Department of Paediatrics, The University of Melbourne, Parkville, VIC, Australia.
Infection and Immunity, Murdoch Children's Research Institute, Parkville, VIC, Australia.
PLoS One. 2022 Jun 3;17(6):e0268042. doi: 10.1371/journal.pone.0268042. eCollection 2022.
With the emergence of novel vaccines and new applications for older vaccines, co-administration is increasingly likely. The immunomodulatory effects of BCG could theoretically alter the reactogenicity of co-administered vaccines. Using active surveillance in a randomised controlled trial, we aimed to determine whether co-administration of BCG vaccination changes the safety profile of influenza vaccination.
Participants who received influenza vaccine alone (Influenza group) were compared with those who also received BCG-Denmark vaccine in the contralateral arm (Influenza+BCG group). Data on the influenza vaccination site were collected using serial questionnaires and active follow-up for 3 months post vaccination.
Of 1351 participants in the Influenza+BCG group and 1418 participants in the Influenza group, 2615 (94%) provided influenza vaccine safety data. There was no significant difference in the proportion of participants with any local adverse reaction between the Influenza+BCG group and the Influenza group (918/1293 [71.0%] versus (906/1322 [68.5%], p = 0.17). The proportion of participants reporting any pain, erythema and tenderness at the influenza vaccination site were similar in both groups. Swelling was less frequent (81/1293 [6.3%] versus 119/1322 (9.0%), p = 0.01) and the maximal diameter of erythema was smaller (mean 1.8 cm [SD 2.0] versus 3.0 cm [SD 2.5], p<0.001) in the Influenza+BCG group. Sixteen participants reported serious adverse events: 9 participants in the Influenza+BCG group and 7 in the Influenza group.
Adverse events following influenza vaccination are not increased when BCG is co-administered.
随着新型疫苗的出现和旧疫苗的新应用，联合接种越来越普遍。卡介苗的免疫调节作用理论上可能改变联合接种疫苗的反应原性。本研究通过在一项随机对照试验中进行主动监测，旨在确定卡介苗接种是否会改变流感疫苗的安全性。
单独接种流感疫苗的参与者（流感组）与接种流感疫苗同侧接种卡介苗-丹麦疫苗的参与者（流感+卡介苗组）进行比较。通过连续的问卷调查和接种后 3 个月的主动随访收集流感疫苗接种部位的数据。
在 1351 名接种流感+卡介苗的参与者和 1418 名接种流感的参与者中，有 2615 名（94%）提供了流感疫苗安全性数据。流感+卡介苗组与流感组任何局部不良反应的参与者比例无显著差异（1293 例中有 918 例（71.0%）比 1322 例中有 906 例（68.5%），p=0.17）。两组报告流感疫苗接种部位任何疼痛、红斑和触痛的参与者比例相似。肿胀的发生率较低（1293 例中有 81 例（6.3%）比 1322 例中有 119 例（9.0%），p=0.01），红斑的最大直径较小（平均 1.8cm[2.0]比 3.0cm[2.5]，p<0.001）在流感+卡介苗组。16 名参与者报告了严重不良事件：流感+卡介苗组 9 例，流感组 7 例。
当联合接种卡介苗时，流感疫苗接种后的不良反应不会增加。
