Effect of BCG vaccination against Mycobacterium tuberculosis infection in adult Brazilian health-care workers: a nested clinical trial
The effectiveness of BCG vaccine for adult pulmonary tuberculosis remains uncertain. In this study, we aimed to evaluate the effect of vaccination with BCG-Denmark to prevent initial and sustained interferon-γ release assay conversion in Brazilian health-care workers. This substudy is a nested rando...
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| Veröffentlicht in: | The Lancet infectious diseases 2024-06, Vol.24 (6), p.594-601 |
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| creator | dos Santos, Paulo Cesar Pereira Messina, Nicole Louise de Oliveira, Roberto Dias da Silva, Patricia Vieira Puga, Marco Antonio Moreira Dalcolmo, Margareth dos Santos, Glauce de Lacerda, Marcus Vinícius Guimarães Jardim, Bruno Araújo de Almeida e Val, Fernando Fonseca Curtis, Nigel Andrews, Jason R Croda, Julio |
| description | The effectiveness of BCG vaccine for adult pulmonary tuberculosis remains uncertain. In this study, we aimed to evaluate the effect of vaccination with BCG-Denmark to prevent initial and sustained interferon-γ release assay conversion in Brazilian health-care workers.
This substudy is a nested randomised controlled trial embedded within the BRACE trial (NCT04327206). Specifically, this substudy enrolled Brazilian health-care workers (aged ≥18 years) from three sites in Brazil (Manaus, Campo Grande, and Rio de Janeiro) irrespective of previously receiving BCG vaccination. Participants were excluded if they had contraindications to BCG vaccination, more than 1 month of treatment with specific tuberculosis treatment drugs, previous adverse reactions to BCG, recent BCG vaccination, or non-compliance with assigned interventions. Those eligible were randomly assigned (1:1) to either the BCG group (0·1 mL intradermal injection of BCG-Denmark [Danish strain 1331; AJ Vaccines, Copenhagen]) or the placebo group (intradermal injection of 0·9% saline) using a web-based randomisation process in variable-length blocks (2, 4, or 6), and were stratified based on the study site, age ( |
| doi_str_mv | 10.1016/S1473-3099(23)00818-6 |
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This substudy is a nested randomised controlled trial embedded within the BRACE trial (NCT04327206). Specifically, this substudy enrolled Brazilian health-care workers (aged ≥18 years) from three sites in Brazil (Manaus, Campo Grande, and Rio de Janeiro) irrespective of previously receiving BCG vaccination. Participants were excluded if they had contraindications to BCG vaccination, more than 1 month of treatment with specific tuberculosis treatment drugs, previous adverse reactions to BCG, recent BCG vaccination, or non-compliance with assigned interventions. Those eligible were randomly assigned (1:1) to either the BCG group (0·1 mL intradermal injection of BCG-Denmark [Danish strain 1331; AJ Vaccines, Copenhagen]) or the placebo group (intradermal injection of 0·9% saline) using a web-based randomisation process in variable-length blocks (2, 4, or 6), and were stratified based on the study site, age (<40, ≥40 to <60, ≥60 years), and comorbidity presence (diabetes, chronic respiratory disease, cardiac condition, hypertension). Sealed syringes were used to prevent inadvertent disclosure of group assignments. The QuantiFERON-TB Gold (QFT) Plus test (Qiagen; Hilden, Germany) was used for baseline and 12-month tuberculosis infection assessments. The primary efficacy outcome was QFT Plus conversion (≥0·35 IU/mL) by 12 months following vaccination in participants who had a negative baseline result (<0·35 IU/mL).
Between Oct 7, 2020, and April 12, 2021, 1985 (77·3%) of 2568 participants were eligible for QFT Plus assessment at 12 months and were included in this substudy; 996 (50·2%) of 1985 were in the BCG group and 989 (49·8%) were in the placebo group. Overall, 1475 (74·3%) of 1985 participants were women and 510 (25·7%) were men, and the median age was 39 years (IQR 32–47). During the first 12 months, QFT Plus conversion occurred in 66 (3·3%) of 1985 participants, with no significant differences by study site (p=0·897). Specifically, 34 (3·4%) of 996 participants had initial QFT conversion in the BCG group compared with 32 (3·2%) of 989 in the placebo group (risk ratio 1·09 [95% CI 0·67–1·77]; p=0·791).
