Xie Zhiqiang, Li Jiangjiao, Wang Xue, Huang Lili, Gou Jinbo, Zhang Wei, Huang Haitao, You Wangyang, Wang Feiyu, Li Xiaolong, Zhang Jinming, Han Qiang, Ma Xiaomin, Wang Yanxia
Henan Province Center for Disease Control and Prevention, Zhengzhou 450003, China.
National Institutes for Food and Drug Control, Beijing 102629, China.
Vaccines (Basel). 2024 Dec 16;12(12):1417. doi: 10.3390/vaccines12121417.
This study aimed to evaluate the immunogenicity and safety of a 13-valent pneumococcal polysaccharide conjugate vaccine (CRM197/TT) (PCV13i) in infants.
A total of 1200 infants were randomly assigned to either the experimental PCV13i group or the control PCV13 group in a 1:1 ratio. Each group received a three-dose series of the vaccine at 2, 4, and 6 months of age, followed by a booster dose at 12-15 months. Blood samples were collected before and 30 days after both primary and booster vaccinations. The primary immunogenicity endpoints were the seropositive rate and the geometric mean concentration (GMC) of IgG antibodies against the 13 pneumococcal serotypes. The primary safety endpoint was the incidence of adverse reactions within 0-7 days and 0-30 days after vaccination.
Results showed that the experimental PCV13i was well tolerated, with a safety profile comparable to that of the control vaccine. Following primary vaccination, the GMCs of IgG responses against serotypes 1, 5, 6A, 6B, 14, and 18C in the experimental group were lower than those in the control group, while responses against serotypes 3, 4, 7F, 9V, 19A, 19F, and 23F were higher. The experimental group exhibited higher opsonophagocytic killing assay (OPA) geometric mean titers (GMTs) for serotypes 3, 7F, 19A, and 19F compared to the control group, while GMTs for serotypes 1, 5, 6A, and 18C were lower. Following booster vaccination, OPA GMTs of the experimental group remained higher than those of the control group for serotypes 3, 7F, and 19F, while GMTs for serotype 5 were lower. Both vaccines induced robust immune responses, with high seropositive rates and significant increases in antibody levels following vaccination.
The experimental PCV13i demonstrated non-inferiority to the control PCV13 in terms of immunogenicity.
本研究旨在评估13价肺炎球菌多糖结合疫苗（CRM197/TT）（PCV13i）在婴儿中的免疫原性和安全性。
总共1200名婴儿以1:1的比例随机分配至实验性PCV13i组或对照PCV13组。每组在2、4和6月龄时接受三剂疫苗接种，随后在12 - 15月龄时进行一剂加强接种。在初次和加强接种前及接种后30天采集血样。主要免疫原性终点为针对13种肺炎球菌血清型的IgG抗体血清阳性率和几何平均浓度（GMC）。主要安全性终点为接种后0 - 7天和0 - 30天内不良反应的发生率。
结果显示，实验性PCV13i耐受性良好，安全性与对照疫苗相当。初次接种后，实验组中针对血清型1、5、6A、6B、14和18C的IgG反应GMC低于对照组，而针对血清型3、4、7F、9V、19A、19F和23F的反应则更高。与对照组相比，实验组中血清型3、7F、19A和19F的调理吞噬杀伤试验（OPA）几何平均滴度（GMT）更高，而血清型1、5、6A和18C的GMT更低。加强接种后，实验组中血清型3、7F和19F的OPA GMT仍高于对照组，而血清型5的GMT更低。两种疫苗均诱导了强烈的免疫反应，接种后血清阳性率高且抗体水平显著升高。
实验性PCV13i在免疫原性方面不劣于对照PCV13。
