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免疫原性与反应原性之间的关联:含佐剂的重组带状疱疹疫苗 2 项 3 期研究的事后分析。

Association Between Immunogenicity and Reactogenicity: A Post Hoc Analysis of 2 Phase 3 Studies With the Adjuvanted Recombinant Zoster Vaccine.

机构信息

GSK, Wavre, Belgium.

GSK, Rockville, Maryland, USA.

出版信息

J Infect Dis. 2022 Nov 28;226(11):1943-1948. doi: 10.1093/infdis/jiab536.

DOI:10.1093/infdis/jiab536
PMID:34662415
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9704432/
Abstract

A recurrent question is whether transient reactions to vaccines translate into better immune responses. Using clinical data from 2 large phase 3 studies of the recombinant zoster vaccine, we observed a small but statistically significant association between the intensity of a frequent side effect (pain) after vaccination and immune responses to vaccination. However, despite the statistical correlation, the impact on the immune response is so small, and the immune response in individuals without pain already sufficient, that pain cannot be a surrogate marker for an appropriate immune response. Reactogenicity cannot be used to predict immunity after vaccination.

摘要

一个反复出现的问题是,疫苗的短暂反应是否会转化为更好的免疫反应。我们使用来自 2 项大型重组带状疱疹疫苗 3 期临床试验的临床数据,观察到接种疫苗后一种常见副作用(疼痛)的强度与疫苗接种后的免疫反应之间存在微小但具有统计学意义的关联。然而,尽管存在统计学相关性,但这种影响非常小,而且没有疼痛的个体的免疫反应已经足够充分,因此疼痛不能作为适当免疫反应的替代标志物。反应原性不能用于预测疫苗接种后的免疫。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ba82/9704432/c6f1679db631/jiab536_fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ba82/9704432/c6f1679db631/jiab536_fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ba82/9704432/c6f1679db631/jiab536_fig1.jpg

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