Systematic review protocol on Bacillus Calmette-Guerin (BCG) revaccination and protection against tuberculosis

Introduction Tuberculosis (TB) is a disease caused by Mycobacterium tuberculosis (M.TB) and other species of the Mycobacterium tuberculosis complex. Globally, TB is ranked as the ninth leading cause of death and the leading cause of death from a single infectious agent. The bacille Calmette-Guerin (...

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Main Authors: Duduzile Edith Ndwandwe, Muki Shey, Charles Shey Wiysonge, Phetole Walter Mahasha, Edison Johannes Mavundza
Format: Article
Language:English
Published: BMJ Publishing Group 2019-10-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/9/10/e027033.full
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author Duduzile Edith Ndwandwe
Muki Shey
Charles Shey Wiysonge
Phetole Walter Mahasha
Edison Johannes Mavundza
author_facet Duduzile Edith Ndwandwe
Muki Shey
Charles Shey Wiysonge
Phetole Walter Mahasha
Edison Johannes Mavundza
author_sort Duduzile Edith Ndwandwe
collection DOAJ
description Introduction Tuberculosis (TB) is a disease caused by Mycobacterium tuberculosis (M.TB) and other species of the Mycobacterium tuberculosis complex. Globally, TB is ranked as the ninth leading cause of death and the leading cause of death from a single infectious agent. The bacille Calmette-Guerin (BCG) vaccine has been used globally since 1921 for the prevention of TB in humans, and was derived from an attenuated strain of Mycobacterium bovis. Evidence from previous randomised trials show that the efficacy of primary BCG vaccination against pulmonary TB ranged from no protection to very high protection. In addition, some studies suggest a benefit of BCG revaccination. For example, a recent trial conducted in South Africa showed that BCG revaccination of adolescents could reduce the risk of TB infection by half. However, we are not aware of any recent systematic reviews of the effects of BCG revaccination. Thus, the need for this systematic review of the effects of BCG revaccination on protection against TB infection and disease.Method and analysis We will search PubMed, the Cochrane Central Register of Controlled Trials, EMBASE, WHO International Clinical Trials Registry Platform and reference lists of relevant publications for potentially eligible studies. We will screen search outputs, select eligible studies, extract data and assess risk of bias in duplicate. Discrepancies will be resolved by discussion and consensus or arbitration. We will use the Grading of Recommendations Assessment, Development and Evaluation method to assess the certainty of the evidence. The planned systematic review was registered with the International Prospective Register of Systematic Reviews (PROSPERO) in August 2018.Ethics and dissemination Publicly available data will be used, hence no formal ethical approval will be required for this review. The findings of the review will be disseminated through conference presentations and publication in an open-access peer-reviewed journal.PROSPERO registration number CRD42018105916
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spelling doaj-art-1e505abde40b4740bc3d72e454fce98f2024-12-14T06:40:09ZengBMJ Publishing GroupBMJ Open2044-60552019-10-0191010.1136/bmjopen-2018-027033Systematic review protocol on Bacillus Calmette-Guerin (BCG) revaccination and protection against tuberculosisDuduzile Edith Ndwandwe0Muki Shey1Charles Shey Wiysonge2Phetole Walter Mahasha3Edison Johannes Mavundza4Cochrane South Africa, South African Medical Research Council, Tygerberg, South Africa2 Wellcome Centre for Infectious Disease Research in Africa (CIDRI-Africa) & Department of Medicine, University of Cape Town, Cape Town, South Africa5 School of Public Health and Family Medicine, University of Cape Town, Cape Town, Western Cape, South AfricaGrants, Innovation and Product Development Unit, South African Medical Research Council, Cape Town, South Africa1 Cochrane South Africa, South African Medical Research Council, Cape Town, South AfricaIntroduction Tuberculosis (TB) is a disease caused by Mycobacterium tuberculosis (M.TB) and other species of the Mycobacterium tuberculosis complex. Globally, TB is ranked as the ninth leading cause of death and the leading cause of death from a single infectious agent. The bacille Calmette-Guerin (BCG) vaccine has been used globally since 1921 for the prevention of TB in humans, and was derived from an attenuated strain of Mycobacterium bovis. Evidence from previous randomised trials show that the efficacy of primary BCG vaccination against pulmonary TB ranged from no protection to very high protection. In addition, some studies suggest a benefit of BCG revaccination. For example, a recent trial conducted in South Africa showed that BCG revaccination of adolescents could reduce the risk of TB infection by half. However, we are not aware of any recent systematic reviews of the effects of BCG revaccination. Thus, the need for this systematic review of the effects of BCG revaccination on protection against TB infection and disease.Method and analysis We will search PubMed, the Cochrane Central Register of Controlled Trials, EMBASE, WHO International Clinical Trials Registry Platform and reference lists of relevant publications for potentially eligible studies. We will screen search outputs, select eligible studies, extract data and assess risk of bias in duplicate. Discrepancies will be resolved by discussion and consensus or arbitration. We will use the Grading of Recommendations Assessment, Development and Evaluation method to assess the certainty of the evidence. The planned systematic review was registered with the International Prospective Register of Systematic Reviews (PROSPERO) in August 2018.Ethics and dissemination Publicly available data will be used, hence no formal ethical approval will be required for this review. The findings of the review will be disseminated through conference presentations and publication in an open-access peer-reviewed journal.PROSPERO registration number CRD42018105916https://bmjopen.bmj.com/content/9/10/e027033.full
spellingShingle Duduzile Edith Ndwandwe
Muki Shey
Charles Shey Wiysonge
Phetole Walter Mahasha
Edison Johannes Mavundza
Systematic review protocol on Bacillus Calmette-Guerin (BCG) revaccination and protection against tuberculosis
BMJ Open
title Systematic review protocol on Bacillus Calmette-Guerin (BCG) revaccination and protection against tuberculosis
title_full Systematic review protocol on Bacillus Calmette-Guerin (BCG) revaccination and protection against tuberculosis
title_fullStr Systematic review protocol on Bacillus Calmette-Guerin (BCG) revaccination and protection against tuberculosis
title_full_unstemmed Systematic review protocol on Bacillus Calmette-Guerin (BCG) revaccination and protection against tuberculosis
title_short Systematic review protocol on Bacillus Calmette-Guerin (BCG) revaccination and protection against tuberculosis
title_sort systematic review protocol on bacillus calmette guerin bcg revaccination and protection against tuberculosis
url https://bmjopen.bmj.com/content/9/10/e027033.full
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