tetano
Editor, Senior Moderator
PLoS One
. 2022 Jun 3;17(6):e0268042.
doi: 10.1371/journal.pone.0268042. eCollection 2022.
The safety of co-administration of Bacille Calmette-Guérin (BCG) and influenza vaccines
Paola Villanueva[SUP] 1 2 3 4 [/SUP], Ushma Wadia[SUP] 5 [/SUP], Nigel W Crawford[SUP] 1 2 4 6 [/SUP], Nicole L Messina[SUP] 1 2 [/SUP], Tobias R Kollmann[SUP] 5 [/SUP], Michaela Lucas[SUP] 7 8 9 10 [/SUP], Laurens Manning[SUP] 5 7 11 [/SUP], Peter Richmond[SUP] 5 7 9 [/SUP], Laure F Pittet[SUP] 1 2 3 [/SUP], Nigel Curtis[SUP] 1 2 3 [/SUP]
Affiliations
Abstract
Background: 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.
Methods: 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.
Results: 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.
Conclusions: Adverse events following influenza vaccination are not increased when BCG is co-administered.
. 2022 Jun 3;17(6):e0268042.
doi: 10.1371/journal.pone.0268042. eCollection 2022.
The safety of co-administration of Bacille Calmette-Guérin (BCG) and influenza vaccines
Paola Villanueva[SUP] 1 2 3 4 [/SUP], Ushma Wadia[SUP] 5 [/SUP], Nigel W Crawford[SUP] 1 2 4 6 [/SUP], Nicole L Messina[SUP] 1 2 [/SUP], Tobias R Kollmann[SUP] 5 [/SUP], Michaela Lucas[SUP] 7 8 9 10 [/SUP], Laurens Manning[SUP] 5 7 11 [/SUP], Peter Richmond[SUP] 5 7 9 [/SUP], Laure F Pittet[SUP] 1 2 3 [/SUP], Nigel Curtis[SUP] 1 2 3 [/SUP]
Affiliations
- PMID: 35657850
- DOI: 10.1371/journal.pone.0268042
Abstract
Background: 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.
Methods: 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.
Results: 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.
Conclusions: Adverse events following influenza vaccination are not increased when BCG is co-administered.