Espul C, Benedetti L, Linares M, Cuello H, Rasuli A
Programa de lucha contra las hepatitis virales (PRHEVI), Ministerio de Salud/Hospital Central de Mendoza, Mendoza, Argentina.
J Viral Hepat. 2015 Apr;22(4):453-8. doi: 10.1111/jvh.12317. Epub 2014 Sep 29.
Our study was conducted to further investigate the single-dose approach of hepatitis A vaccination, while providing supportive data on the flexibility of booster administration. Participants received at least one dose of Avaxim 80U Pediatric at 11-23 months of age, and they will be followed for 10 years. We report here the fourth and fifth years after the first vaccination. Group assignment was based on whether the children received 1 dose and no booster during the study (Group 1) or 2 doses and no further booster (Group 2). Anti-HAV antibody concentrations were assessed at each annual visit. Of the 546 initial participants, 441 (80.8%) and 412 (75.5%) were followed up 4 and 5 years after vaccination, respectively. Of the 411 subjects evaluable at Year 5, 318 had received one vaccine dose and 85 had received two. Seroprotection rates were still high in Group 1 (99.7%) and in Group 2 (100%) 5 years after one or two doses of Avaxim 80U Pediatric, correspondingly. Anti-HAV geometric mean concentrations decreased in both groups compared to what they were 3 years after vaccination, while remaining well above the 10 mIU/mL threshold 5 years after vaccination. The highest concentrations were found in the children who received 2 vaccine doses. Hepatitis A humoral immunity induced by a single dose of inactivated hepatitis A vaccine can persist for at least 5 years in a paediatric population. The study results also support recommendations in favour of a flexible time window for booster vaccination.
我们开展这项研究是为了进一步探究甲型肝炎疫苗的单剂量接种方法,同时提供关于加强免疫接种灵活性的支持性数据。参与者在11至23月龄时至少接种一剂80U儿童用Avaxim疫苗,并将接受为期10年的随访。我们在此报告首次接种疫苗后的第四年和第五年的情况。分组是基于儿童在研究期间是否接种了1剂且未进行加强免疫(第1组)或接种了2剂且未进行进一步加强免疫(第2组)。每年随访时评估抗甲型肝炎病毒(HAV)抗体浓度。在546名初始参与者中,分别有441名(80.8%)和412名(75.5%)在接种疫苗后的第4年和第5年接受了随访。在第5年可评估的411名受试者中,318名接种了一剂疫苗,85名接种了两剂。相应地,在接种一剂或两剂80U儿童用Avaxim疫苗5年后,第1组(99.7%)和第2组(100%)的血清保护率仍然很高。与接种疫苗3年后相比,两组的抗HAV几何平均浓度均有所下降,但在接种疫苗5年后仍远高于10 mIU/mL的阈值。接种2剂疫苗的儿童中抗HAV浓度最高。单剂量灭活甲型肝炎疫苗诱导的甲型肝炎体液免疫在儿科人群中至少可持续5年。研究结果也支持关于加强免疫接种采用灵活时间窗的建议。