BCG-Denmark vaccination did not reduce initial QFT Plus conversion risk in Brazilian health-care workers. This finding underscores the need to better understand tuberculosis prevention in populations at high risk.
Bill & Melinda Gates Foundation, the Minderoo Foundation, Sarah and Lachlan Murdoch, the Royal Children's Hospital Foundation, Health Services Union NSW, the Peter Sowerby Foundation, SA Health, the Insurance Advisernet Foundation, the NAB Foundation, the Calvert-Jones Foundation, the Modara Pines Charitable Foundation, the United Health Group Foundation, Epworth Healthcare, and individual donors.
For the Portuguese translation of the abstract see Supplementary Materials section.</description><identifier>ISSN: 1473-3099</identifier><identifier>ISSN: 1474-4457</identifier><identifier>EISSN: 1474-4457</identifier><identifier>DOI: 10.1016/S1473-3099(23)00818-6</identifier><identifier>PMID: 38423021</identifier><language>eng</language><publisher>United States: Elsevier Ltd</publisher><subject>Adult ; Adults ; Age groups ; Antigens ; Bacillus Calmette-Guerin vaccine ; BCG ; BCG Vaccine - administration & dosage ; BCG Vaccine - immunology ; Brazil ; Charities ; Clinical trials ; Comorbidity ; Coronary artery disease ; COVID-19 vaccines ; Data collection ; Diabetes mellitus ; Female ; Health care ; Health Personnel ; Health services ; Heart diseases ; Humans ; Hypertension ; Immunology ; Infections ; Injection ; Interferon ; Interferon-gamma Release Tests ; Male ; Medical personnel ; Middle Aged ; Mycobacterium tuberculosis - immunology ; Placebos ; Prevention ; Randomization ; Respiratory diseases ; Risk ; Syringes ; Teenagers ; Translation ; Tuberculosis ; Tuberculosis, Pulmonary - prevention & control ; Vaccination ; Vaccines ; Workers ; Young Adult ; γ-Interferon</subject><ispartof>The Lancet infectious diseases, 2024-06, Vol.24 (6), p.594-601</ispartof><rights>2024 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license</rights><rights>Copyright © 2024 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.</rights><rights>2024. The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. This work is published under https://creativecommons.org/licenses/by/3.0/ (theLicense”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c440t-c1e02bcfd5c4286316f7e283ef3f5f78d4556217bb0043e383d9808aa2c06cc13</citedby><cites>FETCH-LOGICAL-c440t-c1e02bcfd5c4286316f7e283ef3f5f78d4556217bb0043e383d9808aa2c06cc13</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S1473309923008186$$EHTML$$P50$$Gelsevier$$Hfree_for_read</linktohtml><link.rule.ids>314,776,780,3537,27901,27902,65306</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/38423021$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>dos Santos, Paulo Cesar Pereira</creatorcontrib><creatorcontrib>Messina, Nicole Louise</creatorcontrib><creatorcontrib>de Oliveira, Roberto Dias</creatorcontrib><creatorcontrib>da Silva, Patricia Vieira</creatorcontrib><creatorcontrib>Puga, Marco Antonio Moreira</creatorcontrib><creatorcontrib>Dalcolmo, Margareth</creatorcontrib><creatorcontrib>dos Santos, Glauce</creatorcontrib><creatorcontrib>de Lacerda, Marcus Vinícius Guimarães</creatorcontrib><creatorcontrib>Jardim, Bruno Araújo</creatorcontrib><creatorcontrib>de Almeida e Val, Fernando Fonseca</creatorcontrib><creatorcontrib>Curtis, Nigel</creatorcontrib><creatorcontrib>Andrews, Jason R</creatorcontrib><creatorcontrib>Croda, Julio</creatorcontrib><title>Effect of BCG vaccination against Mycobacterium tuberculosis infection in adult Brazilian health-care workers: a nested clinical trial</title><title>The Lancet infectious diseases</title><addtitle>Lancet Infect Dis</addtitle><description>The effectiveness of BCG vaccine for adult pulmonary tuberculosis remains uncertain. In this study, we aimed to evaluate the effect of vaccination with BCG-Denmark to prevent initial and sustained interferon-γ release assay conversion in Brazilian health-care workers.
