BCG vaccine safety in COVID-19 convalescent adults: BATTLE a randomized controlled trial.
Vaccine
; 40(32): 4603-4608, 2022 07 30.
Article
em En
| MEDLINE
| ID: mdl-35738969
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 11 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.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Tuberculose
/
Vacina BCG
/
COVID-19
Tipo de estudo:
Clinical_trials
Limite:
Adult
/
Humans
Idioma:
En
Revista:
Vaccine
Ano de publicação:
2022
Tipo de documento:
Article
País de afiliação:
Brasil