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Prevention and control of influenza with vaccines: recommendations of the Advisory Committee on Immunization Practices (ACIP), 2011.疫苗预防和控制流感:免疫实践咨询委员会(ACIP)的建议,2011 年。
MMWR Morb Mortal Wkly Rep. 2011 Aug 26;60(33):1128-32.
2
Oseltamivir-induced resistant pandemic A/H1N1 influenza virus in a child with cystic fibrosis and Pseudomonas aeruginosa infection.奥司他韦诱导的囊性纤维化合并铜绿假单胞菌感染患儿的耐药大流行 A/H1N1 流感病毒。
J Clin Virol. 2010 May;48(1):62-5. doi: 10.1016/j.jcv.2010.02.019. Epub 2010 Mar 23.
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Cross-reactive antibody responses to the 2009 A/H1N1v influenza virus in the Italian population in the pre-pandemic period.大流行前时期意大利人群中对 2009 年 A/H1N1v 流感病毒的交叉反应性抗体应答。
Vaccine. 2010 Apr 30;28(20):3558-62. doi: 10.1016/j.vaccine.2010.03.006. Epub 2010 Mar 20.
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Immunogenicity of a monovalent 2009 influenza A(H1N1) vaccine in infants and children: a randomized trial.婴幼儿接种单价 2009 年甲型 H1N1 流感疫苗的免疫原性:一项随机试验。
JAMA. 2010 Jan 6;303(1):37-46. doi: 10.1001/jama.2009.1911. Epub 2009 Dec 21.
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Safety and immunogenicity of a 2009 pandemic influenza A H1N1 vaccine when administered alone or simultaneously with the seasonal influenza vaccine for the 2009-10 influenza season: a multicentre, randomised controlled trial.2009 年甲型 H1N1 流感大流行疫苗单独或与 2009-10 年流感季节季节性流感疫苗同时接种的安全性和免疫原性:一项多中心、随机对照试验。
Lancet. 2010 Jan 2;375(9708):49-55. doi: 10.1016/S0140-6736(09)62039-0. Epub 2009 Dec 15.
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Large trials confirm immunogenicity of H1N1 vaccines.大型试验证实了甲型H1N1流感疫苗的免疫原性。
Lancet. 2010 Jan 2;375(9708):6-9. doi: 10.1016/S0140-6736(09)62132-2. Epub 2009 Dec 15.
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Safety and immunogenicity of 2009 pandemic influenza A H1N1 vaccines in China: a multicentre, double-blind, randomised, placebo-controlled trial.中国 2009 年甲型 H1N1 流感疫苗的安全性和免疫原性:一项多中心、双盲、随机、安慰剂对照试验。
Lancet. 2010 Jan 2;375(9708):56-66. doi: 10.1016/S0140-6736(09)62003-1. Epub 2009 Dec 15.
8
Impact of influenza-like illness and effectiveness of influenza vaccination in oncohematological children who have completed cancer therapy.完成癌症治疗的肿瘤血液病儿童中流感样疾病的影响和流感疫苗的有效性。
Vaccine. 2010 Feb 10;28(6):1558-65. doi: 10.1016/j.vaccine.2009.11.055. Epub 2009 Dec 8.
9
Guidance on novel influenza A/H1N1 in solid organ transplant recipients.新型甲型 H1N1 流感在实体器官移植受者中的指南。
Am J Transplant. 2010 Jan;10(1):18-25. doi: 10.1111/j.1600-6143.2009.02960.x. Epub 2009 Dec 2.
10
A novel influenza A (H1N1) vaccine in various age groups.在不同年龄组中使用新型甲型 H1N1 流感疫苗。
N Engl J Med. 2009 Dec 17;361(25):2414-23. doi: 10.1056/NEJMoa0908535. Epub 2009 Oct 21.

