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一种研究用四价脑膜炎球菌结合疫苗在婴儿和幼儿中接种 1 或 2 剂后的安全性和免疫原性。

Safety and immunogenicity of an investigational quadrivalent meningococcal conjugate vaccine after one or two doses given to infants and toddlers.

机构信息

Clinical Trials Research Center, Canadian Center for Vaccinology, Dalhousie University and the IWK Health Centre, 5850/5980 University Avenue, Halifax, NS, B3K 6R8, Canada.

出版信息

Eur J Clin Microbiol Infect Dis. 2010 Mar;29(3):259-67. doi: 10.1007/s10096-009-0848-8. Epub 2009 Dec 22.

DOI:10.1007/s10096-009-0848-8
PMID:20033465
Abstract

With the emergence of multiple meningococcal serogroups in different geographic areas, broad vaccine protection from infancy is desirable. One hundred and seventy-five infants received either two doses of a meningococcal quadrivalent (A, C, W-135, Y) conjugate vaccine (MenACWY-CRM) at 6 and 12 months, one dose of MenACWY-CRM at 12 months, or MenC at 12 months and MenACWY-CRM at 18 months. Bactericidal antibody titers using human complement were measured before and 1 month after each dose. Injection-site reactions were reported by 22-45% of participants following MenACWY-CRM given at 6 or 12 months. Similar proportions of subjects had injection-site reactions following two doses of MenACWY-CRM (32-41%) or one dose of MenC (26-44%). The incidence of systemic adverse events was comparable between groups. After two doses of MenACWY-CRM, the percentages of participants reporting hSBA titers >or=8 were 100% for C, W-135, and Y, and 84% for A. Serogroup C titers were more than 10-fold higher after two doses of MenACWY-CRM than after one dose of MenC or MenACWY-CRM at 12 months. Serogroup C titers were comparable following a single dose of MenACWY-CRM or MenC at 12 months. MenACWY-CRM is well tolerated and immunogenic given at 12 months, or two doses at 6 and 12 months of age.

摘要

随着不同地理区域中出现多种脑膜炎奈瑟菌血清群,从婴儿期开始广泛的疫苗保护是理想的。175 名婴儿分别在 6 个月和 12 个月时接受了两剂脑膜炎球菌四价(A、C、W-135、Y)结合疫苗(MenACWY-CRM)、12 个月时接受一剂 MenACWY-CRM、或 12 个月时接种 MenC 和 18 个月时接种 MenACWY-CRM。在每次接种前和接种后 1 个月,用人补体测量杀菌抗体滴度。在 6 个月或 12 个月时接种 MenACWY-CRM 后,22%-45%的参与者报告出现注射部位反应。接种两剂 MenACWY-CRM(32%-41%)或一剂 MenC(26%-44%)的受试者有相似比例出现注射部位反应。各组之间的全身不良事件发生率相当。接种两剂 MenACWY-CRM 后,报告 hSBA 滴度≥8 的参与者百分比为 C、W-135 和 Y 组为 100%,A 组为 84%。与 12 个月时接种一剂 MenC 或 MenACWY-CRM 相比,接种两剂 MenACWY-CRM 后血清群 C 滴度提高了 10 多倍。在 12 个月时接种一剂 MenACWY-CRM 或 MenC 后,血清群 C 滴度相当。在 12 个月时接种一剂或两剂 MenACWY-CRM 时,MenACWY-CRM 具有良好的耐受性和免疫原性。

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本文引用的文献

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Immunogenicity and immune memory of a nonadjuvanted quadrivalent meningococcal glycoconjugate vaccine in infants.无佐剂四价脑膜炎球菌糖共轭疫苗在婴儿中的免疫原性和免疫记忆
Pediatr Infect Dis J. 2009 Mar;28(3):186-93. doi: 10.1097/INF.0b013e31818e037d.
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Demonstration of immunologic memory using serogroup C meningococcal glycoconjugate vaccine.
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Immunogenicity of a tetravalent meningococcal glycoconjugate vaccine in infants: a randomized controlled trial.一种四价脑膜炎球菌糖共轭疫苗在婴儿中的免疫原性:一项随机对照试验。
UPDATE ON THE USE OF QUADRIVALENT CONJUGATE MENINGOCOCCAL VACCINES: An Advisory Committee Statement (ACS) National Advisory Committee on Immunization (NACI).四价结合型脑膜炎球菌疫苗使用情况更新:免疫国家咨询委员会(NACI)的咨询委员会声明(ACS)
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Hum Vaccin Immunother. 2014;10(8):2471-81. doi: 10.4161/hv.29571.
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Randomized trial to assess the immunogenicity, safety and antibody persistence up to three years after a single dose of a tetravalent meningococcal serogroups A, C, W-135 and Y tetanus toxoid conjugate vaccine in toddlers.在幼儿中单次接种四价脑膜炎球菌血清型 A、C、W-135 和 Y 破伤风类毒素结合疫苗后三年的免疫原性、安全性和抗体持久性的随机试验。
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Revised recommendations of the Advisory Committee on Immunization Practices to Vaccinate all Persons Aged 11-18 Years with Meningococcal Conjugate Vaccine.免疫实践咨询委员会修订后的建议:为所有11至18岁人群接种脑膜炎球菌结合疫苗。
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Modeling future changes to the meningococcal serogroup C conjugate (MCC) vaccine program in England and Wales.模拟英格兰和威尔士脑膜炎球菌C群结合疫苗(MCC)计划未来的变化。
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Meningococcal polysaccharide-protein conjugate vaccines.脑膜炎球菌多糖-蛋白质结合疫苗
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