Marconi Richard T, Honsberger Nicole, Teresa Winkler M, Sobell Nikki, King Vickie L, Wappel Sharon, Hoevers Jacquelien, Xu Zach, Millership Jason
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.
Vaccine X. 2020 Oct 22;6:100080. doi: 10.1016/j.jvacx.2020.100080. eCollection 2020 Dec 11.
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.
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。
