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The Immunological Basis for Immunization Series The Immunological Basis for Immunization Series Module 5: Tuberculosis Immunization, Vaccines and Biologicals The Immunological Basis for Immunization Series Module 5: Tuberculosis Immunization, Vaccines and Biologicals WHO Library Cataloguing-in-Publication Data The immunological basis for immunization series: module 5: tuberculosis. (Immunological basis for immunization series ; module 5) 1.Tuberculosis - prevention and control. 2.Tuberculosis -microbiology. 3.Tuberculosis - immunology. 4.BCG vaccine - therapeutic use. 5.BCG Vaccine - adverse effects. 6.Vaccination. I.World Health Organization. II.Series. ISBN 978 92 4 150241 2 (NLM classification: WF 200) © World Health Organization 2011 All rights reserved. Publications of the World Health Organization are available on the WHO web site (www.who.int) or can be purchased from WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel.: +41 22 791 3264; fax: +41 22 791 4857; e-mail: [email protected]). Requests for permission to reproduce or translate WHO publications – whether for sale or for noncommercial distribution – should be addressed to WHO Press through the WHO web site (http://www.who.int/about/licensing/copyright_form/en/index.html). The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. All reasonable precautions have been taken by the World Health Organization to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall the World Health Organization be liable for damages arising from its use. The Department of Immunization, Vaccines and Biologicals thanks the donors whose unspecified financial support has made the production of this document possible. This module was produced for Immunization, Vaccines and Biologicals, WHO, by: Lewellys F. Barker Aeras Global TB Vaccine Foundation, Rockville MD, USA Gregory Hussey University of Cape Town, Cape Town, South Africa Printed in October 2011 Copies of this publication as well as additional materials on immunization, vaccines and biological may be requested from: World Health Organization Department of Immunization, Vaccines and Biologicals CH-1211 Geneva 27, Switzerland • Fax: + 41 22 791 4227 • Email: [email protected] • © World Health Organization 2011 All rights reserved. Publications of the World Health Organization can be obtained from WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel: +41 22 791 3264; fax: +41 22 791 4857; email: [email protected]). Requests for permission to reproduce or translate WHO publications – whether for sale or for noncommercial distribution – should be addressed to WHO Press, at the above address (fax: +41 22 791 4806; email: [email protected]). The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. All reasonable precautions have been taken by the World Health Organization to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall the World Health Organization be liable for damages arising from its use. The named authors alone are responsible for the views expressed in this publication. Printed by the WHO Document Production Services, Geneva, Switzerland ii Contents Abbreviations and acronyms .............................................................................................v Preface .............................................................................................................................. vii 1. TB disease .................................................................................................................1 2. Bacteriology .............................................................................................................3 3. The host response to infection ..............................................................................5 4. Characteristics of BCG vaccines ..........................................................................7 5. Response to vaccination with BCG vaccines .....................................................9 5.1 Route of administration of BCG vaccines ......................................................9 5.2 BCG vaccination scars ....................................................................................10 5.3 Delayed type hypersensitivity reactions and cell-mediated response .........11 5.4 Adverse events .................................................................................................11 5.5 Protective efficacy and duration of immunity ..............................................13 6. Future prospects ..................................................................................................18 References ........................................................................................................................20 iii iv Abbreviations and acronyms AIDS acquired immunodeficiency syndrome BCG bacille Calmette-Guérin (vaccine) CFU colony-forming units CI confidence interval DOTS WHO-recommended directly observed treatment tuberculosis control strategy DTH delayed type hypersensitivity ELISPOT enzyme-linked immunospot assay EPI Expanded Programme on Immunization GACVS Global Advisory Committee on Vaccine Safety (WHO) HIV human immunodeficiency virus HLA human leukocyte antigen IGRA interferon gamma release assay IFN-γ interferon-gamma IL-2 interleukin-2 LTBI latent tuberculosis infection M. Mycobacterium MDR-TB multi drug-resistant tuberculosis MRC Medical Research Council (United Kingdom) Mtb Mycobacterium tuberculosis NRAMP natural resistance associated monocyte protein PBMC peripheral blood mononuclear cells PPD purified protein derivative RD1 deletion region 1 SCID severe combined immunodeficiency v TB tuberculosis TH1/2 T helper cells type 1/2 TNF-α tumour necrosis factor-alpha ToC test-of-concept (trial) TST tuberculin skin test WHO World Health Organization USA United States of America XDR-TB extensively drug-resistant tuberculosis vi Preface This module is part of the series The Immunological Basis for Immunization, which was initially developed in 1993 as a set of eight modules focusing on the vaccines included in the Expanded Programme on Immunization (EPI)1. In addition to a general immunology module, each of the seven other modules covered one of the vaccines recommended as part of the EPI programme — diphtheria, measles, pertussis, polio, tetanus, tuberculosis and yellow fever. The modules have become some of the most widely used documents in the field of immunization. With the development of the Global Immunization Vision and Strategy (GIVS) (2005–2015) (http://www.who.int/vaccines-documents/DocsPDF05/GIVS_Final_ EN.pdf) and the expansion of immunization programmes in general, as well as the large accumulation of new knowledge since 1993, the decision was taken to update and extend this series. The main purpose of the modules — which are published as separate disease/vaccine- specific modules — is to give immunization managers and vaccination professionals a brief and easily-understood overview of the scientific basis of vaccination, and also of the immunological basis for the World Health Organization (WHO) recommendations on vaccine use that, since 1998, have been published in the Vaccine Position Papers (http://www.who.int/immunization/documents/positionpapers_intro/en/index.html). WHO would like to thank all the people who were involved in the development of the initial Immunological Basis for Immunization series, as well as those involved in its updating, and the development of new modules. 1 This programme was established in 1974 with the main aim of providing immunization for children in developing countries. vii viii 1. TB disease Tuberculosis (TB) is a bacterial disease which has been prevalent since ancient times. TB is currently
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