Immunogenicity and Safety of 13-valent Pneumococcal Conjugate Vaccine in Children Previously Immunized With 7-valent Pneumococcal Conjugate Vaccine
Immunogenicity and Safety of 13-valent Pneumococcal Conjugate Vaccine in Children Previously Immunized With 7-valent Pneumococcal Conjugate Vaccine
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DOI：
10.1097/inf.0b013e3182372c6a
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发表时间：
2011-12-01
影响因子：
3.6
通讯作者：
Gurtman, Alejandra
中科院分区：
文献类型：
--
作者：
Frenck, Robert, Jr.;Thompson, Allison;Gurtman, Alejandra
背景资料：7价肺炎球菌结合疫苗（PCV 7）已被证明在预防肺炎链球菌引起的疾病方面非常有效;然而，在某些地区，血清型覆盖率有限。最近获得许可的13价PCV（PCV 13）被开发出来，以在全球范围内提供额外的覆盖。先前接种过PCV 7疫苗的儿童可以从PCV 13补充疫苗接种中获益，以提供针对PCV 13中另外6种血清型的保护。本研究旨在评价PCV 13对既往接种过PCV 7疫苗的健康儿童的免疫原性和安全性。方法：15月龄至2岁儿童（第1组）接种2剂PCV 13; 2岁至5岁儿童（第2组）接种1剂PCV 13。在接种疫苗前和末次接种后1个月，测量针对PCV 13中多糖抗原的抗体（免疫球蛋白G）。收集疫苗接种后7天的征集性局部和全身不良事件（AE）。结果：共有284例受试者（第1组：n = 109;第2组：n = 175）有血液可供检测。PCV 7血清型抗肺炎球菌免疫球蛋白G几何平均倍数升高范围为2- 19倍，另外6种血清型约为2- 124倍。此外，对于PCV 13种血清型中的12种，两组中>= 98%的受试者的接种后滴度超过0.35 μ g/mL，这是儿童对肺炎球菌免疫的血清学相关性。血清3型疫苗后滴度超过免疫血清学相关值的受试者百分比略低，第1组和第2组分别为94.5%和92%。反应原性通常是温和的，自限性，和非征集性AE报告一般与常见的儿童期疾病一致。结论：PCV 13是安全的，免疫原性的儿童谁以前收到PCV 7，可用于补充精神疫苗接种，以提供额外的保护，对6个额外的血清型。
Background: The 7-valent pneumococcal conjugate vaccine (PCV7) has proven highly effective in preventing diseases caused by Streptococcus pneumoniae; however, in some regions, serotype coverage is limited. A recently licensed 13-valent PCV (PCV13) was developed to provide additional coverage globally. Children previously vaccinated with PCV7 could benefit from supplemental vaccination with PCV13 to provide protection against the 6 additional serotypes in PCV13. This open-label study evaluated the immunogenicity and safety of administering PCV13 to healthy children previously vaccinated with PCV7.Methods: Children between 15 months and 2 years of age (group 1) received 2 doses of PCV13; children between 2 and 5 years (group 2) received 1 dose. Antibodies (immunoglobulin G) against the polysaccharide antigens in PCV13 were measured before vaccination and 1 month after the final dose. Solicited local and systemic adverse events (AEs) were collected for 7 days postvaccination. Unsolicited and serious AEs were collected throughout.Results: A total of 284 subjects (group 1: n = 109; group 2: n = 175) had blood available for testing. Antipneumococcal immunoglobulin G geometric mean fold rises ranged from 2- to 19-fold for the PCV7 serotypes and from approximately 2- to 124-fold for the 6 additional serotypes. Additionally, postvaccination titers in excess of 0.35 mu g/mL, the serologic correlate of immunity against pneumococcus for children, occurred in >= 98% of subjects in both groups for 12 of the 13 serotypes in PCV13. Slightly lower percentage of subjects, 94.5% and 92% of subjects in group 1 and group 2, respectively, had postvaccine titers for serotype 3 exceeding the serologic correlate of immunity. Reactogenicity was typically mild and self-limited, and unsolicited AEs reported were generally consistent with common childhood illnesses.Conclusion: PCV13 was safe and immunogenic when administered to children who had previously received PCV7, and can be used for supple-mental vaccination to provide additional protection against the 6 additional serotypes.