Comparative Immunogenicity and Efficacy of 13-Valent and 7-Valent Pneumococcal Conjugate Vaccines in Reducing Nasopharyngeal Colonization: A Randomized Double-Blind Trial
Comparative Immunogenicity and Efficacy of 13-Valent and 7-Valent Pneumococcal Conjugate Vaccines in Reducing Nasopharyngeal Colonization: A Randomized Double-Blind Trial
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DOI：
10.1093/cid/cit428
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发表时间：
2013-10-10
影响因子：
11.8
通讯作者：
Scott, Daniel A.
中科院分区：
文献类型：
--
作者：
Dagan, Ron;Patterson, Scott;Scott, Daniel A.
背景资料。根据血清学非劣势标准，13价肺炎球菌结合疫苗(PCV13)被批准取代7价肺炎球菌结合疫苗(PCV7)。到目前为止，还没有一项随机PCV13儿科试验纳入临床终点。这项随机双盲试验比较了PCV13和PCV7对鼻咽(NP)定植和免疫原性的影响。健康婴儿随机(1：1)在2、4、6和12个月时接受PCV7或PCV13；在2、4、6、7、12、13、18和24个月时采集NP拭子，并在7和13个月时抽血。检测NP的获得率、患病率和血清特异性免疫球蛋白G(Ig G)浓度。按方案分析的人群包括881名PCV13和873名PCV7接受者。PCV13显著减少了额外的PCV13血清型1、6A、7F和19A；交叉反应的血清型6C；以及常见的PCV7血清型19F的NP获得。对于血清3型和其他PCV7血清型，疫苗组之间没有显著差异。血清型5型事件太少，无法得出结论。在预定时间点对患病率的影响与观察到的NP习得的影响相似。PCV13对PCV13的其他血清型和19F型的免疫球蛋白应答显著升高，而对6/7的PCV7血清型的免疫应答相似或较低。与PCV7相比，PCV13对另外4个PCV13血清型以及6C和19F型的NP的获得率和定植流行率更低。在所有其他常见的血清型上，它与PCV7相似。这些发现通过直接和间接保护来预测疫苗的有效性。
Background. The 13-valent pneumococcal conjugate vaccine (PCV13) was licensed to replace the 7-valent pneumococcal conjugate vaccine (PCV7) based on serological noninferiority criteria. To date no randomized PCV13 pediatric trial has included clinical endpoints.Methods. This randomized double-blind trial compared the impact of PCV13 versus PCV7 on nasopharyngeal (NP) colonization and immunogenicity. Healthy infants were randomized (1: 1) to receive PCV7 or PCV13 at ages 2, 4, 6, and 12 months; NP swabs were collected at 2, 4, 6, 7, 12, 13, 18, and 24 months, and blood was drawn at 7 and 13 months. Rates of NP acquisition and prevalence, and serotype-specific immunoglobulin G (IgG) concentrations were assessed.Results. The per protocol analysis population included 881 PCV13 and 873 PCV7 recipients. PCV13 significantly reduced NP acquisition of the additional PCV13 serotypes 1, 6A, 7F, and 19A; the cross-reacting serotype 6C; and the common PCV7 serotype 19F. For serotype 3, and the other PCV7 serotypes, there were no significant differences between the vaccine groups. There were too few serotype 5 events to draw inference. The impact on prevalence at predefined time points was similar to that observed with NP acquisition. PCV13 elicited significantly higher IgG responses for PCV13 additional serotypes and serotype 19F, and similar or lower responses for 6/7 PCV7 serotypes.Conclusions. PCV13 resulted in lower acquisition and prevalence of NP colonization than PCV7 did for 4 additional PCV13 serotypes, and serotypes 6C and 19F. It was comparable with PCV7 for all other common serotypes. These findings predict vaccine effectiveness through both direct and indirect protection.