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Anthrax vaccine adsorbed: Further evidence supporting continuing the vaccination series rather than restarting the series when doses are delayed

机译:吸附的炭疽疫苗:进一步的证据支持继续接种系列疫苗,而不是在剂量延迟后重新开始接种

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摘要

Whether to restart or continue the series when anthrax vaccine doses are missed is a frequent medical management problem. We applied the noninferiority analysis model to this prospective study comparing the Bacillus anthracis protective antigen (PA) IgG antibody response and lethal toxin neutralization activity at day 28 to the anthrax vaccine adsorbed (AVA) (Biothrax (R)) administered on schedule or delayed. A total of 600 volunteers were enrolled: 354 in the on-schedule cohort; 246 in the delayed cohort. Differences were noted in immune responses between cohorts (p < 0.0001) and among the racial categories (p < 0.0001). Controlling for covariates, the delayed cohort was non-inferior to the on-schedule cohort for the rate of 4-fold rise in both anti-PA IgG concentration (p < 0.0001) and TNA ED50 titers (p < 0.0001); as well as the mean log(10)-transformed anti-PA IgG concentration (p < 0.0001) and the mean log10-transformed TNA ED50 titers (p < 0.0001). Providing a missed AVA dose after a delay as long as 5-7 years, elicits anti-PA IgG antibody and TNA ED50 responses that are robust and non-inferior to the responses observed when the 6-month dose is given on-schedule. These important data suggest it is not necessary to restart the series when doses of the anthrax vaccine are delayed as long as 5 or more years
机译:当错过炭疽疫苗剂量时是否重新开始或继续该系列是常见的医疗管理问题。我们在这项前瞻性研究中应用了非劣效性分析模型,比较了按计划或延迟施用的炭疽疫苗吸附(AVA)(Biothrax(R))第28天的炭疽芽孢杆菌保护性抗原(PA)IgG抗体反应和致命毒素中和活性。总共招募了600名志愿者:计划内队列中的354名;延迟队列中为246。队列之间(p <0.0001)和种族类别(p <0.0001)之间的免疫反应存在差异。控制协变量,抗PA IgG浓度(p <0.0001)和TNA ED50滴度(p <0.0001)的4倍上升速率,延迟的队列均不逊于按计划的队列。以及平均log(10)转化的抗PA IgG浓度(p <0.0001)和平均log10转化的TNA ED50滴度(p <0.0001)。在延迟长达5-7年后提供错过的AVA剂量,会引起抗PA IgG抗体和TNA ED50反应,这些反应既牢固又不逊于按计划给予6个月剂量时观察到的反应。这些重要数据表明,当炭疽疫苗的剂量延迟长达5年或更长时间时,无需重新开始该系列疫苗

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