一项评估大流行流感 A/H1N1 MF59 佐剂疫苗与季节性病毒体佐剂流感疫苗序贯或同时接种于儿科肾移植受者的免疫原性、安全性和耐受性的开放性、随机临床试验。

An open-label, randomized clinical trial assessing immunogenicity, safety and tolerability of pandemic influenza A/H1N1 MF59-adjuvanted vaccine administered sequentially or simultaneously with seasonal virosomal-adjuvanted influenza vaccine to paediatric kidney transplant recipients.

机构信息

Department of Maternal and Pediatric Sciences, Università degli Studi di Milano, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.

出版信息

Nephrol Dial Transplant. 2011 Jun;26(6):2018-24. doi: 10.1093/ndt/gfq657. Epub 2010 Oct 25.

DOI:10.1093/ndt/gfq657
PMID:20974645
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7313880/
Abstract

BACKGROUND

The aim of this study was to investigate the immunogenicity, safety and tolerability of the 2009 A/H1N1 MF59-adjuvanted influenza vaccine, administered sequentially or simultaneously with the seasonal 2009-10 virosomal-adjuvanted influenza vaccine, to paediatric kidney transplant recipients.

METHODS

Thirty-two children and adolescents with transplanted kidneys and 32 age- and gender-matched healthy controls were randomized 1:1 to receive the pandemic vaccine upon enrolment and the seasonal vaccine 1 month later (16 transplant recipients and 16 healthy controls), or to receive the two vaccines simultaneously upon enrolment (16 transplant recipients and 16 healthy controls).

RESULTS

When the pandemic vaccine was administered sequentially to the seasonal vaccine, it was significantly less immunogenic in the patients than in the controls (P < 0.05); when it was administered together with the seasonal vaccine, the immune response of both patients (P < 0.05) and controls (P < 0.05) was significantly greater than when it was administered sequentially. Seroconversion rates and the geometric mean titres of all of the seasonal antigens were significantly lower in the patients, regardless of the type of vaccine administration (P < 0.05). Simultaneous administration was associated with a better immune response against A/H1N1 and A/H3N2 antigens in both patients and controls, and did not increase the mild local and systemic reactions. No impact on renal function was observed.

CONCLUSIONS

Paediatric kidney transplant recipients have a lower immune response to the pandemic influenza A/H1N1 MF59-adjuvanted and seasonal virosomal-adjuvanted influenza vaccines than healthy controls. The simultaneous administration of the two vaccines seems to increase immune response to both pandemic and seasonal A/H1N1 and A/H3N2 antigens, and has the same safety profile as that of the pandemic vaccine administered sequentially to the seasonal vaccine.

摘要

背景

本研究旨在探讨 MF59 佐剂 2009 年 A/H1N1 流感疫苗在先后或同时接种季节性 2009-10 年病毒样流感疫苗时,对儿科肾移植受者的免疫原性、安全性和耐受性。

方法

32 名肾移植儿童和青少年及 32 名年龄和性别匹配的健康对照者按 1:1 随机分为两组,一组在入组时接种大流行疫苗,1 个月后接种季节性疫苗(16 例移植受者和 16 例健康对照者),另一组在入组时同时接种两种疫苗(16 例移植受者和 16 例健康对照者)。

结果

当大流行疫苗先后接种于季节性疫苗时,患者的免疫原性明显低于对照组(P < 0.05);当与季节性疫苗同时接种时,患者(P < 0.05)和对照组(P < 0.05)的免疫反应均显著大于先后接种的情况。无论接种何种疫苗,患者的季节性抗原血清转化率和几何平均滴度均明显低于对照组(P < 0.05)。

同时接种与患者和对照组对 A/H1N1 和 A/H3N2 抗原产生更好的免疫反应相关,且不会增加轻微的局部和全身反应。未观察到对肾功能的影响。

结论

儿科肾移植受者对大流行流感 A/H1N1 MF59 佐剂和季节性病毒样佐剂流感疫苗的免疫反应低于健康对照者。同时接种两种疫苗似乎可以增加对大流行和季节性 A/H1N1 和 A/H3N2 抗原的免疫反应,且与大流行疫苗先后接种于季节性疫苗的安全性相似。