From the *International Vaccine Access Center, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD; †Biostatistics Consulting, Chicago, IL; ‡Respiratory Diseases Branch, Division of Bacterial Diseases, National Center for Immunizations and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, GA; §Epidemic Intelligence Service, Centers for Disease Control and Prevention, Atlanta, GA; ¶Institute of Child Health, University College London, London, United Kingdom.
Pediatr Infect Dis J. 2014 Jan;33 Suppl 2(Suppl 2 Optimum Dosing of Pneumococcal Conjugate Vaccine For Infants 0 A Landscape Analysis of Evidence Supportin g Different Schedules):S119-29. doi: 10.1097/INF.0000000000000079.
BACKGROUND: Despite the breadth of studies demonstrating benefits of pneumococcal conjugate vaccine (PCV), uncertainty remains regarding the optimal PCV dosing schedule in infants. METHODS: We conducted a systematic literature review of PCV immunogenicity published from 1994 to 2010 (supplemented post hoc with studies from 2011). Studies included for analysis evaluated ≥2 doses of 7-valent or higher product (excluding Aventis-Pasteur PCV11) administered to nonhigh-risk infants ≤6 months of age. Impact of PCV schedule on geometric mean antibody concentration (GMC) and proportion of subjects over 0.35 mcg/mL were assessed at various time points; the GMC 1 month postdose 3 (for various dosing regimens) for serotypes 1, 5, 6B, 14, 19F and 23F was assessed in detail using random effects linear regression, adjusted for product, acellular diphtheria-tetanus-pertussis/whole-cell diphtheria- tetanus-pertussis coadministration, laboratory method, age at first dose and geographic region. RESULTS: From 61 studies, we evaluated 13 two-dose (2+0) and 65 three-dose primary schedules (3+0) without a booster dose, 11 "2+1" (2 primary plus booster) and 42 "3+1" schedules. The GMC after the primary series was higher following 3-dose schedules compared with 2-dose schedules for all serotypes except for serotype 1. Pre- and postbooster GMCs were generally similar regardless of whether 2 or 3 primary doses were given. GMCs were significantly higher for all serotypes when dose 3 was administered in the second year (2+1) compared with ≤6 months of age (3+0). CONCLUSIONS: While giving the third dose in the second year of life produces a higher antibody response than when given as part of the primary series in the first 6 months, the lower GMC between the 2-dose primary series and booster may result in less disease protection for infants in that interval than those who completed the 3-dose primary series. Theoretical advantages of higher antibodies induced by giving the third dose in the second year of life, such as increased protection against serotype 1 disease, longer duration of protection or more rapid induction of herd effects, need to be evaluated in practice.
背景：尽管有大量研究表明肺炎球菌结合疫苗（PCV）具有益处，但在婴儿中最佳的 PCV 接种方案仍存在不确定性。
方法：我们对 1994 年至 2010 年期间发表的 PCV 免疫原性研究进行了系统的文献回顾（事后补充了 2011 年的研究）。进行分析的研究评估了 7 价或更高价产品（不包括 Aventis-Pasteur PCV11）的≥2 剂，用于≤6 个月龄的非高危婴儿。在不同时间点评估了 PCV 方案对几何平均抗体浓度（GMC）和>0.35 mcg/mL 的受试者比例的影响；使用随机效应线性回归详细评估了不同剂量方案（各种剂量方案）下第 3 剂后 1 个月时血清型 1、5、6B、14、19F 和 23F 的 GMC，调整了产品、无细胞白喉-破伤风-百日咳/全细胞白喉-破伤风-百日咳联合接种、实验室方法、首剂年龄和地理位置。
结果：从 61 项研究中，我们评估了 13 项两剂（2+0）和 65 项三剂（3+0）的主要方案，没有加强剂量，11 项“2+1”（2 剂基础加加强）和 42 项“3+1”方案。除血清型 1 外，所有血清型的 3 剂方案的主要系列后 GMC 均高于 2 剂方案。无论给予 2 剂还是 3 剂基础剂量，预加强和加强后的 GMC 通常相似。与 6 个月龄时（3+0）相比，当第 3 剂在第二年（2+1）给予时，所有血清型的 GMC 均显著升高。
结论：虽然在第二年给予第三剂比在 6 个月龄内作为主要系列的一部分给予第三剂产生更高的抗体反应，但在 2 剂基础系列和加强剂之间的较低 GMC 可能会导致该间隔内的婴儿比完成 3 剂基础系列的婴儿获得较少的疾病保护。给予第二年的第三剂所产生的更高抗体的理论优势，例如增加对血清型 1 疾病的保护、延长保护期或更快地诱导群体效应，需要在实践中进行评估。
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