VANGUARD®crLyme的现场安全性研究：一种预防犬类莱姆病的疫苗。
Field safety study of VANGUARD®crLyme: A vaccine for the prevention of Lyme disease in dogs.
作者信息
Marconi Richard T, Honsberger Nicole, Teresa Winkler M, Sobell Nikki, King Vickie L, Wappel Sharon, Hoevers Jacquelien, Xu Zach, Millership Jason
机构信息
Department of Microbiology and Immunology, Virginia Commonwealth University Medical Center, Richmond, VA 23298-0678, United States.
Zoetis Inc., 333 Portage Road, Kalamazoo, MI 49007-4931, United States.
出版信息
Vaccine X. 2020 Oct 22;6:100080. doi: 10.1016/j.jvacx.2020.100080. eCollection 2020 Dec 11.
Abstract
Here we report the results of a large-scale pre-license safety study in which two serials of VANGUARD®crLyme, a vaccine for canine Lyme disease, were tested in its target population (dogs) under the conditions of its intended use. Six-hundred and twenty dogs, from three distinct geographic regions of the United States were enrolled in this study with each receiving two doses of vaccine by subcutaneous injection 3 to 4 weeks apart. Approximately one-third of the dogs were of minimum age (≤8 weeks of age) to meet regulatory requirements. Safety was evaluated by observation of local and systemic reactions for at least 10 days after each vaccination. Abnormal health events (AHEs) occurred at low frequencies and no serious AHEs were observed. The results demonstrated that VANGUARD®crLyme is safe for use in healthy dogs 8 weeks of age or older.
摘要
在此，我们报告一项大规模的上市前安全性研究结果。在该研究中，犬用莱姆病疫苗VANGUARD®crLyme的两个批次在预期使用条件下于其目标群体（犬类）中进行了测试。来自美国三个不同地理区域的620只犬参与了本研究，每只犬通过皮下注射接受两剂疫苗，间隔3至4周。约三分之一的犬为符合监管要求的最小年龄（≤8周龄）。每次接种疫苗后至少观察10天，通过观察局部和全身反应来评估安全性。异常健康事件（AHE）发生频率较低，未观察到严重的AHE。结果表明，VANGUARD®crLyme对于8周龄及以上的健康犬使用是安全的。
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本文引用的文献
1
Development and optimization of OspC chimeritope vaccinogens for Lyme disease.开发和优化莱姆病 OspC 嵌合表位疫苗原。
Vaccine. 2020 Feb 18;38(8):1915-1924. doi: 10.1016/j.vaccine.2020.01.027. Epub 2020 Jan 17.
2
Characterization of recombinant OspA in two different Borrelia vaccines with respect to immunological response and its relationship to functional parameters.两种不同伯氏疏螺旋体疫苗中重组OspA的免疫反应特征及其与功能参数的关系。
BMC Vet Res. 2018 Oct 16;14(1):312. doi: 10.1186/s12917-018-1625-7.
3
Epidemiology of Lyme disease.莱姆病流行病学
Infect Dis Clin North Am. 2015 Jun;29(2):187-210. doi: 10.1016/j.idc.2015.02.010.
4
A phylogenomic and molecular marker based proposal for the division of the genus Borrelia into two genera: the emended genus Borrelia containing only the members of the relapsing fever Borrelia, and the genus Borreliella gen. nov. containing the members of the Lyme disease Borrelia (Borrelia burgdorferi sensu lato complex).基于系统发育基因组学和分子标记的提议：将疏螺旋体属分为两个属，修订后的疏螺旋体属仅包含回归热疏螺旋体成员，新的伯氏疏螺旋体属包含莱姆病疏螺旋体（广义伯氏疏螺旋体复合体）成员。
Antonie Van Leeuwenhoek. 2014 Jun;105(6):1049-72. doi: 10.1007/s10482-014-0164-x. Epub 2014 Apr 18.
5
Construction and analysis of variants of a polyvalent Lyme disease vaccine: approaches for improving the immune response to chimeric vaccinogens.多价莱姆病疫苗变体的构建与分析：改善对嵌合疫苗抗原免疫反应的方法
Vaccine. 2007 Apr 30;25(17):3419-27. doi: 10.1016/j.vaccine.2006.12.051. Epub 2007 Jan 17.
6
Analysis of antibody response in humans to the type A OspC loop 5 domain and assessment of the potential utility of the loop 5 epitope in Lyme disease vaccine development.人类对A 型OspC环5结构域的抗体反应分析以及环5表位在莱姆病疫苗研发中的潜在效用评估。
Clin Vaccine Immunol. 2006 Oct;13(10):1162-5. doi: 10.1128/CVI.00099-06.
7
Development of an OspC-based tetravalent, recombinant, chimeric vaccinogen that elicits bactericidal antibody against diverse Lyme disease spirochete strains.开发一种基于OspC的四价重组嵌合疫苗原，该疫苗原可诱导针对多种莱姆病螺旋体菌株产生杀菌抗体。
Vaccine. 2007 Jan 5;25(3):466-80. doi: 10.1016/j.vaccine.2006.07.052. Epub 2006 Aug 8.
8
Temporal changes in outer surface proteins A and C of the lyme disease-associated spirochete, Borrelia burgdorferi, during the chain of infection in ticks and mice.莱姆病相关螺旋体伯氏疏螺旋体外表面蛋白A和C在蜱和小鼠感染链中的时间变化。
J Clin Microbiol. 2000 Jan;38(1):382-8. doi: 10.1128/JCM.38.1.382-388.2000.
9
Lyme disease-a tick-borne spirochetosis?莱姆病——一种蜱传播的螺旋体病？
Science. 1982 Jun 18;216(4552):1317-9. doi: 10.1126/science.7043737.
10
Spirochetes isolated from the blood of two patients with Lyme disease.从两名莱姆病患者血液中分离出的螺旋体。
N Engl J Med. 1983 Mar 31;308(13):740-2. doi: 10.1056/NEJM198303313081302.
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