In a recent study in the New England Journal of Medicine, researchers conducted a randomized controlled trial (RCT) to determine whether Bacille Calmette-Guérin (BCG) vaccines can reduce the burden of coronavirus disease 2019 (COVID-19) on healthcare workers.
BCG vaccines have been known for decades to prevent the target disease, tuberculosis. The vaccine’s “off-target” immunomodulatory effects would likely confer coverage against unrelated infections, adding those caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Previous studies have reported that BCG vaccines may pose the threat of respiratory illness in adolescents and adults and the threat of mortality in newborns.
In this foreign phase 3 RCT, researchers evaluated the effects of the BCG vaccine in reducing the effect of COVID-19 on healthcare workers (BRACE).
The multicenter, double-blind, placebo-controlled trial included health professionals who were randomized in a 1:1 ratio to receive intradermal injections of 0. 10 mL of Bacille Calmette-Guérin-Denmark vaccines (equivalent to 2. 0 to 8. 0 × 105 sets of colony-forming vaccines). Danish strain 1331 of Mycobacterium bovis) or general saline as placebo.
During the one-year follow-up, participants completed questionnaires every three months related to SARS-CoV-2 symptoms and any related illnesses that developed. The number one results of the study were the rates of occurrence of symptomatic and/or severe SARS. CoV-2 infections.
The primary study in the modified intent-to-treat (ITT) population was limited to other people with negative SARS-CoV-2 testing effects at baseline. Secondary outcomes of the study were number of days to onset of COVID-19, episodes of COVID-19, symptomatic duration of COVID-19, duration of bed rest or inability to work, adverse occasions (AEs) and headaches related to COVID-19 and asymptomatic infections.
Complications included pneumonia, hospitalization, ICU admission, mechanical ventilation, supplemental oxygen, and death. Primary and secondary outcomes assessed after six months of randomisation.
All participants provided blood samples at the beginning of the study, three months, six months, nine months, and twelve months after randomization to antibody titers against the SARS-CoV-2 nucleocapsid (N) protein.
In addition, in Brazil, SARS-CoV-2 polymerase chain reaction (PCR) was performed with respiratory swabs received from participants.
The trial took position in two stages: in the initial stage, they were recruited between March 2020 and May 2020 in Australia; in the next stage, they were recruited between May 2020 and April 2021 from Australia, Spain, the Netherlands, Brazil and the United Kingdom (United Kingdom).
The team excluded other people with previous reports of positive SARS-CoV-2 tests; other persons contraindicated for BCG vaccine; other people who earned BCG vaccines in the past year; other people who earned live attenuated vaccines in the past month; others who have won COVID-19 vaccines; and others who have participated in any other COVID-19 prevention trials.
A total of 3988 more people were randomly assigned; recruitment ceased before reaching the first population pattern (7244 individuals) due to the availability of the COVID-19 vaccine.
The modified ITT population included 85% of randomized participants: 1703 and 1683 more people in the vaccinated and placebo groups, respectively. Of the participants, 74% were women and the average age of the participants was 42. 0 years.
At six months, in the modified ITT population, symptomatic SARS-CoV-2 infection occurred in 132 BCG vaccine recipients and 106 who received placebo. % in placebo recipients (threat difference point 2. 40%).
Severe SARS-CoV-2 infection occurred in 75 vaccinated and 61 placebo-infected, with estimates of 7. 60% in those vaccinated with BCG and 6. 50% in those receiving placebo (difference of 1. 10 points).
Most participants who understood the definition of severe SARS-CoV-2 infection were hospitalized but unable to return to work for ≥ 3. 0 consecutive days. Sensitivity research and the effects of further research showed relative differences in risk.
Analyses included only the effects of immediate antigen tests and PCR (no serological data) and analyses that did not account for SARS-CoV-2 express vaccines. The adjusted hazard index (aHR) for any episode of SARS-CoV-2 infection after BCG vaccination compared to placebo 1. 2. Five other people had hospitalizations associated with COVID-19 at each organization (and one placebo recipient died).
In sensitivity research based on immediate antigen testing and the effects of PCR (aHR 1. 4) and research excluding SARS-CoV-2 express vaccines (aHR 1. 2), higher follow-up times produced more accurate estimates, indicating that there were no significant differences in the groups examined. BCG vaccines were intended for administration.
A total of 30. 0 serious adverse events (AEs) were reported, adding 20 in BCG vaccinated. However, apart from a painful abscess at the injection site and lethargy, no severe AEs were associated with BCG vaccination.
The results of the post-hoc research indicated that in older Americans ≥ 60. 0 years, those vaccinated with BCG had fewer symptomatic days than those who received placebo [incidence rate (IR) of 0. 3].
Among Americans with comorbidities, Americans in the BCG organization had fewer symptomatic days than those receiving placebo (IRR 0. 7), while, among Americans with comorbidities, those receiving placebo had fewer days with symptoms (IRR 1. 5).
Regarding the influence of previous BCG vaccines, the effects indicated higher risks of COVID-19 severity in BCG vaccinators than in those receiving placebo in other people with no history of BCG vaccination. BCG vaccines were slightly more likely to spread symptomatic or severe SARS. -CoV-2 infections at six months than those receiving placebo in other people with cardiovascular disease, hypertension or chronic lung disease.
Overall, the effects of the study showed that BCG-Denmark vaccination did not reduce the risk of COVID-19 in HCP versus placebo.
Pittet, L. F. , Messina, N. L. , Orsini, F. , Moore, C. L. , Abruzzo, V. , Barry, S. , Bonnici, R. , Bonten, M. , Campbell, J. , Croda, J. and Dalcolmo, M. . . , 2023. Randomized trial of BCG vaccine against Covid-19 in health workers. New England Journal of Medicine, 388(17), pp. 1582-1596. doi: 10. 1056/NEJMoa2212616 https://www. nejm. org/doi/10. 1056/NEJMoa2212616
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