Wysocki Jacek, Brzostek Jerzy, Szymański Henryk, Tetiurka Bogusław, Toporowska-Kowalska Ewa, Wasowska-Królikowska Krystyna, Sarkozy Denise A, Giardina Peter C, Gruber William C, Emini Emilio A, Scott Daniel A
Department of Preventive Medicine, Poznan University of Medical Sciences, ul. Smoluchowskiego 11, 60-179 Poznan, Poland.
NZOZ w Debicy, Poradnia, Debica, Poland.
Vaccine. 2015 Mar 30;33(14):1719-25. doi: 10.1016/j.vaccine.2015.02.005. Epub 2015 Feb 17.
Streptococcus pneumoniae infections are a major cause of morbidity and mortality in children <5 years old worldwide. To increase serotype coverage globally, a 13-valent pneumococcal conjugate vaccine (PCV13) has been developed and approved in many countries worldwide.
Assess the safety and immunogenicity of PCV13 in healthy older infants and children naïve to previous pneumococcal vaccination.
This was a phase 3, open-label, multicenter study conducted in Polish children (N=354) who were vaccinated according to 3 age-appropriate catch-up schedules: Group 1 (aged 7 to <12 months) received two PCV13 doses with a booster at 12-16 months of age; Group 2 (aged 12 to <24 months) received two vaccine doses only; and Group 3 (aged 24 to <72 months) received a single dose of PCV13. Statistical analyses were descriptive. The proportion of immunological "responders" achieving serotype-specific antipneumococcal polysaccharide concentrations ≥0.35μg/mL, 1-month after the last dose of vaccine, was determined for each vaccine serotype. In addition, antipolysaccharide immunoglobulin (Ig) G geometric mean concentrations (GMCs) were calculated. Safety assessments included systemic and local reactions, and adverse events.
The proportion of immunological responders was ≥88% across groups for all serotypes. Antipolysaccharide IgG GMCs were generally similar across groups. Each schedule elicited immune response levels against all 13 serotypes comparable to or greater than levels previously reported in infants after a 3-dose series. The 3 catch-up schedules had similar tolerability and safety profiles; a trend was present towards greater local tenderness with increasing age and subsequent dose administration.
Immunological responses and safety results support the use of PCV13 for catch-up schedules in older infants and children naïve to pneumococcal vaccination.
肺炎链球菌感染是全球5岁以下儿童发病和死亡的主要原因。为了在全球范围内提高血清型覆盖率，已研发出13价肺炎球菌结合疫苗（PCV13）并在世界许多国家获得批准。
评估PCV13在既往未接种过肺炎球菌疫苗的健康大龄婴儿和儿童中的安全性和免疫原性。
这是一项在波兰儿童中进行的3期、开放标签、多中心研究（N = 354），这些儿童按照3种适合年龄的补种程序进行接种：第1组（7至<12月龄）接种2剂PCV13，并在12 - 16月龄时加强接种1剂；第2组（12至<24月龄）仅接种2剂疫苗；第3组（24至<72月龄）接种1剂PCV13。统计分析为描述性分析。在最后一剂疫苗接种1个月后，针对每种疫苗血清型，确定血清型特异性抗肺炎球菌多糖浓度≥0.35μg/mL的免疫“应答者”比例。此外，计算抗多糖免疫球蛋白（Ig）G几何平均浓度（GMC）。安全性评估包括全身和局部反应以及不良事件。
所有血清型在各年龄组中的免疫应答者比例均≥88%。各年龄组的抗多糖IgG GMC总体相似。每种接种程序引发的针对所有13种血清型的免疫反应水平与先前报道的婴儿3剂接种系列后的水平相当或更高。这3种补种程序具有相似的耐受性和安全性特征；随着年龄增长和后续接种剂量增加，局部压痛有增加的趋势。
免疫反应和安全性结果支持在既往未接种过肺炎球菌疫苗的大龄婴儿和儿童中使用PCV13进行补种程序。
