Skip to main content
Top
Published in: Journal of Bioethical Inquiry 2/2009

Open Access 01-06-2009

A New Vaccine for Tuberculosis: The Challenges of Development and Deployment

Authors: Helen A. Fletcher, Tony Hawkridge, Helen McShane

Published in: Journal of Bioethical Inquiry | Issue 2/2009

Login to get access

Abstract

Tuberculosis (TB) is one of the world’s leading causes of death due to infection and efforts to control TB would be substantially aided by the availability of an improved TB vaccine. There are currently nine new TB vaccines in clinical development, and the first efficacy trials are due to commence in 2009. There are many complex ethical issues which arise at all stages of TB vaccine development, from the need to conduct trials in developing countries to informed consent and the process of ethical review. While it is important that these issues are discussed, it may also be timely to consider the challenges which may arise if a vaccine in clinical development proves to be highly effective. We examine a number of scenarios where decisions on the deployment of a new TB vaccine may impact on the rights and liberty of the individual.
Literature
go back to reference Baldwin, S.L., C. D'Souza, A.D. Roberts, B.P. Kelly, A.A. Frank, M.A. Lui, J.B. Ulmer, K. Huygen, D.M. McMurray, and I.M. Orme. 1998. Evaluation of new vaccines in the mouse and guinea pig model of tuberculosis. Infection and Immunity 66(6): 2951–2959.PubMed Baldwin, S.L., C. D'Souza, A.D. Roberts, B.P. Kelly, A.A. Frank, M.A. Lui, J.B. Ulmer, K. Huygen, D.M. McMurray, and I.M. Orme. 1998. Evaluation of new vaccines in the mouse and guinea pig model of tuberculosis. Infection and Immunity 66(6): 2951–2959.PubMed
go back to reference Buchbinder, S.P., D.V. Mehrotra, A. Duerr, D.W. Fitzgerald, R. Mogg, D. Li, P.B. Gilbert, J.R. Lama, M. Marmor, C. Del Rio, M.J. McElrath, D.R. Casimiro, K.M. Gottesdiener, J.A. Chodakewitz, L. Corey, and M.N. Robertson. 2008. Efficacy assessment of a cell-mediated immunity HIV-1 vaccine (the Step Study): A double-blind, randomised, placebo-controlled, test-of-concept trial. Lancet 372(9653): 1881–1893. doi:10.1016/S0140-6736(08)61591-3.PubMedCrossRef Buchbinder, S.P., D.V. Mehrotra, A. Duerr, D.W. Fitzgerald, R. Mogg, D. Li, P.B. Gilbert, J.R. Lama, M. Marmor, C. Del Rio, M.J. McElrath, D.R. Casimiro, K.M. Gottesdiener, J.A. Chodakewitz, L. Corey, and M.N. Robertson. 2008. Efficacy assessment of a cell-mediated immunity HIV-1 vaccine (the Step Study): A double-blind, randomised, placebo-controlled, test-of-concept trial. Lancet 372(9653): 1881–1893. doi:10.​1016/​S0140-6736(08)61591-3.PubMedCrossRef
go back to reference Centers for Disease Control, Prevention (CDC). 2006. Emergence of Mycobacterium tuberculosis with extensive resistance to second-line drugs–worldwide, 2000–2004. MMWR. Morbidity and Mortality Weekly Report 55(11): 301–305. Centers for Disease Control, Prevention (CDC). 2006. Emergence of Mycobacterium tuberculosis with extensive resistance to second-line drugs–worldwide, 2000–2004. MMWR. Morbidity and Mortality Weekly Report 55(11): 301–305.
