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

Dionato, Franciele A. V.; Shobeiri, S. Abbās; Buosi, Keini; Visacri, Marília Berlofa; Col, Luciana S B Dal; Giacomelli, Cristiane F.; Leme, Patrícia Asfora Falabella; Maia, Cristiane L.; Moriel, Patrícia; Reis, Leonardo Oliveira

doi:10.1016/j.vaccine.2022.06.039

Cited by 7 publications

(5 citation statements)

References 10 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Studies on animal models have also been performed which may provide physiologic evidence for the perceived protective effect [48]. Recently completed randomized controlled trials are now attesting to the protective effect of BCG, supporting the findings of this study [49][50][51]. In contrast, some early clinical trials show no effect of BCG vaccination on COVID-19 infection [52,53].…”

Section: Significance Of the Findingssupporting

confidence: 77%

Effectiveness of Bacille Calmette-Guerin vaccination policies in reducing infection and mortality of COVID-19: a systematic review

Obnial

Suzuki²,

Escuadra³

et al. 2022

glob health res policy

View full text Add to dashboard Cite

Background COVID-19 vaccination has been advocated as the most effective way to curb the pandemic. But with its inequitable distribution and slow rollout, especially in low- to middle- income countries, it will still take a long time before herd immunity is achieved. Alternative measures must therefore be explored to bolster current COVID-19 vaccination efforts. In particular, the Bacille Calmette-Guerin vaccine has been studied extensively as to its proposed conferment of non-specific immunity against different infections, including COVID-19. The aim of this study, therefore, is to evaluate the current evidence on the effectiveness of national BCG vaccination policies in reducing infection and mortality of COVID-19. Methods A systematic review was conducted between April to August 2021 following the Preferred Reporting Items for Systematic Reviews and Meta-analysis (PRISMA-P) guidelines. Literature was retrieved from PubMed, Cochrane, HERDIN, Web of Science, EBSCO, and Western Pacific Region Index Medicus (WPRIM). Studies conducted from January 2020 to August 2021 that fell within Level 1A to 2C of the Oxford Center for Evidence-Based Medicine were included in the review. Quality assessment was performed using the appropriate Joanna Briggs Institute critical appraisal tool and a quality assessment checklist for ecological studies adapted from Betran et al. Results A total of 13 studies were included in this review. Nine studies reported significant association between BCG vaccination policies and COVID-19 outcomes, even when controlling for confounding variables. In addition, among other mandated vaccines, such as pneumococcal, influenza, diphtheria-tetanus-pertussis, and measles, only BCG vaccination showed significant association with decreased COVID-19 adverse outcomes. However, other factors also showed positive association with COVID-19 outcomes, particularly markers of high economic status of countries, higher median age, and greater population densities. Conclusion The lower incidence and mortality of COVID-19 in countries with mandated BCG vaccination may not solely be attributable to BCG vaccination policies, but there is still some evidence that demonstrates a possible protective effect. Clinical trials must be continued before recommendations of BCG vaccinations are to be used as an alternative or booster vaccine against COVID-19.

show abstract

Section: Significance Of the Findingssupporting

confidence: 77%

Effectiveness of Bacille Calmette-Guerin vaccination policies in reducing infection and mortality of COVID-19: a systematic review

Obnial

Suzuki²,

Escuadra³

et al. 2022

glob health res policy

View full text Add to dashboard Cite

show abstract

“…The article by Jalalizadeh et al 10 concluded that BCG does not worsen COVID-19 symptoms, including respiratory symptoms. The results of Dionato et al, 31 however, show possible worsening of dyspnea during the second week in the BCG arm. The findings of the second article are further modified by sensitivity analysis, showing that the higher prevalence of dyspnea could have been due to a higher prevalence of chronic pulmonary disease in the BCG arm (failed randomization).…”

