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MenHibrix:一种用于婴幼儿的新型联合脑膜炎球菌疫苗。

MenHibrix: a new combination meningococcal vaccine for infants and toddlers.

作者信息

Hale Sarah F, Camaione Lauren, Lomaestro Ben M

机构信息

Geisinger Health System, Danville, PA, USA.

出版信息

Ann Pharmacother. 2014 Mar;48(3):404-11. doi: 10.1177/1060028013514375. Epub 2013 Dec 18.

DOI:10.1177/1060028013514375
PMID:24353263
Abstract

OBJECTIVE

To review the immunogenicity and safety of the Haemophilus influenzae type b-Neisseria meningitidis serogroups C and Y tetanus toxoid conjugate vaccine (Hib-MenCY-TT) for infants and toddlers.

DATA SOURCES

Studies conducted in humans and limited to publication in English were identified through a MEDLINE (January 2000 to September 2013) search using the terms Hib-MenCY-TT, MenHibrix, and Haemophilus influenzae type b-Neisseria meningitidis serogroups C and Y tetanus toxoid conjugate vaccine. Clinical trial registries, Web sites, and reference citations from publications identified were reviewed for additional sources.

STUDY SELECTION AND DATA EXTRACTION

Randomized controlled trials were included to evaluate the safety and immunogenicity of Hib-MenCY-TT. Epidemiological data and recommendations from the Advisory Committee on Immunization Practices (ACIP) were also reviewed.

DATA SYNTHESIS

Hib-MenCY-TT is available for primary vaccination of infants as a 4-dose series at 2, 4, 6, and 12 to 15 months of age. Hib-MenCY-TT has comparable immunogenicity to licensed Hib vaccines and produces high levels of N meningitidis antibodies against serogroups C and Y. The most common adverse events were pain and redness at the injection site, drowsiness, and irritability.

CONCLUSIONS

Hib-MenCY-TT has been demonstrated to be a safe and immunogenic vaccination for prevention of disease caused by N meningitidis serogroups C and Y and H influenzae type b in healthy infants and toddlers. Currently, the ACIP recommends the use of Hib-MenCY-TT specifically in high-risk infants aged 6 weeks to 18 months. Hib-MenCY-TT provides the first therapeutic option for vaccination of infants as young as 6 weeks of age who are at increased risk for meningococcal disease.

摘要

目的

回顾b型流感嗜血杆菌- C群和Y群脑膜炎奈瑟菌破伤风类毒素结合疫苗(Hib-MenCY-TT)用于婴幼儿的免疫原性和安全性。

数据来源

通过使用检索词Hib-MenCY-TT、MenHibrix以及b型流感嗜血杆菌- C群和Y群脑膜炎奈瑟菌破伤风类毒素结合疫苗,在MEDLINE(2000年1月至2013年9月)中进行检索,确定在人类中开展且仅限于英文发表的研究。对已识别出版物的临床试验注册库、网站及参考文献进行审查以获取更多来源。

研究选择与数据提取

纳入随机对照试验以评估Hib-MenCY-TT的安全性和免疫原性。还审查了免疫实践咨询委员会(ACIP)的流行病学数据和建议。

数据综合

Hib-MenCY-TT可作为4剂次系列疫苗用于婴儿的基础免疫,接种时间为2、4、6月龄以及12至15月龄。Hib-MenCY-TT的免疫原性与已获许可的Hib疫苗相当,并能产生高水平的针对C群和Y群的脑膜炎奈瑟菌抗体。最常见的不良事件为注射部位疼痛和发红、嗜睡及易激惹。

结论

已证明Hib-MenCY-TT是一种安全且具有免疫原性的疫苗,可预防健康婴幼儿中由C群和Y群脑膜炎奈瑟菌及b型流感嗜血杆菌引起的疾病。目前,ACIP特别推荐在6周龄至18月龄的高危婴儿中使用Hib-MenCY-TT。Hib-MenCY-TT为6周龄的脑膜炎球菌病风险增加的婴儿提供了首个疫苗接种治疗选择。

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