go back to reference Colditz, G.A., T.F. Brewer, C.S. Berkey, M.E. Wilson, E. Burdick, H.V. Fineberg, and F. Mosteller. 1994. Efficacy of BCG vaccine in the prevention of tuberculosis. Meta-analysis of the published literature. Journal of the American Medical Association 271(9): 698–702. doi:10.1001/jama.271.9.698.PubMedCrossRef Colditz, G.A., T.F. Brewer, C.S. Berkey, M.E. Wilson, E. Burdick, H.V. Fineberg, and F. Mosteller. 1994. Efficacy of BCG vaccine in the prevention of tuberculosis. Meta-analysis of the published literature. Journal of the American Medical Association 271(9): 698–702. doi:10.​1001/​jama.​271.​9.​698.PubMedCrossRef
go back to reference Connelly, D., Y. Veriava, S. Roberts, J. Tsotetsi, A. Jordan, E. DeSilva, S. Rosen, and M.B. DeSilva. 2007. Prevalence of HIV infection and median CD4 counts among health care workers in South Africa. South African Medical Journal 97(2): 115–120.PubMed Connelly, D., Y. Veriava, S. Roberts, J. Tsotetsi, A. Jordan, E. DeSilva, S. Rosen, and M.B. DeSilva. 2007. Prevalence of HIV infection and median CD4 counts among health care workers in South Africa. South African Medical Journal 97(2): 115–120.PubMed
go back to reference Corbett, E.L., C.J. Watt, N. Walker, D. Maher, B.G. Williams, M.C. Raviglione, and C. Dye. 2003. The growing burden of tuberculosis: Global trends and interactions with the HIV epidemic. Archives of Internal Medicine 163(9): 1009–1021. doi:10.1001/archinte.163.9.1009.PubMedCrossRef Corbett, E.L., C.J. Watt, N. Walker, D. Maher, B.G. Williams, M.C. Raviglione, and C. Dye. 2003. The growing burden of tuberculosis: Global trends and interactions with the HIV epidemic. Archives of Internal Medicine 163(9): 1009–1021. doi:10.​1001/​archinte.​163.​9.​1009.PubMedCrossRef
go back to reference Gandhi, N.R., A. Moll, A.W. Sturm, R. Pawinski, T. Govender, U. Lalloo, K. Zeller, J. Andrews, and G. Friedland. 2006. Extensively drug-resistant tuberculosis as a cause of death in patients co-infected with tuberculosis and HIV in a rural area of South Africa. Lancet 368(9547): 1575–1580. doi:10.1016/S0140-6736(06)69573-1.PubMedCrossRef Gandhi, N.R., A. Moll, A.W. Sturm, R. Pawinski, T. Govender, U. Lalloo, K. Zeller, J. Andrews, and G. Friedland. 2006. Extensively drug-resistant tuberculosis as a cause of death in patients co-infected with tuberculosis and HIV in a rural area of South Africa. Lancet 368(9547): 1575–1580. doi:10.​1016/​S0140-6736(06)69573-1.PubMedCrossRef
go back to reference Hanekom, W.A., H.M. Dockrell, T.H. Ottenhoff, T.M. Doherty, H. Fletcher, H. McShane, F.F. Weichold, D.F. Hoft, S.K. Parida, and U.J. Fruth. 2008. Immunological outcomes of new tuberculosis vaccine trials: WHO panel recommendations. PLoS Medicine 5(7): e145. doi:10.1371/journal.pmed.0050145.PubMedCrossRef Hanekom, W.A., H.M. Dockrell, T.H. Ottenhoff, T.M. Doherty, H. Fletcher, H. McShane, F.F. Weichold, D.F. Hoft, S.K. Parida, and U.J. Fruth. 2008. Immunological outcomes of new tuberculosis vaccine trials: WHO panel recommendations. PLoS Medicine 5(7): e145. doi:10.​1371/​journal.​pmed.​0050145.PubMedCrossRef
go back to reference Huygen, K., J. Content, O. Denis, D.L. Montgomery, A.M. Yawman, R.R. Deck, C.M. DeWitt, I.M. Orme, S. Baldwin, C. D'Souza, A. Drowart, E. Lozes, P. Vandenbussche, J.P. Van Vooren, M.A. Liu, and J.B. Ulmer. 1996. Immunogenicity and protective efficacy of a tuberculosis DNA vaccine. Nature Medicine 2(8): 893–898. doi:10.1038/nm0896-893.PubMedCrossRef Huygen, K., J. Content, O. Denis, D.L. Montgomery, A.M. Yawman, R.R. Deck, C.M. DeWitt, I.M. Orme, S. Baldwin, C. D'Souza, A. Drowart, E. Lozes, P. Vandenbussche, J.P. Van Vooren, M.A. Liu, and J.B. Ulmer. 1996. Immunogenicity and protective efficacy of a tuberculosis DNA vaccine. Nature Medicine 2(8): 893–898. doi:10.​1038/​nm0896-893.PubMedCrossRef
