Therapeutic BCG vaccine protects against long COVID: The BATTLE randomized clinical trial.

Autor: Jalalizadeh M; UroScience, State University of Campinas, Unicamp, Campinas, São Paulo, Brazil., Buosi K; UroScience, State University of Campinas, Unicamp, Campinas, São Paulo, Brazil., Giacomelli CF; UroScience, State University of Campinas, Unicamp, Campinas, São Paulo, Brazil., Leme PAF; UroScience, State University of Campinas, Unicamp, Campinas, São Paulo, Brazil., Ferrari KL; UroScience, State University of Campinas, Unicamp, Campinas, São Paulo, Brazil., Dionato FAV; UroScience, State University of Campinas, Unicamp, Campinas, São Paulo, Brazil., Brito WRS; Laboratory of Virology, Institute of Biological Sciences, Federal University of Pará, Belém, Pará, Brazil., Brunetti NS; Biology Institute, State University of Campinas, Unicamp, Campinas, São Paulo, Brazil., Maia AR; Obesity and Comorbidities Research Center, University of Campinas, Unicamp, Campinas, São Paulo, Brazil., Morari J; Obesity and Comorbidities Research Center, University of Campinas, Unicamp, Campinas, São Paulo, Brazil., Pagliarone AC; UroScience, State University of Campinas, Unicamp, Campinas, São Paulo, Brazil., Farias AS; Biology Institute, State University of Campinas, Unicamp, Campinas, São Paulo, Brazil., Velloso LA; Obesity and Comorbidities Research Center, University of Campinas, Unicamp, Campinas, São Paulo, Brazil., Queiroz MAF; Laboratory of Virology, Institute of Biological Sciences, Federal University of Pará, Belém, Pará, Brazil., Vallinoto ACR; Laboratory of Virology, Institute of Biological Sciences, Federal University of Pará, Belém, Pará, Brazil., Bajgelman MC; Brazilian Biosciences National Laboratory, LNBio, CNPEM, Campinas, São Paulo, Brazil., Reis LO; UroScience, State University of Campinas, Unicamp, Campinas, São Paulo, Brazil.; ImmunOncology, Pontifical Catholic University of Campinas, PUC-Campinas, Campinas, São Paulo, Brazil.
Jazyk: angličtina
Zdroj: Journal of internal medicine [J Intern Med] 2024 Nov 19. Date of Electronic Publication: 2024 Nov 19.
DOI: 10.1111/joim.20033
Abstrakt: Background: Bacillus Calmette-Guérin (BCG) injected during the COVID-19 convalescence period was safe and enhanced recovery from anosmia and dysgeusia in the acute phase.
Objectives: To report the long-term results of the BATTLE trial, BCG vaccine in adults with mild COVID-19.
Methods: Design: Double-blind, placebo-controlled, randomized (1:1) clinical trial.
Intervention: BCG intradermal vaccine and placebo.
Patients: A total of 157 BCG and 142 placebo recipients participated in the 6-month follow-up, and 97 BCG and 95 placebo recipients participated in the 12-month follow-up.
Measurements: Long COVID symptoms and mechanistic analyses.
Results: BCG reduced hearing problems at 6 months (odds ratio [OR] = 0.26) and sleeping, concentration, memory, and vision problems at 12 months (OR = 0.45, 0.36, 0.38, and 0.36, respectively). Sensitivity analyses confirmed that long COVID-19 symptoms were reduced at the 6- and 12-month follow-ups (p = 0.010 and 0.031, respectively). BCG's crossover interaction paradoxically increased hair loss in women and decreased it in men at 6 months (p = 0.032). BCG immunomodulation is likely mediated through inhibition of Fas ligand expression in the blood and increased induction of IL6, IL10, interferon-induced transmembrane protein 3, and angiotensin-converting enzyme 2 in cultured human macrophages.
Conclusion: Long-term follow-up of the BATTLE trial participants revealed that BCG protects against long COVID development if administered within the COVID-19 convalescence period. The response to BCG was subject-specific, including a paradoxical crossover interaction based on sex.
Limitations: Not tested for previous mycobacterial exposure; loss to follow-up, particularly at 12 months.
(© 2024 The Association for the Publication of the Journal of Internal Medicine.)
Databáze: MEDLINE
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