The safety of co-administration of Bacille Calmette-Guérin (BCG) and influenza vaccines

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 t...

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Bibliographic Details
Published in:PloS one 2022-06, Vol.17 (6), p.e0268042
Main Authors: Villanueva, Paola, Wadia, Ushma, Crawford, Nigel W, Messina, Nicole L, Kollmann, Tobias R, Lucas, Michaela, Manning, Laurens, Richmond, Peter, Pittet, Laure F, Curtis, Nigel
Format: Article
Language:English
Subjects:
Adverse events
BCG
BCG Vaccine - adverse effects
BCG vaccines
Biology and Life Sciences
Coronaviruses
COVID-19 vaccines
Demographics
Dosage and administration
Erythema
Humans
Immunomodulation
Influenza
Influenza vaccines
Influenza Vaccines - adverse effects
Influenza, Human - prevention & control
Medical personnel
Medicine and Health Sciences
Methods
Pain
Patient outcomes
Questionnaires
Research and Analysis Methods
Safety
Statistical analysis
Surveillance
Vaccination
Vaccination - adverse effects
Vaccines
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Summary: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
ISSN:1932-6203
1932-6203
DOI:10.1371/journal.pone.0268042