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Multiple BCG vaccinations for the prevention of COVID-19 and other infectious diseases in type 1 diabetes.

ABSTRACT: There is a need for safe and effective platform vaccines to protect against coronavirus disease 2019 (COVID-19) and other infectious diseases. In this randomized, double-blinded, placebo-controlled phase 2/3 trial, we evaluate the safety and efficacy of a multi-dose Bacillus Calmette-Guérin (BCG) vaccine for the prevention of COVID-19 and other infectious disease in a COVID-19-unvaccinated, at-risk-community-based cohort. The at-risk population is made of up of adults with type 1 diabetes. We enrolled 144 subjects and randomized 96 to BCG and 48 to placebo. There were no dropouts over the 15-month trial. A cumulative incidence of 12.5% of placebo-treated and 1% of BCG-treated participants meets criteria for confirmed COVID-19, yielding an efficacy of 92%. The BCG group also displayed fewer infectious disease symptoms and lesser severity and fewer infectious disease events per patient, including COVID-19. There were no BCG-related systemic adverse events. BCG's broad-based infection protection suggests that it may provide platform protection against new severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants and other pathogens.

SUBMITTER: Faustman DL

PROVIDER: S-EPMC9376308 | biostudies-literature | 2022 Sep

REPOSITORIES: biostudies-literature

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Multiple BCG vaccinations for the prevention of COVID-19 and other infectious diseases in type 1 diabetes.

Faustman Denise L DL Lee Amanda A Hostetter Emma R ER Aristarkhova Anna A Ng Nathan C NC Shpilsky Gabriella F GF Tran Lisa L Wolfe Grace G Takahashi Hiroyuki H Dias Hans F HF Braley Joan J Zheng Hui H Schoenfeld David A DA Kühtreiber Willem M WM

Cell reports. Medicine 20220815 9

There is a need for safe and effective platform vaccines to protect against coronavirus disease 2019 (COVID-19) and other infectious diseases. In this randomized, double-blinded, placebo-controlled phase 2/3 trial, we evaluate the safety and efficacy of a multi-dose Bacillus Calmette-Guérin (BCG) vaccine for the prevention of COVID-19 and other infectious disease in a COVID-19-unvaccinated, at-risk-community-based cohort. The at-risk population is made of up of adults with type 1 diabetes. We en ...[more]

PMID: 36027906

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Project description:BackgroundThe global pandemic of coronavirus disease 2019 (COVID-19) has attracted great public health efforts across the world. Few studies, however, have described the potential impact of these measures on other important infectious diseases.MethodsThe incidence of 19 major infectious diseases in Zhejiang Province was collected from the National Notifiable Infectious Disease Surveillance System from January 2017 to October 2020. The entire epidemic control phase was divided into three stages. The government deployed the first level response from 24 January to 2 March (the most rigorous measures). When the outbreak of COVID-19 was under control, the response level changed to the second level from 3 to 23 March, and then the third level response was implemented after 24 March. We compared the epidemiological characteristics of 19 major infectious diseases during different periods of the COVID-19 epidemic and previous years.ResultsA total of 1,814,881 cases of 19 infectious diseases were reported in Zhejiang from January 2017 to October 2020, resulting in an incidence rate of 8088.30 cases per 1,000,000 person-years. After the non-pharmaceutical intervention, the incidence of 19 infectious diseases dropped by 70.84%, from 9436.32 cases per 1,000,000 person-years to 2751.51 cases per 1,000,000 person-years, with the large decrease in the first response period of influenza. However, we observed that the daily incidence of severe fever with thrombocytopenia syndrome (SFTS) and leptospirosis increased slightly (from 1.11 cases per 1,000,000 person-years to 1.82 cases per 1,000,000 person-years for SFTS and 0.30 cases per 1,000,000 person-years to 1.24 cases per 1,000,000 person-years for leptospirosis). There was no significant difference in the distribution of epidemiological characteristic of most infectious diseases before and during the implementation of COVID-19 control measures.ConclusionOur study summarizes the epidemiological characteristics of 19 infectious diseases and indicates that the rigorous control measures for COVID-19 are also effective for majority of infectious diseases.

