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Public health
Protocol
Systematic review protocol on Bacillus Calmette-Guerin (BCG) revaccination and protection against tuberculosis
  1. Phetole Walter Mahasha1,
  2. Duduzile Edith Ndwandwe1,
  3. Edison Johannes Mavundza1,
  4. Muki Shey2,
  5. Charles Shey Wiysonge1,3,4
  1. 1 Cochrane South Africa, South African Medical Research Council, Cape Town, South Africa
  2. 2 Wellcome Centre for Infectious Disease Research in Africa (CIDRI-Africa) & Department of Medicine, University of Cape Town, Cape Town, South Africa
  3. 3 Centre for Evidence-based Health Care, Division of Epidemiology and Biostatistics, Department of Global Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa
  4. 4 Division of Epidemiology and Biostatistics, School of Public Health and Family Medicine, University of Cape Town, Cape Town, South Africa
  1. Correspondence to Dr Phetole Walter Mahasha; Phetole.Mahasha{at}mrc.ac.za

Abstract

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

  • Bacille Calmette-Guerin (BCG)
  • Revaccination
  • Tuberculosis

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjopen-2018-027033

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    Footnotes

    • Twitter @@PhetoleMahasha, @CharlesShey

    • Contributors PWM led the development of the protocol, wrote the first draft, coordinated and integrated comments from coauthors, approved the final version for publication and is the guarantor of the manuscript. DEN, EJM and MS critically revised successive drafts of the manuscript, provided important intellectual input and approved the final version of the manuscript. CSW conceived the study, provided supervision and mentorship to PWM, critically revised successive drafts of the manuscript and provided important intellectual input. All authors approved the final version of the manuscript.

    • Funding This review will be supported by the South African Medical Research Council and the National Research Foundation of South Africa (grant number: 106035).

    • Disclaimer The sponsors played no role in the design of the protocol, writing of the report and in the decision to submit the protocol for publication.

    • Competing interests None declared.

    • Patient consent for publication Not required.

    • Ethics approval No formal ethical approval is required for this review, because we will use already published data.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data availability statement There are no data in this work. No data are available.