Section: Discussionmentioning

confidence: 84%

“…A small lesion at the injection site was reported in the majority of BCG recipients. Dionato et al 31 described the lesions in detail. Only one study found evidence of BCG’s protective effect against respiratory complications: the BRIC trial by Sinha et al 30 assessed the possibility of respiratory failure as the secondary aim of their study by following up their participants for 1, 3, 6, and 9 months, observing for the incidence of COVID-19 complicated with high respiratory rate (>30 breaths/min), low oxygen saturation (<90% on room air), severe respiratory distress, or a diagnosis of acute respiratory distress syndrome (ARDS).…”

Section: Discussionmentioning

confidence: 99%

Effect of BCG on Respiratory Complications Caused by COVID-19: A Scoping Review

Costa¹,

Shobeiri²,

Yadollahvandmiandoab³

et al. 2022

IJGM

Self Cite

View full text Add to dashboard Cite

Bacillus Calmette-Guérin (BCG) has been shown to have protective effects against respiratory viruses. We conducted a scoping review of the literature to clarify the available evidence regarding the effect of BCG therapy in preventing respiratory complications of coronavirus disease 2019 . Methods: We searched PubMed, Embase, CENTRAL, Scopus, and Web of Science for related studies up to October 2022. Results: In total, 35 publications and trials were included. One animal study, two observational studies, and six finalized trials measured the effect of BCG administration on respiratory complications of COVID-19. The remaining publications included eight unfinished trials, 12 ecological studies, and six observational studies that did not directly measure respiratory complications but assessed overall mortality of the disease and were included as an adjunct to our study. All trials involved vaccinating adults to protect them against severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection, and measured respiratory symptoms or the need for intensive respiratory support as the primary or secondary aim of the study. One trial that exclusively included at-risk adults between 18 and 60 years old showed a decreased chance of respiratory complications as the secondary outcome of the study. Another trial that exclusively evaluated this effect on the elderly (60 years and older) as the primary aim of the study reported no protective effect against respiratory complications. The remaining literature provided mostly inconclusive evidence. Conclusion:The majority of the literature on the protective effect of BCG against respiratory complications of COVID-19 is inconclusive.

show abstract

“…However, these data do not correlate with ours due to the different participant profiles and the nature of the study. In a similar study, Dionato et al [ 24 ] assessed the safety of BCG revaccination in patients in recovery from COVID-19, finding no adverse effects, and additionally showing a faster return of the sense of smell in the vaccinated group.…”

Section: Discussionmentioning

confidence: 99%

A Multi-Centre, Randomised, Double-Blind, Placebo-Controlled Phase III Clinical Trial Evaluating the Impact of BCG Re-Vaccination on the Incidence and Severity of SARS-CoV-2 Infections among Symptomatic Healthcare Professionals during the COVID-19 Pandemic in Poland—Evaluation of Antibody Concentrations

Zapolnik

Kmiecik²,

Nowakowska

et al. 2022

Vaccines

View full text Add to dashboard Cite

Tuberculosis (TB) was the predominant cause of death from a single infectious agent worldwide before the severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) pandemic. Although TB vaccines have been successfully used for about 100 years, their full effect is still unknown. In previous studies, a reduced incidence and mortality from a coronavirus disease in TB-vaccinated populations were reported. In this article, we present the secondary analysis of a randomised controlled trial, reporting the results of a serological assessment evaluating the effect of the Bacillus Calmette–Guérin (BCG) vaccine on SARS-CoV-2. Participants—healthcare workers—were assessed 1–2 and 8 months after the second dose of the coronavirus disease 2019 (COVID-19) vaccine. We found no associations between antibody concentration, BCG revaccination, and additional characteristics, such as age, gender, or Body Mass Index. The effect of BCG vaccination on the immunological response against SARS-CoV-2 requires further research.

show abstract

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

Cited by 7 publications

References 10 publications

Effectiveness of Bacille Calmette-Guerin vaccination policies in reducing infection and mortality of COVID-19: a systematic review

Effectiveness of Bacille Calmette-Guerin vaccination policies in reducing infection and mortality of COVID-19: a systematic review

Effect of BCG on Respiratory Complications Caused by COVID-19: A Scoping Review

Contact Info

Product

Resources

About