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在美国新近获批用于≥2 岁人群的四价脑膜炎球菌结合疫苗 MenACWY-TT 的免疫原性和安全性。

Immunogenicity and safety of MenACWY-TT, a quadrivalent meningococcal tetanus toxoid conjugate vaccine recently licensed in the United States for individuals ≥2 years of age.

机构信息

Division of Pediatric Infectious Diseases, Norton Children's and University of Louisville School of Medicine, Louisville, KY, USA.

Department of Pediatrics, Boston University School of Medicine, Boston, MA, USA.

出版信息

Hum Vaccin Immunother. 2022 Nov 30;18(6):2099142. doi: 10.1080/21645515.2022.2099142. Epub 2022 Aug 10.

DOI:10.1080/21645515.2022.2099142
PMID:35947774
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9746432/
Abstract

Vaccination offers the best way to prevent invasive meningococcal disease (IMD). As demonstrated in countries with national immunization programs (NIPs) against IMD, meningococcal conjugate vaccines have contributed to significant declines in incidence. Since some meningococcal vaccines are associated with modest immunogenicity in infants, possible immunological interference upon concomitant administration with some pediatric vaccines, and administration errors resulting from improper reconstitution, opportunities for improvement exist. A quadrivalent conjugate vaccine, MenQuadfi® (Meningococcal [Serogroups A, C, Y, and W] Conjugate Vaccine; Sanofi, Swiftwater, Pennsylvania), was approved in 2020 for the prevention of IMD caused by meningococcal serogroups A, C, W, and Y in individuals ≥2 years of age in the United States. Five pivotal studies and one ancillary study supported approval in the United States; clinical trials in infants are ongoing. Data on the immunogenicity and safety of this vaccine are presented, and its potential value in clinical practice is discussed.

摘要

疫苗接种是预防侵袭性脑膜炎球菌病（IMD）的最佳方法。在有针对 IMD 的国家免疫计划（NIP）的国家中已经证明，脑膜炎球菌结合疫苗有助于发病率的显著下降。由于一些脑膜炎球菌疫苗在婴儿中的免疫原性较低，与某些儿科疫苗同时使用时可能存在免疫干扰，以及由于不正确的复溶导致的给药错误，因此存在改进的机会。一种四价结合疫苗，MenQuadfi®（脑膜炎球菌[血清群 A、C、Y 和 W]结合疫苗；赛诺菲，斯威沃特，宾夕法尼亚州）于 2020 年在美国获得批准，用于预防 2 岁及以上人群由脑膜炎球菌血清群 A、C、W 和 Y 引起的 IMD。五项主要研究和一项辅助研究支持了在美国的批准；婴儿的临床试验正在进行中。本文介绍了该疫苗的免疫原性和安全性数据，并讨论了其在临床实践中的潜在价值。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c858/9746432/7b5e0b6b4eab/KHVI_A_2099142_F0005_B.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c858/9746432/86849ea099c0/KHVI_A_2099142_F0001_OC.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c858/9746432/6e9a5e56bb5f/KHVI_A_2099142_F0002_B.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c858/9746432/ec5950b139ce/KHVI_A_2099142_F0003_B.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c858/9746432/eace9ad24812/KHVI_A_2099142_F0004_B.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c858/9746432/7b5e0b6b4eab/KHVI_A_2099142_F0005_B.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c858/9746432/86849ea099c0/KHVI_A_2099142_F0001_OC.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c858/9746432/6e9a5e56bb5f/KHVI_A_2099142_F0002_B.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c858/9746432/ec5950b139ce/KHVI_A_2099142_F0003_B.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c858/9746432/eace9ad24812/KHVI_A_2099142_F0004_B.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c858/9746432/7b5e0b6b4eab/KHVI_A_2099142_F0005_B.jpg

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本文引用的文献

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Hum Vaccin Immunother. 2023 Dec 31;19(1):2160600. doi: 10.1080/21645515.2022.2160600. Epub 2023 Jan 11.
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Preclinical development of the quadrivalent meningococcal (ACYW) tetanus toxoid conjugate vaccine, MenQuadfi®.脑膜炎球菌（ACYW）四价破伤风类毒素结合疫苗 MenQuadfi®的临床前开发。
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