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. 2022 Aug 15;3(9):100728. doi: 10.1016/j.xcrm.2022.100728

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© 2022 The Authors

This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

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Cumulative infections and infection severity

(A) Cumulative total infectious diseases during the 15 months of surveillance. This cumulative figure shows all infections per patient, including all COVID-19 events, within the BCG group (blue) compared with the placebo group (red). Included are the infections for which multiple subject events were documented in both BCG and placebo groups. Comparison by means of a Poisson model yields a significant difference with p = 0.004 (BCG n = 24 out of 96 T1D total, placebo n = 20 out of 48 T1D total).

(B) Cumulative infections for two different time periods: pre-COVID-19 pandemic (the 2.5-year period prior to this trial, i.e., the pretrial) and during the COVID-19 pandemic (the current trial period of 15 months). The pretrial time period was when all clinical trial subjects received their ≥3 BCG vaccines or placebo vaccines; the current trial was when the subjects were monitored during the 15-month observation during the COVID-19 pandemic (total patients BCG n = 96, placebo n = 48). The lack of a statistical difference in the number of infections between BCG and placebo groups in the pretrial period suggests that a longer length of time than 2.5 years is necessary to realize BCG’s maximal infectious disease protection. It appears that during the entire period of 15 months, prior BCG vaccinations were protecting from COVID-19 and other infections. ^∗∗p < 0.01.

(C) Infectious disease index for symptomatic patients. Symptomatic patients in the BCG-treated group had significantly reduced total infectious disease symptom index (placebo 152 ± 70 [n = 20] versus BCG 48 ± 11 [n = 31], p = 0.04, single tail and unpaired) as well as average infectious disease symptom index (placebo 23 ± 7 [n = 20] and BCG 13 ± 2 [n = 31], p = 0.04, single tail and unpaired). We first calculated total and average symptom scores per patient and then calculated average and SEM of each of these for BCG and placebo cohorts separately (^∗Student’s t test p < 0.05, one-tailed, unpaired).

(D) Patients in the BCG cohort reported significantly fewer days of missed work during infections compared with the placebo group (^∗p = 0.02). Missed work was reported by 7 out of 32 BCG patients and by 8 out of 17 placebo patients.

(E) The number of patients that reported at least one symptom were 20 out of 48 in the placebo group and 33 out of 96 in the BCG group. The placebo group had more severe average symptoms compared with the BCG group for 12 out of 12 symptoms (left panel). The number of patients in BCG and placebo groups that reported each symptom was then expressed (right panel). For 11 out of 12 symptoms, there was a higher percentage of symptomatic patients in the placebo group compared with the BCG group. Statistical analysis by Student’s t test (one-tailed, unpaired, ^∗p < 0.05).