Lang J, Zuckerman J, Clarke P, Barrett P, Kirkpatrick C, Blondeau C
Pasteur Mérieux Connaught, Lyon, France.
Am J Trop Med Hyg. 1999 Jun;60(6):1045-50. doi: 10.4269/ajtmh.1999.60.1045.
As part of the clinical validation process of a new working seed of a licensed yellow fever vaccine (new working seed PV26, Stamaril; Pasteur Mérieux Connaught, Lyon, France), the immunogenicity and safety of two batches of this vaccine (PM-YF) were compared with those of another commercially available vaccine (Arilvax; Evans Medical-Wellcome, Liverpool, United Kingdom) in 211 healthy adults. While the geometric mean titer values at days 10-14 and day 28 after vaccination were higher in the PM-YF group, the vaccines provided equivalent seroprotection (titers > or = 1/10) one month after a single vaccine dose (100% PM-YF versus 99% W-YF; P = 0.001, by one-sided equivalence test). Both vaccines were safe. There were no serious local or systemic reactions reported, nor any clinically significant hepatic function abnormalities associated with the use of either vaccine. These two 17D yellow fever vaccines from different European vaccine manufacturers were highly immunogenic and safe, and provided equivalent seroprotection.
作为一种已获许可的黄热病疫苗新工作种子株(新工作种子株PV26,Stamaril;巴斯德梅里厄康诺公司,法国里昂)临床验证过程的一部分,在211名健康成年人中,将两批这种疫苗(PM-YF)的免疫原性和安全性与另一种市售疫苗(Arilvax;埃文斯医学-威康公司,英国利物浦)进行了比较。虽然接种疫苗后第10 - 14天和第28天PM-YF组的几何平均滴度值较高,但在单剂疫苗接种一个月后,两种疫苗提供了等效的血清保护作用(滴度>或 = 1/10)(PM-YF为100%,W-YF为99%;通过单侧等效性检验,P = 0.001)。两种疫苗均安全。未报告严重的局部或全身反应,也未发现与使用任何一种疫苗相关的任何具有临床意义的肝功能异常。这两种来自不同欧洲疫苗制造商的17D黄热病疫苗具有高度免疫原性且安全,并提供了等效的血清保护作用。