■本研究旨在比较中国目前的埃森狂犬病暴露后免疫接种计划(0-3-7-14-28)和世界卫生组织新推荐的简单4剂量计划(0-3-7-14)的安全性,功效,和保护。
■根据不同的免疫计划给小鼠接种疫苗,首次免疫后第14、21、28、35和120天采集血液检测狂犬病病毒中和抗体(RVNA)。此外,不同组的小鼠在第0天注射致死剂量的CVS-11病毒,接受不同的狂犬病免疫计划,并评估发病率和死亡状况。在临床试验中,根据埃森时间表,选择185名狂犬病暴露者进行暴露后疫苗接种,在第一次免疫后第28天和第42天收集血液用于RVNA检测。
■在第35天观察到Essen和0-3-7-14方案组的小鼠之间的RVNA在统计学上有显着差异(P<0.05)。0-3-7-14、0-3-7-21和0-3-7-28组在任何时间点的RVNA水平均无统计学差异(P>0.05)。暴露后免疫保护性试验显示,对照组小鼠存活率为20%,而免疫组的比例为40%。在临床试验中,第28天(4次剂量后14天)和第42天(5次剂量后14天)的RVNA阳性转化率均为100%,RVNAs水平差异无统计学意义(P>0.05)。
■简单的4剂量时间表可以产生足够的RVNA水平,延迟第四次疫苗剂量(14-28d)对免疫潜力没有显着影响。
UNASSIGNED: This
study aimed to compare the current Essen rabies post-exposure immunization schedule (0-3-7-14-28) in China and the simple 4-dose schedule (0-3-7-14) newly recommended by the World Health Organization in terms of their safety, efficacy, and protection.
UNASSIGNED: Mice were vaccinated according to different immunization schedules, and blood was collected for detection of rabies virus neutralizing antibodies (RVNAs) on days 14, 21, 28, 35, and 120 after the first immunization. Additionally, different groups of mice were injected with lethal doses of the CVS-11 virus on day 0, subjected to different rabies immunization schedules, and assessed for morbidity and death status. In a clinical
trial, 185 rabies-exposed individuals were selected for post-exposure vaccination according to the Essen schedule, and blood was collected for RVNAs detection on days 28 and 42 after the first immunization.
UNASSIGNED: A statistically significant difference in RVNAs between mice in the Essen and 0-3-7-14 schedule groups was observed on the 35th day ( P < 0.05). The groups 0-3-7-14, 0-3-7-21, and 0-3-7-28 showed no statistically significant difference ( P > 0.05) in RVNAs levels at any time point. The post-exposure immune protective test showed that the survival rate of mice in the control group was 20%, whereas that in the immunization groups was 40%. In the clinical
trial, the RVNAs positive conversion rates on days 28 (14 days after 4 doses) and 42 (14 days after 5 doses) were both 100%, and no significant difference in RVNAs levels was observed ( P > 0.05).
UNASSIGNED: The simple 4-dose schedule can produce sufficient RVNAs levels, with no significant effect of a delayed fourth vaccine dose (14-28 d) on the immunization potential.