Zhao Yuliang, Li Guohua, Xia Shengli, Ye Qiang, Yuan Lin, Li Hong, Li Jiangjiao, Chen Jingjing, Yang Shuyuan, Jiang Zhiwei, Zhao Guoqing, Li Rongcheng, Li Yanping, Xia Jielai, Huang Zhen
Hebei Province Centre for Disease Control and Prevention (Hebei CDC), Shijiazhuang, China.
Shanxi Province Centre for Disease Control and Prevention (Shanxi CDC), Taiyuan, China.
Front Microbiol. 2022 May 9;13:870973. doi: 10.3389/fmicb.2022.870973. eCollection 2022.
To determine the non-inferiority of the seven common serotypes (4, 6B, 9V, 14, 18C, 19F, and 23F) in the 13-valent pneumococcal conjugate vaccine (PCV13) with each serotype conjugated to a tetanus toxoid carrier protein and adsorbed on aluminum phosphate and the superiority of its six additional serotypes (1, 3, 5, 6A, 7F, and 19A) to the serotypes in the PCV7.
Participants were evenly randomized in a 1:1 ratio into either the PCV13 or PCV7 groups, to receive three doses of the vaccine at the age of 3, 4, and 5 months, respectively, and a booster dose between 12 and 15 months of age. Serotype-specific antibodies were measured using a standardized enzyme-linked immunosorbent assay (ELISA) and opsonophagocytic activity (OPA) microcolony assay method.
A total of 1,040 healthy infants were enrolled. All the seven common serotypes in the PCV13 were non-inferior to those in the PCV7 in terms of the serotype-specific IgG production induced; however, non-inferiority was not shown for serotype 6B after the infant series. The proportion of subjects who reached OPA antibody titers ≥ 1:8 in the PCV13 group was 89.25% or higher. Local reactions and systemic events were mild or moderate in severity and similar between the two groups. No new safety signals were observed.
The newly developed PCV13 was immunogenic for all serotypes and had a comparable safety profile to the marketed PCV7.
确定13价肺炎球菌结合疫苗（PCV13）中七种常见血清型（4、6B、9V、14、18C、19F和23F）与破伤风类毒素载体蛋白结合并吸附于磷酸铝上时，各血清型的非劣效性，以及其另外六种血清型（1、3、5、6A、7F和19A）相对于PCV7中血清型的优越性。
参与者按1:1比例随机均分为PCV13组或PCV7组，分别在3、4和5月龄时接种三剂疫苗，并在12至15月龄时接种一剂加强疫苗。使用标准化酶联免疫吸附测定（ELISA）和吞噬细胞杀菌活性（OPA）微菌落测定法测量血清型特异性抗体。
共纳入1040名健康婴儿。PCV13中的所有七种常见血清型在诱导的血清型特异性IgG产生方面均不劣于PCV7中的血清型；然而，婴儿系列接种后6B血清型未显示非劣效性。PCV13组中OPA抗体滴度≥1:8的受试者比例为89.25%或更高。局部反应和全身反应的严重程度为轻度或中度，两组相似。未观察到新的安全信号。
新开发的PCV13对所有血清型均具有免疫原性，并且安全性与已上市的PCV7相当。
