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13价肺炎球菌结合疫苗(PCV13)在6至17岁曾接种23价肺炎球菌多糖疫苗(PPSV23)的镰状细胞病患儿中具有免疫原性且安全:一项3期研究的结果

13-valent pneumococcal conjugate vaccine (PCV13) is immunogenic and safe in children 6-17 years of age with sickle cell disease previously vaccinated with 23-valent pneumococcal polysaccharide vaccine (PPSV23): Results of a phase 3 study.

作者信息

De Montalembert Mariane, Abboud Miguel R, Fiquet Anne, Inati Adlette, Lebensburger Jeffrey D, Kaddah Normeen, Mokhtar Galila, Piga Antonio, Halasa Natasha, Inusa Baba, Rees David C, Heath Paul T, Telfer Paul, Driscoll Catherine, Al Hajjar Sami, Tozzi Alberto, Jiang Qin, Emini Emilio A, Gruber William C, Gurtman Alejandra, Scott Daniel A

机构信息

Hôpital Necker-Enfants Malades, Service de Pédiatrie, Paris, France.

Department of Pediatrics and Adolescent Medicine, American University of Beirut, Beirut, Lebanon.

出版信息

Pediatr Blood Cancer. 2015 Aug;62(8):1427-36. doi: 10.1002/pbc.25502. Epub 2015 Mar 23.

DOI:10.1002/pbc.25502
PMID:25810327
Abstract

BACKGROUND

A large population of older children with sickle cell disease (SCD) is currently vaccinated with only 23-valent pneumococcal polysaccharide vaccine (PPSV23). In immunocompetent adults, PPSV23 vaccination reduces immune responses to subsequent vaccination with a pneumococcal vaccine. The 13-valent pneumococcal conjugate vaccine (PCV13), which addresses this limitation, may offer an advantage to this population at high risk of pneumococcal disease.

PROCEDURE

Children with SCD 6-17 years of age previously vaccinated with PPSV23 at least 6 months before study enrollment received two doses of PCV13 6 months apart. Anti-pneumococcal polysaccharide immunoglobulin G (IgG) geometric mean concentrations (GMCs) and opsonophagocytic activity (OPA) geometric mean titers (GMTs) were measured before, 1 month after each administration, and 1 year after the second administration.

RESULTS

Following each PCV13 administration, IgG GMCs and OPA GMTs significantly increased, and antibody levels after doses 1 and 2 were generally comparable. Antibody levels declined over the year following dose 2. At 1 year after the second administration, OPA GMTs for all and IgG GMCs for most serotypes remained above pre-vaccination levels. Most adverse events were due to vaso-occlusive crises, a characteristic of the underlying condition of SCD.

CONCLUSIONS

Children with SCD who were previously vaccinated with PPSV23 responded well to 1 PCV13 dose, and a second dose did not increase antibody response. PCV13 antibodies persisted above pre-vaccination levels for all serotypes 1 year after dose 2. Children with SCD may benefit from at least one dose of PCV13.

摘要

背景

目前,大量患有镰状细胞病(SCD)的大龄儿童仅接种了23价肺炎球菌多糖疫苗(PPSV23)。在免疫功能正常的成年人中,接种PPSV23会降低对后续肺炎球菌疫苗接种的免疫反应。13价肺炎球菌结合疫苗(PCV13)解决了这一局限性,可能对这一肺炎球菌疾病高危人群具有优势。

程序

年龄在6至17岁、在研究入组前至少6个月已接种PPSV23的SCD患儿,每隔6个月接种两剂PCV13。在每次接种前、接种后1个月以及第二次接种后1年测量抗肺炎球菌多糖免疫球蛋白G(IgG)几何平均浓度(GMC)和调理吞噬活性(OPA)几何平均滴度(GMT)。

结果

每次接种PCV13后,IgG GMC和OPA GMT均显著升高,第1剂和第2剂后的抗体水平总体相当。第2剂接种后的一年中抗体水平下降。在第二次接种后1年,所有血清型的OPA GMT以及大多数血清型的IgG GMC仍高于接种前水平。大多数不良事件归因于血管闭塞性危机,这是SCD潜在病症的一个特征。

结论

先前接种过PPSV23的SCD患儿对1剂PCV13反应良好,第2剂并未增加抗体反应。第2剂接种后1年,所有血清型的PCV13抗体均维持在接种前水平之上。SCD患儿可能至少从1剂PCV13接种中获益。

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