Pediatric Infectious Disease Unit, Soroka University Medical Center and the Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel.
Clin Infect Dis. 2013 Oct;57(7):952-62. doi: 10.1093/cid/cit428. Epub 2013 Jun 26.
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.
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.
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.
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.
NCT00508742.
13 价肺炎球菌结合疫苗（PCV13）基于血清学非劣效性标准获得许可，用以替代 7 价肺炎球菌结合疫苗（PCV7）。迄今为止，尚无随机 PCV13 儿科试验包含临床终点。
本随机双盲试验比较了 PCV13 与 PCV7 对鼻咽（NP）定植和免疫原性的影响。健康婴儿按 1:1 随机分配至 2、4、6 和 12 月龄时接受 PCV7 或 PCV13 接种；于 2、4、6、7、12、13、18 和 24 月龄采集 NP 拭子，于 7 和 13 月龄采集血液。评估 NP 获得率和流行率以及血清型特异性免疫球蛋白 G（IgG）浓度。
按方案分析人群包括 881 例 PCV13 组和 873 例 PCV7 组。PCV13 显著降低了额外的 PCV13 血清型 1、6A、7F 和 19A、交叉反应血清型 6C 以及常见的 PCV7 血清型 19F 的 NP 获得；对血清型 3 以及其他 PCV7 血清型，疫苗组间无显著差异。血清型 5 的事件太少，无法得出推断。在预定时间点对流行率的影响与 NP 获得观察到的情况相似。PCV13 对 PCV13 附加血清型和血清型 19F 引起的 IgG 反应明显更高，对 6/7 PCV7 血清型引起的反应相似或更低。
PCV13 导致 4 种额外的 PCV13 血清型、血清型 6C 和 19F 的 NP 定植获得率和流行率低于 PCV7，与所有其他常见血清型的 PCV7 相当。这些发现通过直接和间接保护预测了疫苗的有效性。
NCT00508742。
