalent vaccine slightly more tolerable than the monovalent one. Both vaccine classes were similarly highly immunogenic. A new vaccine with high safety standards, better efficacy, low cost, and public acceptance is yet to be developed. Meanwhile, personal protection limiting exposure to ticks is recommended.
莱姆病（LB）是北美最常见的节肢动物传播的传染病。目前，尚无用于预防人类莱姆病的疫苗，尽管过去已经研发出单价和多价疫苗。
本研究的目的是进行系统评价和荟萃分析，以评估和比较这两类疫苗在反应原性、免疫原性和疗效方面的研究结果，希望这有助于未来疫苗的研发。
制定了针对在线数据库（PubMed、Ovid MEDLINE和Embase）的检索策略。使用的检索词为“疫苗/接种”、“莱姆病/疏螺旋体病”、“临床试验”和“疗效”。仅纳入了7项临床试验来比较单价疫苗和多价疫苗的结果。进行荟萃分析以评估这两类疫苗的反应原性和免疫原性。计算了来自三项不同剂量方案的不同临床试验中单价疫苗预防莱姆病的疗效的比值比（OR）及95%置信区间（95%CI）。
与接受单价疫苗的个体相比，接受多价疫苗的个体出现发红（局部不良反应）和发热（全身副作用）的发生率分别显著降低6.8倍和2.9倍（p<0.05）。与单价疫苗相比，多价疫苗的所有其他局部和全身不良反应的发生率降低但无统计学意义。在30μg剂量水平下，接受这两类疫苗的个体的血清保护作用相当。仅对单价疫苗进行了预防莱姆病的疗效评估。单价疫苗预防莱姆病的OR值，初始剂量为0.49（95%CI：0.14-0.70；p<0.005，与安慰剂相比），最终剂量为0.31（95%CI：0.26-0.63；p<0.005），总体OR为该0.4（95%CI：0.26-0.63，p<0.001）。
本研究进一步证实，单价和多价莱姆病疫苗会导致轻微的局部副作用和自限性全身不良反应，多价疫苗比单价疫苗的耐受性略好。两类疫苗的免疫原性都同样高。仍有待研发一种具有高安全标准、更好疗效、低成本且公众可接受的新型疫苗。同时，建议采取个人防护措施，减少蜱虫叮咬。
