BCG vaccine safety in COVID-19 convalescent adults: BATTLE a randomized controlled trial

Franciele A V Dionato, Mehrsa Jalalizadeh, Keini Buosi, Marília B Visacri, Luciana S B Dal Col, Cristiane F Giacomelli, Patricia A F Leme, Cristiane L Maia, Patricia Moriel, Leonardo O Reis, Franciele A V Dionato, Mehrsa Jalalizadeh, Keini Buosi, Marília B Visacri, Luciana S B Dal Col, Cristiane F Giacomelli, Patricia A F Leme, Cristiane L Maia, Patricia Moriel, Leonardo O Reis

Abstract

Introduction: The safety of BCG revaccination is uncertain and there is no data on its use in patients with COVID-19.

Methods: COVID-19 convalescent adults confirmed by SARS-CoV-2 RT-PCR in South-America were 1:1 randomized in the first 14 days of symptoms to BCG intradermal vaccine or placebo and evaluated for adverse events on days 7, 14, 21, and beyond 40 days.

Clinical trial registration: NCT04369794.

Results: 151 placebo and 148 BCG patients were included in the final analysis, with an average age of 40.7 years. No severe adverse event to BCG was reported. On day 7, 130 (87.8%) of the BCG recipients had local reaction, average size of 10.6 ± 6.4 mm, compared to only 2 (1.3%) placebos. Lesions gradually shrunk in size (mean 10.5 mm, 9.7 mm, and 6.8 mm at 14, 21, and beyond 40 days, respectively. The number of symptoms in any of the visits was not different between groups, and anosmia resolved earlier (25.7% vs. 37.1% at 7 days, OR = 1.70, 1.01-2.89, p = 0.035) in the BCG recipients.

Conclusion: The BCG revaccination is safe in convalescent COVID-19 adults of a tuberculosis endemic region, regardless of tuberculin or IGRA test results. Local adverse events were similar though occurred earlier to that previously reported in children.

Keywords: BCG Lesion; BCG vaccine; COVID-19; Outcomes; Randomized controlled trial; SARS-CoV-2; Safety.

Conflict of interest statement

Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: [Leonardo O. Reis reports financial support was provided by Coordination of Higher Education Personnel Improvement.].

Copyright © 2022 Elsevier Ltd. All rights reserved.

Figures

Fig. 1
Fig. 1
Study flowchart (BCG = Bacillus Calmette-Guérin; n = number of participants).
Fig. 2
Fig. 2
Number of symptoms on each visit.
Fig. 3
Fig. 3
Sensitivity analysis odds ratio adjusted for chronic pulmonary disease.
Fig. 4
Fig. 4
Average lesion size on each visit.
Supplementary Figure 1
Supplementary Figure 1
Study timeline.
Supplementary Figure 2
Supplementary Figure 2
Vaccine lesion monitoring.

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Source: PubMed

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