go back to reference Ibanga, H.B., R.H. Brookes, P.C. Hill, P.K. Owiafe, H.A. Fletcher, C. Lienhardt, A.V. Hill, R.A. Adegbola, and H. McShane. 2006. Early clinical trials with a new tuberculosis vaccine, MVA85A, in tuberculosis-endemic countries: Issues in study design. The Lancet Infectious Diseases 6(8): 522–528. doi:10.1016/S1473-3099(06)70552-7.PubMedCrossRef Ibanga, H.B., R.H. Brookes, P.C. Hill, P.K. Owiafe, H.A. Fletcher, C. Lienhardt, A.V. Hill, R.A. Adegbola, and H. McShane. 2006. Early clinical trials with a new tuberculosis vaccine, MVA85A, in tuberculosis-endemic countries: Issues in study design. The Lancet Infectious Diseases 6(8): 522–528. doi:10.​1016/​S1473-3099(06)70552-7.PubMedCrossRef
go back to reference Kamath, A.T., U. Fruth, M.J. Brennan, R. Dobbelaer, P. Hubrechts, M.M. Ho, R.E. Mayner, J. Thole, K.B. Walker, M. Liu, and P.H. Lambert. 2005. New live mycobacterial vaccines: The Geneva consensus on essential steps towards clinical development. Vaccine 23(29): 3753–3761. doi:10.1016/j.vaccine.2005.03.001.PubMedCrossRef Kamath, A.T., U. Fruth, M.J. Brennan, R. Dobbelaer, P. Hubrechts, M.M. Ho, R.E. Mayner, J. Thole, K.B. Walker, M. Liu, and P.H. Lambert. 2005. New live mycobacterial vaccines: The Geneva consensus on essential steps towards clinical development. Vaccine 23(29): 3753–3761. doi:10.​1016/​j.​vaccine.​2005.​03.​001.PubMedCrossRef
go back to reference McElrath, M.J., S.C. De Rosa, Z. Moodie, S. Dubey, L. Kierstead, H. Janes, O.D. Defawe, D.K. Carter, J. Hural, R. Akondy, S.P. Buchbinder, M.N. Robertson, D.V. Mehrotra, S.G. Self, L. Corey, J.W. Shiver, and D.R. Casimiro. 2008. HIV-1 vaccine-induced immunity in the test-of-concept Step Study: A case-cohort analysis. Lancet 372(9653): 1894–1905. doi:10.1016/S0140-6736(08)61592-5.PubMedCrossRef McElrath, M.J., S.C. De Rosa, Z. Moodie, S. Dubey, L. Kierstead, H. Janes, O.D. Defawe, D.K. Carter, J. Hural, R. Akondy, S.P. Buchbinder, M.N. Robertson, D.V. Mehrotra, S.G. Self, L. Corey, J.W. Shiver, and D.R. Casimiro. 2008. HIV-1 vaccine-induced immunity in the test-of-concept Step Study: A case-cohort analysis. Lancet 372(9653): 1894–1905. doi:10.​1016/​S0140-6736(08)61592-5.PubMedCrossRef
go back to reference Minnies, D., T. Hawkridge, W. Hanekom, R. Ehrlich, L. London, and G. Hussey. 2008. Evaluation of the quality of informed consent in a vaccine field trial in a developing country setting. BMC Medical Ethics 9: 15. doi:10.1186/1472-6939-9-15.PubMedCrossRef Minnies, D., T. Hawkridge, W. Hanekom, R. Ehrlich, L. London, and G. Hussey. 2008. Evaluation of the quality of informed consent in a vaccine field trial in a developing country setting. BMC Medical Ethics 9: 15. doi:10.​1186/​1472-6939-9-15.PubMedCrossRef
