论文部分内容阅读
背景多组分血清B群脑膜炎球菌疫苗(4CMenB)最近在欧洲获准使用。目前还缺乏婴儿期使用此疫苗后产生杀菌抗体存留性的证据。此研究将对40~44个月,在2、4、6、12个月接种过4CMenB的儿童进行评估。方法参试者婴儿期均接受过4个剂量的4CMenB,并在40~44个月接受第5个剂量。首次接受4CMenB年龄匹配的参试者作为对照组。对人类完全血清杀菌力(hSBA)滴度进行基线及4CMenB每个剂量接种后1个月的评估。结果在追加剂量前,17名参试者中有41%~76%在婴儿期接种过4CMenB,对比4个参考菌株hSBA滴度≥4。对照组(n=40)接种前这些菌株比例相似4/76-SL(63%)及M10713(68%),但菌株NZ98/254(0)及5/99(3%)比例要低。与对照组相比,做4CMenB追加剂量参试者的hSBA滴度上升得要多。解释根据获准婴儿接种计划,即2、4、6、12个月接种疫苗,就像其他脑膜炎球菌疫苗,接种4CMenB后,杀菌抗体也会减少,但40~44个月追加剂量后出现了抗体增生反应。如果将4CMenB列入常规疫苗接种计划,对追加剂量的评估还需要下降滴度影响疫苗效力的相关数据。
Background Multicomponent serogroup B meningococcal vaccine (4CMenB) has recently been approved for use in Europe. There is also a lack of evidence of bactericidal antibody persistence after this vaccine is used in infancy. This study will evaluate children aged 40 to 44 months who have been vaccinated at 4, 5, 5, 6 months at 2, 4, 6, 12 months. METHODS Subjects received 4 doses of 4CMenB in infancy and a fifth dose in 40-44 months. For the first time 4CMenB age-matched participants as controls. Human complete serum bactericidal (hSBA) titers were baseline and 1 week after 4CMenB injections of each dose. Results Before additional dose, 41% to 76% of 17 participants had been vaccinated with 4CMenB in infancy and 4 hSBA titer compared to 4 reference strains. The control strains (n = 40) had similar proportions of 4/76-SL (63%) and M10713 (68%) prior to inoculation but strains NZ98 / 254 (0) and 5/99 (3%) were lower in proportion. Compared with the control group, 4SenB additional dose of hSBA titers increased much more. Interpretation Vaccination under approved infant vaccination programs, ie 2, 4, 6, 12 months, just like other meningococcal vaccines, resulted in a decrease in bactericidal antibodies after vaccination with 4CMenB, but antibodies were present after additional doses of 40 to 44 months Hyperplasia reaction. If 4CMenB is included in a routine vaccination program, the assessment of additional doses will also need to reduce the titer to affect the efficacy of the vaccine.