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18 至 49 岁成年人中 13 价和 15 价肺炎球菌多糖结合疫苗的免疫原性比较。

Comparison of pneumococcal immunogenicity elicited by the PCV13 and PCV15 vaccines in adults 18 through 49 years of age.

机构信息

Vaccine Research & Development, Pfizer Inc., Pearl River, NY 10965, USA.

Vaccine Research & Development, Pfizer Inc., Pearl River, NY 10965, USA.

出版信息

Vaccine. 2023 Oct 26;41(45):6625-6629. doi: 10.1016/j.vaccine.2023.09.043. Epub 2023 Oct 3.

DOI:10.1016/j.vaccine.2023.09.043
PMID:37793976
Abstract

AIM

Pneumococcal conjugate vaccines (PCV13, PCV15, PCV20) effectively target the capsular polysaccharides of the most common disease-causing Streptococcus pneumoniae serotypes. In this short communication, we analyzed healthy participants who received PCV13 and PCV15 vaccines as part of a recently concluded exploratory clinical trial and report antibody responses to the 13 shared serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) as well as functional OPA responses to serotype 3.

METHODS

Sera from 87 adult participants (18 through 49 years of age) randomized to receive either PCV13 or PCV15 were collected (n = 46 or n = 41, respectively), from 17 study centers in the US. IgG concentrations of the 13 shared serotypes and serotype 3-specific OPA titers were analyzed before and 1 month after vaccination using internally validated assays.

RESULTS

At 1 month after vaccination, IgG GMCs of the 13 shared serotypes in PCV13 were similar to those for PCV15. Specifically, serotype 3 OPA GMTs and 95% CIs were similar 1 month after vaccination for PCV13 (62.9 [48.9, 80.9]) and PCV15 (71.1 [50.9, 99.2]).

CONCLUSION

In healthy participants who received either PCV13 or PCV15, similar serotype-specific responses were observed between all shared serotypes when a uniform validated internal assay was used. Of note, data from this study suggest that both vaccines induce similar functional antibody responses against pneumococcal serotype 3.

摘要

目的

肺炎球菌结合疫苗(PCV13、PCV15、PCV20)可有效针对最常见致病肺炎链球菌血清型的荚膜多糖。在本次简短交流中,我们分析了作为最近结束的探索性临床试验的一部分接受 PCV13 和 PCV15 疫苗的健康参与者,并报告了对 13 种共有血清型(1、3、4、5、6A、6B、7F、9V、14、18C、19A、19F 和 23F)的抗体反应,以及对血清型 3 的功能性 OPA 反应。

方法

从美国 17 个研究中心招募的 87 名 18 至 49 岁的成年参与者(分别随机分配接受 PCV13 或 PCV15,n=46 或 n=41),收集接种前和接种后 1 个月的血清。使用内部验证检测,分析 13 种共有血清型和血清型 3 特异性 OPA 滴度的 IgG 浓度。

结果

接种后 1 个月,PCV13 中 13 种共有血清型的 IgG GMC 与 PCV15 相似。具体而言,接种后 1 个月,PCV13(62.9[48.9,80.9])和 PCV15(71.1[50.9,99.2])的血清型 3 OPA GMT 和 95%CI 相似。

结论

在接受 PCV13 或 PCV15 的健康参与者中,当使用统一的内部验证检测时,所有共有血清型之间观察到相似的血清型特异性反应。值得注意的是,这项研究的数据表明,两种疫苗均可诱导针对肺炎球菌血清型 3 的相似功能性抗体反应。

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