13价肺炎球菌结合疫苗在炎症性肠病儿科患者中的免疫原性
Immunogenicity of 13-Valent Pneumococcal Conjugate Vaccine in Pediatric Patients with Inflammatory Bowel Disease.
作者信息
Banaszkiewicz Aleksandra, Targońska Brygida, Kowalska-Duplaga Kinga, Karolewska-Bochenek Katarzyna, Sieczkowska Agnieszka, Gawrońska Agnieszka, Grzybowska-Chlebowczyk Urszula, Krzesiek Elżbieta, Łazowska-Przeorek Izabella, Kotowska Maria, Sienkiewicz Edyta, Walkowiak Jarosław, Gregorek Hanna, Radzikowski Andrzej, Albrecht Piotr
机构信息
*Department of Pediatric Gastroenterology and Nutrition, Medical University of Warsaw, Warsaw, Poland; †Department of Pediatric Gastroenterology and Metabolic Diseases, Poznan University of Medical Sciences, Poznan, Poland; ‡Department of Pediatrics, Gastroenterology and Nutrition, Polish-American Children's Hospital, Jagiellonian University Medical College, Krakow, Poland; §Department of Pediatric Gastroenterology, Hepatology and Nutrition, Medical University of Gdansk, Gdansk, Poland; ‖Department of Pediatrics, Medical University of Silesia, Katowice, Poland; ¶Department of Pediatrics, Gastroenterology and Nutrition, Wroclaw Medical University, Wroclaw, Poland; and **Department of Microbiology and Clinical Immunology, The Children's Memorial Health Institute, Warsaw, Poland.
出版信息
Inflamm Bowel Dis. 2015 Jul;21(7):1607-14. doi: 10.1097/MIB.0000000000000406.
BACKGROUND
There are only a few studies on immune response to pneumococcal vaccines in patients with inflammatory bowel disease (IBD); all of them assessed polysaccharide vaccines only. The aim of the study was to evaluate the immunogenicity and safety of 13-valent pneumococcal conjugate vaccine (PCV13) in IBD pediatric patients compared with healthy controls.
METHODS
This was a multicenter, prospective, and controlled study on children and adolescents aged 5 to 18 years with IBD with no history of pneumococcal immunization. The subjects for the study belonged to one of the following groups: patients with IBD on no immunosuppressive therapy (group A), those on tumor necrosis factor agents or immunomodulators (group B), and healthy controls (group C). The study population received 1 intramuscular injection of PCV13. The primary outcome measure was adequate vaccine response defined as postvaccination titer ≥0.35 μg/mL to all 13 serotypes. Geometric mean titers and geometric mean titer rises were measured for all serotypes. The evidence of local and systemic adverse effects for 5 days after the vaccine was registered.
RESULTS
A total of 178 subjects (122 patients and 56 controls) completed the study course. There was no significant difference in the rate of adequate vaccine response between patients with IBD and controls measured 4 to 8 weeks after vaccination (90.4% versus 96.5%, P = 0.5281). Children in group A had higher geometric mean titer rises than children in group B (P = 0.0369). There were no serious adverse events related to PCV13 during the study.
CONCLUSIONS
PCV13 is both immunogenic and safe in pediatric patients with IBD.
背景
关于炎症性肠病（IBD）患者对肺炎球菌疫苗的免疫反应的研究较少；所有这些研究仅评估了多糖疫苗。本研究的目的是评估13价肺炎球菌结合疫苗（PCV13）在IBD儿科患者中与健康对照相比的免疫原性和安全性。
方法
这是一项针对5至18岁未接种过肺炎球菌疫苗的IBD儿童和青少年的多中心、前瞻性对照研究。研究对象属于以下组之一：未接受免疫抑制治疗的IBD患者（A组）、接受肿瘤坏死因子药物或免疫调节剂治疗的患者（B组）和健康对照（C组）。研究人群接受1次PCV13肌肉注射。主要结局指标是充分的疫苗反应，定义为接种疫苗后对所有13种血清型的滴度≥0.35μg/mL。测量所有血清型的几何平均滴度和几何平均滴度升高。记录疫苗接种后5天内局部和全身不良反应的证据。
结果
共有178名受试者（122名患者和56名对照）完成了研究过程。接种疫苗后4至8周测量，IBD患者和对照之间充分疫苗反应的发生率没有显著差异（90.4%对96.5%，P = 0.5281）。A组儿童的几何平均滴度升高高于B组儿童（P = 0.0369）。研究期间没有与PCV13相关的严重不良事件。
结论
PCV13在IBD儿科患者中具有免疫原性且安全。
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