Van Der Wielen Marie, Vertruyen André, Froesner G, Ibáñez Rubén, Hunt Marjory, Herzog Christian, Van Damme Pierre
University of Antwerp, Antwerp, Belgium.
Pediatr Infect Dis J. 2007 Aug;26(8):705-10. doi: 10.1097/INF.0b013e31806215c8.
The availability of pediatric formulations of hepatitis A virus (HAV) vaccines would facilitate the introduction of universal mass vaccination against HAV. The objective of this study was to compare a pediatric dose (0.25 mL) of Epaxal, a virosomal, aluminum-free HAV vaccine, to 0.5 mL standard dose, and to alum-adsorbed HAV vaccine.
Subjects aged 1-16 years, stratified for age, were randomized (2:2:1) into group A (0.25 mL Epaxal), group B (0.5 mL Epaxal), or group C (Havrix Junior). Vaccines were administered at months 0, 6. Seroprotection rates (>or=10 mIU/mL anti-HAV antibodies) were assessed for noninferiority, defined as lower limit of 1-sided 97.5% CI >-10%. Incidence of local solicited adverse events and unsolicited adverse events were recorded.
Mean age of 308 enrolled subjects was 8.9 years (range, 1.0-17.0 years). All 3 vaccines were highly immunogenic. Noninferiority of group A versus group B and group C with regard to seroprotection was demonstrated after both vaccine doses for the entire study group and for all age subgroups (11-23 months, 2-4, 5-7, 8-10, 11-13, 14-16 years). One month after first vaccination, geometric mean antibody concentrations were 69.0, 83.5, and 50.5 mIU/mL for the 3 groups, respectively (A versus B, P = 0.0208; A versus C, P = 0.0015). Local injection site pain occurred more frequently in group C than in groups A and B. No subjects withdrew from study or reported any vaccine-related serious adverse event.
In children aged 1-16 years, 0.25 mL dose of Epaxal is as immunogenic as standard 0.5 mL dose and Havrix Junior. The aluminum-free vaccine compares favorably to comparator vaccine regarding local reactogenicity.
甲型肝炎病毒（HAV）疫苗儿科剂型的可获得性将有助于推行针对HAV的普遍大规模疫苗接种。本研究的目的是比较儿科剂量（0.25 mL）的Epaxal（一种无铝的病毒体HAV疫苗）与0.5 mL标准剂量以及吸附明矾的HAV疫苗。
将1至16岁的受试者按年龄分层，随机（2:2:1）分为A组（0.25 mL Epaxal）、B组（0.5 mL Epaxal）或C组（Havrix Junior）。疫苗在0、6个月时接种。评估血清保护率（抗-HAV抗体≥10 mIU/mL）的非劣效性，定义为单侧97.5%置信区间下限＞-10%。记录局部主动报告的不良事件和非主动报告的不良事件的发生率。
308名入组受试者的平均年龄为8.9岁（范围1.0 - 17.0岁）。所有三种疫苗均具有高度免疫原性。在整个研究组以及所有年龄亚组（11 - 23个月、2 - 4岁、5 - 7岁、8 - 10岁、11 - 13岁、14 - 16岁）的两剂疫苗接种后，均证明A组相对于B组和C组在血清保护方面具有非劣效性。首次接种疫苗1个月后，三组的几何平均抗体浓度分别为69.0、83.5和50.5 mIU/mL（A组与B组比较，P = 0.0208；A组与C组比较，P = 0.0015）。C组局部注射部位疼痛的发生频率高于A组和B组。没有受试者退出研究或报告任何与疫苗相关的严重不良事件。
在1至16岁儿童中，0.25 mL剂量的Epaxal与标准的0.5 mL剂量以及Havrix Junior具有相同的免疫原性。在局部反应原性方面，这种无铝疫苗优于对照疫苗。
