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Statistical modeling alongside observational data predicts long-term immunogenicity of one dose and two doses of pediatric hepatitis A vaccine in the Mendoza province of Argentina.
Vaccine ( IF 5.5 ) Pub Date : 2020-01-09 , DOI: 10.1016/j.vaccine.2019.12.049
C Espul 1 , H Cuello 2 , I Lo Castro 2 , C Bravo 3 , Y Thollot 3 , J Voznica 4 , C Vigne 3 , L Coudeville 3
Affiliation  

BACKGROUND Follow-up for anti-hepatitis A (HA) antibody persistence up to 10 years was conducted after implementation of universal vaccination against HA virus (HAV) in Mendoza, Argentina. Based on these data, statistical modeling was used to predict the antibody persistence to 30 years. METHODS A non-interventional study evaluated long-term immunogenicity (geometric mean concentrations [GMCs] and seroprotection rate) following routine vaccination with 1 dose (Group 1: N = 436) or 2 doses (Group 2: N = 108) of HA vaccine. Associated statistical modeling based on a Bayesian approach of mixed effects models on log transformed titers evaluated three models (linear, piecewise linear, and exponential decay, with and without a natural boosting effect). RESULTS From the initial cohort, 9 participants (Group 1) and 1 participant (Group 2) showed antibody titers below the seroprotective threshold and received a booster. At Year 10, 190 (Group 1) and 51 (Group 2) participants remained in the study without a booster dose and all were seroprotected. Regarding statistical modeling, the piecewise linear model showed the best fit and demonstrated high and similar seroprotection for each schedule up to 30 years (89% [1-dose schedule], 85% [2-dose schedule]). The 2-dose schedule showed higher GMC (95% CI) than the 1-dose schedule (Year 10: 352 [271-456] versus 78 [69.8-87.6] mIU/mL) and Year 30 (predicted) (37 [13-97] versus 19 [11-34] mIU/mL). Natural boosting had little impact on predicted seroprotection rates at 30 years for the 1-dose schedule (89% [0.8-0.96] and 84% [0.73-0.94] with and without a natural booster, respectively). CONCLUSIONS Long-term persistence of anti-HAV antibodies was observed up to 10 years with 1-dose and 2-dose vaccine schedules, supporting booster flexibility. Statistical modeling predicted good persistence of seroprotection for each schedule up to 30 years. Natural boosting had a limited impact on seroprotection rate predictions, enabling extrapolation of these results to non-endemic settings for traveler vaccination.

中文翻译:

统计模型与观察数据一起预测了阿根廷门多萨省一剂和两剂小儿甲型肝炎疫苗的长期免疫原性。

背景技术在阿根廷门多萨实施了针对HA病毒(HAV)的通用疫苗接种后,进行了长达10年的抗A型肝炎(HA)抗体持久性随访。基于这些数据,使用统计模型来预测抗体的持久性至30年。方法一项非干预性研究评估了常规疫苗接种1剂(组1:N = 436)或2剂(组2:N = 108)HA疫苗后的长期免疫原性(几何平均浓度[GMCs]和血清保护率)。 。基于对数转换滴定度的混合效应模型的贝叶斯方法的关联统计模型评估了三个模型(线性,分段线性和指数衰减,具有和不具有自然增强效果)。结果从最初的队列来看,9名参与者(第1组)和1名参与者(第2组)显示抗体滴度低于血清保护阈值并接受加强免疫。在第10年,有190名(第1组)和51名(第2组)参与者没有加强剂量就留在研究中,并且所有人都受到了血清保护。关于统计建模,分段线性模型显示了最合适的拟合,并显示了长达30年的每个计划的高度和相似的血清保护(89%[1剂量计划],85%[2剂量计划])。2剂量方案显示的GMC(95%CI)高于1剂量方案(第10年:352 [271-456]对78 [69.8-87.6] mIU / mL)和第30年(预计)(37 [13] -97]对19 [11-34] mIU / mL)。对于1剂给药方案,自然加强对30年的预期血清保护率几乎没有影响(分别使用和不使用自然加强剂时分别为89%[0.8-0.96]和84%[0.73-0.94])。结论使用1剂和2剂疫苗方案,可以观察到抗HAV抗体的长期持久性长达10年,从而支持了增强的灵活性。统计模型预测了每个计划中长达30年的良好血清保护作用。自然加强对血清保护率预测的影响有限,因此可以将这些结果外推到非流行性环境中以进行旅行者疫苗接种。
更新日期:2020-01-09
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