Department of Social and Preventive Medicine, Laval University, Quebec City, Canada.
Vaccine. 2012 Oct 5;30(45):6416-20. doi: 10.1016/j.vaccine.2012.08.017. Epub 2012 Aug 21.
The 10-valent protein D pneumococcal conjugate vaccine (PHiD-CV) was licensed on the basis of immunogenicity studies and there are no published data on its effectiveness to prevent invasive pneumococcal disease (IPD). In the province of Quebec, Canada, PHiD-CV was introduced in the summer of 2009, replacing the 7-valent CRM197 vaccine (PCV-7). Transition to the new vaccine was recommended regardless of the number of PCV7 doses already administered.
IPD rates in children born in 2007-2010 and observed up to the end of 2010 were computed from laboratory surveillance data. The main vaccine used for the infant primary immunization series (mainly 2 doses at 2-4 months) and the toddler (12 months) booster dose was inferred from the Quebec City Immunization Registry data.
IPD rates were significantly lower in the cohorts exposed to PHiD-CV (35/100,000 person-years) as compared with those exposed to PCV-7 (64/100,000 person-years; p=0.03). There was no breakthrough vaccine-type IPD case among children who had received ≥2 PHiD-CV doses for the primary series or a single PHiD-CV dose as a booster. There was also a statistically non-significant lower frequency of 19A and other non-vaccine types IPD cases in children exposed to 2+1 PHiD-CV doses as compared with those exposed to PCV-7.
Results are compatible with a high level of protection induced by PHiD-CV against IPD caused by homologous serotypes.
10 价蛋白 D 型肺炎球菌结合疫苗（PHiD-CV）基于免疫原性研究获得许可，尚无关于其预防侵袭性肺炎球菌病（IPD）的有效性的已发表数据。在加拿大魁北克省，PHiD-CV 于 2009 年夏季推出，取代了 7 价 CRM197 疫苗（PCV-7）。无论已接种 PCV7 剂量数如何，均建议向新疫苗过渡。
从实验室监测数据中计算了 2007-2010 年出生并观察至 2010 年底的儿童的 IPD 发生率。婴幼儿（主要是 2-4 个月时接种 2 剂）和幼儿（12 个月）加强剂量的主要疫苗是从魁北克市免疫登记处的数据推断出来的。
与暴露于 PCV-7 的队列相比（35/100,000人年），暴露于 PHiD-CV 的队列的 IPD 发生率明显更低（64/100,000人年；p=0.03）。对于已接受≥2 剂 PHiD-CV 进行基础系列接种或单剂 PHiD-CV 作为加强剂的儿童，未发生突破性疫苗型 IPD 病例。与暴露于 PCV-7 的儿童相比，暴露于 2+1 PHiD-CV 剂量的儿童中，19A 和其他非疫苗型 IPD 病例的频率也略有统计学意义降低。
结果与 PHiD-CV 针对同源血清型 IPD 引起的高保护水平一致。