Project description:BackgroundProtective vaccinations are one of the basic means of infectious disease prevention. The aim of the study was to assess the implementation of compulsory and additional protective vaccinations among adult Poles, their knowledge about the purpose of introducing a vaccination schedule and adverse events following immunization. Opinions about and support for anti-vaccination movements were also examined.Materials and methodsA total of 700 (100%) people aged 18 to 80 (x̅ = 32,16 ± 16,46) took part in the study, conducted using the proprietary questionnaire. All the participants selected randomly from patients of the Department of Cardiology, their visitors, doctors, nurses, paramedics, medical students, and authors' acquaintances gave their informed consent to participate in the study.ResultsAbout 10% of the respondents did not complete the compulsory vaccination schedule. Almost 80% of respondents believed that the main reason for vaccinations schedule occurrence was the desire to completely exclude certain diseases and their complications from the population. More than half of the respondents have never had any additional vaccination. A statistically significant correlation was found between intake of at least one additional vaccination and age (χ2=22.262, p = 0.002) and education level (χ2= 11.074, p = 0.004). Among the respondents, there was a group that classified autism as one of the adverse events following immunization. About 95% of respondents never experienced any adverse events following immunizationand as many as 30 respondents declared their support for anti-vaccination movements.ConclusionThe degree of the implementation of compulsory protective vaccinations in the study group was high, while additional vaccinations were insufficient. The purposefulness of introducing a vaccination schedule was correctly identified by the majority of the respondents, but the knowledge about adverse events following immunisation and their types was incomplete. Among participants were individuals who declared their support for anti-vaccination movements, so society should be constantly educated about vaccinations benefits.

Project description:Aim: The aim of this study was to analyze the changes in incidence of notifiable infectious diseases in China under the prevention and control measures of COVID-19. Methods: Using descriptive epidemiological methods, data were collected from the official website of the Health Commission of the People's Republic of China, and the prevalence characteristics of notifiable infectious diseases in the country in 2020 were analyzed and compared with the historical data in 2019. Monthly reporting data on influenza and tuberculosis from 2015 to 2019 were also collected. Results: Except for COVID-19, the total number of notifiable infectious diseases cases in 2020 was 6,366,176, a decrease of 41.38% year-on-year compared with 2019. Category B and C notifiable infectious diseases decreased by 14.84 and 54.98% year-on-year, respectively (P < 0.01). The top three incidence rates were influenza (87.63 cases/100,000), hepatitis B (81.36 cases/100,000) and other infectious diarrhea (76.33 cases/100,000). Three types of diseases with the largest decline were influenza (-2,280,502 cases), hand-foot-mouth disease (-1,174,588 cases), and other infectious diarrhea diseases (-275,746 cases). Compared with 2019, respiratory infectious diseases were reported to be in the largest decline in 2020, followed by intestinal infectious diseases, blood-borne and sexually transmitted diseases, natural foci, and insect-borne infectious diseases. The monthly reported incidences of influenza and tuberculosis in 2020 were lower than the average of the previous 5 years. Conclusion: In 2020, the incidence of most notifiable infectious diseases in China showed a downward trend, non-pharmaceutical interventions (NPIs)such as the wearing of masks, frequent hand-washing, more ventilation, less gathering, etc, played an positive role in the prevention and control of respiratory and intestinal infectious diseases. The various public health intervention strategies and measures adopted by China to contain COVID-19 can provide a reference for the prevention and control of infectious diseases in other countries.

Dataset Information

Multiple BCG vaccinations for the prevention of COVID-19 and other infectious diseases in type 1 diabetes.

Publications

Multiple BCG vaccinations for the prevention of COVID-19 and other infectious diseases in type 1 diabetes.

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