This substudy is a nested randomised controlled trial embedded within the BRACE trial (NCT04327206). Specifically, this substudy enrolled Brazilian health-care workers (aged ≥18 years) from three sites in Brazil (Manaus, Campo Grande, and Rio de Janeiro) irrespective of previously receiving BCG vaccination. Participants were excluded if they had contraindications to BCG vaccination, more than 1 month of treatment with specific tuberculosis treatment drugs, previous adverse reactions to BCG, recent BCG vaccination, or non-compliance with assigned interventions. Those eligible were randomly assigned (1:1) to either the BCG group (0·1 mL intradermal injection of BCG-Denmark [Danish strain 1331; AJ Vaccines, Copenhagen]) or the placebo group (intradermal injection of 0·9% saline) using a web-based randomisation process in variable-length blocks (2, 4, or 6), and were stratified based on the study site, age (<40, ≥40 to <60, ≥60 years), and comorbidity presence (diabetes, chronic respiratory disease, cardiac condition, hypertension). Sealed syringes were used to prevent inadvertent disclosure of group assignments. The QuantiFERON-TB Gold (QFT) Plus test (Qiagen; Hilden, Germany) was used for baseline and 12-month tuberculosis infection assessments. The primary efficacy outcome was QFT Plus conversion (≥0·35 IU/mL) by 12 months following vaccination in participants who had a negative baseline result (<0·35 IU/mL).
Between Oct 7, 2020, and April 12, 2021, 1985 (77·3%) of 2568 participants were eligible for QFT Plus assessment at 12 months and were included in this substudy; 996 (50·2%) of 1985 were in the BCG group and 989 (49·8%) were in the placebo group. Overall, 1475 (74·3%) of 1985 participants were women and 510 (25·7%) were men, and the median age was 39 years (IQR 32–47). During the first 12 months, QFT Plus conversion occurred in 66 (3·3%) of 1985 participants, with no significant differences by study site (p=0·897). Specifically, 34 (3·4%) of 996 participants had initial QFT conversion in the BCG group compared with 32 (3·2%) of 989 in the placebo group (risk ratio 1·09 [95% CI 0·67–1·77]; p=0·791).
BCG-Denmark vaccination did not reduce initial QFT Plus conversion risk in Brazilian health-care workers. This finding underscores the need to better understand tuberculosis prevention in populations at high risk.
Bill & Melinda Gates Foundation, the Minderoo Foundation, Sarah and Lachlan Murdoch, the Royal Children's Hospital Foundation, Health Services Union NSW, the Peter Sowerby Foundation, SA Health, the Insurance Advisernet Foundation, the NAB Foundation, the Calvert-Jones Foundation, the Modara Pines Charitable Foundation, the United Health Group Foundation, Epworth Healthcare, and individual donors.
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In this study, we aimed to evaluate the effect of vaccination with BCG-Denmark to prevent initial and sustained interferon-γ release assay conversion in Brazilian health-care workers.
This substudy is a nested randomised controlled trial embedded within the BRACE trial (NCT04327206). Specifically, this substudy enrolled Brazilian health-care workers (aged ≥18 years) from three sites in Brazil (Manaus, Campo Grande, and Rio de Janeiro) irrespective of previously receiving BCG vaccination. Participants were excluded if they had contraindications to BCG vaccination, more than 1 month of treatment with specific tuberculosis treatment drugs, previous adverse reactions to BCG, recent BCG vaccination, or non-compliance with assigned interventions. Those eligible were randomly assigned (1:1) to either the BCG group (0·1 mL intradermal injection of BCG-Denmark [Danish strain 1331; AJ Vaccines, Copenhagen]) or the placebo group (intradermal injection of 0·9% saline) using a web-based randomisation process in variable-length blocks (2, 4, or 6), and were stratified based on the study site, age (<40, ≥40 to <60, ≥60 years), and comorbidity presence (diabetes, chronic respiratory disease, cardiac condition, hypertension). Sealed syringes were used to prevent inadvertent disclosure of group assignments. The QuantiFERON-TB Gold (QFT) Plus test (Qiagen; Hilden, Germany) was used for baseline and 12-month tuberculosis infection assessments. The primary efficacy outcome was QFT Plus conversion (≥0·35 IU/mL) by 12 months following vaccination in participants who had a negative baseline result (<0·35 IU/mL).
