12价肺炎球菌结合疫苗在6至10周龄婴儿中的免疫原性和安全性：一项随机双盲活性对照试验。
Immunogenicity and safety of a 12-valent pneumococcal conjugate vaccine in infants aged 6-10 weeks: a randomized double-blind active-controlled trial.
作者信息
Shin Jonghoon, Teeratakulpisarn Jamaree, Puthanakit Thanyawee, Theerawit Tuangtip, Ryu Ji Hwa, Shin Jinhwan, Lee Seulgi, Lee Hayoung, An Kyungjun, Kim Hun
机构信息
SK bioscience, Seonam-si, Republic of Korea.
Department of Pediatrics, Khon Kaen University, Khon Kaen, Thailand.
出版信息
Clin Exp Pediatr. 2020 Jul;63(7):265-271. doi: 10.3345/cep.2019.01067. Epub 2019 Dec 6.
BACKGROUND
Pneumococcal diseases among children aged <5 years worldwide are associated with high annual mortality rates.
PURPOSE
This study aimed to evaluate the immunogenicity and safety of GBP411, a 12-valent pneumococcal conjugant vaccine, with a dosing schedule of 2 primary doses plus 1 booster dose (2p+1) in healthy infants.
METHODS
This randomized active-controlled (Prevnar 13) double-blind phase 2 trial enrolled healthy subjects aged 6-10 weeks. Three serum concentrations of pneumococcal serotype-specific immunoglobulin G (IgG) were evaluated using the pneumococcal serotype-specific pneumonia polysaccharide enzyme-linked immunosorbent assay at 1 month after the primary doses and before and 1 month after the booster dose. The pneumococcal serotype-specific IgG titer was evaluated using a multiplex opsonophagocytic assay in a subset of 15 subjects per group.
RESULTS
After administration of the primary doses, the proportion of subjects who achieved pneumococcal serotype-specific IgG concentrations of >0.35 μg/mL was lower for some serotypes in the GBP411 group than in the comparator group (6B: 20.83% vs. 39.22%, P=0.047 and 19A: 58.33% vs. 90.20%, P<0.001). However, after administration of the booster dose, >97% of the subjects in each group achieved IgG concentrations of ≥0.35 μg/mL for all 12 serotypes. Increased immunogenicity was observed for some serotypes that showed significant intergroup differences after administration of the primary doses but not after the booster dose. We also found no significant intergroup difference in the overall incidence of solicited local adverse events. Furthermore, the overall incidence of solicited systemic adverse events was significantly lower in the GBP411 group than in the comparator vaccine group (79.59% vs. 98.04%; P=0.003).
CONCLUSION
The GBP411 vaccine with a dosing schedule of 2p+1 may be immunogenic and safe for healthy infants.
背景
全球5岁以下儿童的肺炎球菌疾病与较高的年死亡率相关。
目的
本研究旨在评估GBP411（一种12价肺炎球菌结合疫苗）在健康婴儿中采用2剂基础免疫加1剂加强免疫（2p+1）的免疫原性和安全性。
方法
这项随机、活性对照（沛儿13）双盲2期试验纳入了6至10周龄的健康受试者。在基础免疫后1个月、加强免疫前和加强免疫后1个月，使用肺炎球菌血清型特异性肺炎多糖酶联免疫吸附测定法评估三种血清浓度的肺炎球菌血清型特异性免疫球蛋白G（IgG）。在每组15名受试者的亚组中，使用多重调理吞噬测定法评估肺炎球菌血清型特异性IgG滴度。
结果
基础免疫后，GBP411组中某些血清型达到肺炎球菌血清型特异性IgG浓度>0.35μg/mL的受试者比例低于对照疫苗组（6B：20.83%对39.22%，P=0.047；19A：58.33%对90.20%，P<0.001）。然而，加强免疫后，每组>97%的受试者12种血清型的IgG浓度均≥0.35μg/mL。对于一些在基础免疫后显示出显著组间差异但加强免疫后未显示出差异的血清型，观察到免疫原性增加。我们还发现，在主动报告的局部不良事件总体发生率方面，组间无显著差异。此外，GBP411组主动报告的全身不良事件总体发生率显著低于对照疫苗组（79.59%对98.04%；P=0.003）。
结论
采用2p+1免疫程序的GBP411疫苗对健康婴儿可能具有免疫原性且安全。
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