Between Oct 7, 2020, and April 12, 2021, 1985 (77·3%) of 2568 participants were eligible for QFT Plus assessment at 12 months and were included in this substudy; 996 (50·2%) of 1985 were in the BCG group and 989 (49·8%) were in the placebo group. Overall, 1475 (74·3%) of 1985 participants were women and 510 (25·7%) were men, and the median age was 39 years (IQR 32–47). During the first 12 months, QFT Plus conversion occurred in 66 (3·3%) of 1985 participants, with no significant differences by study site (p=0·897). Specifically, 34 (3·4%) of 996 participants had initial QFT conversion in the BCG group compared with 32 (3·2%) of 989 in the placebo group (risk ratio 1·09 [95% CI 0·67–1·77]; p=0·791).
BCG-Denmark vaccination did not reduce initial QFT Plus conversion risk in Brazilian health-care workers. This finding underscores the need to better understand tuberculosis prevention in populations at high risk.
Bill & Melinda Gates Foundation, the Minderoo Foundation, Sarah and Lachlan Murdoch, the Royal Children's Hospital Foundation, Health Services Union NSW, the Peter Sowerby Foundation, SA Health, the Insurance Advisernet Foundation, the NAB Foundation, the Calvert-Jones Foundation, the Modara Pines Charitable Foundation, the United Health Group Foundation, Epworth Healthcare, and individual donors.
For the Portuguese translation of the abstract see Supplementary Materials section.</abstract><cop>United States</cop><pub>Elsevier Ltd</pub><pmid>38423021</pmid><doi>10.1016/S1473-3099(23)00818-6</doi><tpages>8</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | The Lancet infectious diseases, 2024-06, Vol.24 (6), p.594-601 |
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| recordid | cdi_proquest_miscellaneous_2934273469 |
| source | MEDLINE; Elsevier ScienceDirect Journals |
| subjects | Adult Adults Age groups Antigens Bacillus Calmette-Guerin vaccine BCG BCG Vaccine - administration & dosage BCG Vaccine - immunology Brazil Charities Clinical trials Comorbidity Coronary artery disease COVID-19 vaccines Data collection Diabetes mellitus Female Health care Health Personnel Health services Heart diseases Humans Hypertension Immunology Infections Injection Interferon Interferon-gamma Release Tests Male Medical personnel Middle Aged Mycobacterium tuberculosis - immunology Placebos Prevention Randomization Respiratory diseases Risk Syringes Teenagers Translation Tuberculosis Tuberculosis, Pulmonary - prevention & control Vaccination Vaccines Workers Young Adult γ-Interferon |
| title | Effect of BCG vaccination against Mycobacterium tuberculosis infection in adult Brazilian health-care workers: a nested clinical trial |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-02-06T15%3A50%3A52IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_cross&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Effect%20of%20BCG%20vaccination%20against%20Mycobacterium%20tuberculosis%20infection%20in%20adult%20Brazilian%20health-care%20workers:%20a%20nested%20clinical%20trial&rft.jtitle=The%20Lancet%20infectious%20diseases&rft.au=dos%20Santos,%20Paulo%20Cesar%20Pereira&rft.date=2024-06&rft.volume=24&rft.issue=6&rft.spage=594&rft.epage=601&rft.pages=594-601&rft.issn=1473-3099&rft.eissn=1474-4457&rft_id=info:doi/10.1016/S1473-3099(23)00818-6&rft_dat=%3Cproquest_cross%3E3058531791%3C/proquest_cross%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=3058531791&rft_id=info:pmid/38423021&rft_els_id=S1473309923008186&rfr_iscdi=true |