go back to reference Morrison, J., M. Pai, and P.C. Hopewell. 2008. Tuberculosis and latent tuberculosis infection in close contacts of people with pulmonary tuberculosis in low-income and middle-income countries: A systematic review and meta-analysis. The Lancet Infectious Diseases 8(6): 359–368. doi:10.1016/S1473-3099(08)70071-9.PubMedCrossRef Morrison, J., M. Pai, and P.C. Hopewell. 2008. Tuberculosis and latent tuberculosis infection in close contacts of people with pulmonary tuberculosis in low-income and middle-income countries: A systematic review and meta-analysis. The Lancet Infectious Diseases 8(6): 359–368. doi:10.​1016/​S1473-3099(08)70071-9.PubMedCrossRef
go back to reference Selgelid, M.J., P.M. Kelly, and A. Sleigh. 2008a. Ethical challenges in TB control in the era of XDR-TB. The International Journal of Tuberculosis and Lung Disease 12(3): 231–235.PubMed Selgelid, M.J., P.M. Kelly, and A. Sleigh. 2008a. Ethical challenges in TB control in the era of XDR-TB. The International Journal of Tuberculosis and Lung Disease 12(3): 231–235.PubMed
go back to reference Selgelid, M.J., P.M. Kelly, and A. Sleigh. 2008b. In International Public Health Policy and Ethics, ed. M. Boylan. Dordrecht: Springer. Selgelid, M.J., P.M. Kelly, and A. Sleigh. 2008b. In International Public Health Policy and Ethics, ed. M. Boylan. Dordrecht: Springer.
go back to reference Shisana, O., E.J. Hall, R. Maluleke, J. Chauveau, and C. Schwabe. 2004. HIV/AIDS prevalence among South African health workers. South African Medical Journal 94(10): 846–850.PubMed Shisana, O., E.J. Hall, R. Maluleke, J. Chauveau, and C. Schwabe. 2004. HIV/AIDS prevalence among South African health workers. South African Medical Journal 94(10): 846–850.PubMed
go back to reference Williams, A., G.J. Hatch, S.O. Clark, K.E. Gooch, K.A. Hatch, G.A. Hall, K. Huygen, T.H. Ottenhoff, K.L. Franken, P. Andersen, T.M. Doherty, S.H. Kaufmann, L. Grode, P. Seiler, C. Martin, B. Gicquel, S.T. Cole, P. Brodin, A.S. Pym, W. Dalemans, J. Cohen, Y. Lobet, N. Goonetilleke, H. McShane, A. Hill, T. Parish, D. Smith, N.G. Stoker, D.B. Lowrie, G. Kallenius, S. Svenson, A. Pawlowski, K. Blake, and P.D. Marsh. 2005. Evaluation of vaccines in the EU TB Vaccine Cluster using a guinea pig aerosol infection model of tuberculosis. Tuberculosis (Edinburgh, Scotland) 85(1-2): 29–38. doi:10.1016/j.tube.2004.09.009.CrossRef Williams, A., G.J. Hatch, S.O. Clark, K.E. Gooch, K.A. Hatch, G.A. Hall, K. Huygen, T.H. Ottenhoff, K.L. Franken, P. Andersen, T.M. Doherty, S.H. Kaufmann, L. Grode, P. Seiler, C. Martin, B. Gicquel, S.T. Cole, P. Brodin, A.S. Pym, W. Dalemans, J. Cohen, Y. Lobet, N. Goonetilleke, H. McShane, A. Hill, T. Parish, D. Smith, N.G. Stoker, D.B. Lowrie, G. Kallenius, S. Svenson, A. Pawlowski, K. Blake, and P.D. Marsh. 2005. Evaluation of vaccines in the EU TB Vaccine Cluster using a guinea pig aerosol infection model of tuberculosis. Tuberculosis (Edinburgh, Scotland) 85(1-2): 29–38. doi:10.​1016/​j.​tube.​2004.​09.​009.CrossRef
go back to reference World Health Organization. 2007. Global tuberculosis control: surveillance, planning, financing. WHO Report. Geneva: World Health Organisation. World Health Organization. 2007. Global tuberculosis control: surveillance, planning, financing. WHO Report. Geneva: World Health Organisation.
Metadata
Title
A New Vaccine for Tuberculosis: The Challenges of Development and Deployment
Authors
Helen A. Fletcher
Tony Hawkridge
Helen McShane
Publication date
01-06-2009
Publisher
Springer Netherlands
Published in
Journal of Bioethical Inquiry / Issue 2/2009
Print ISSN: 1176-7529
Electronic ISSN: 1872-4353
DOI
https://doi.org/10.1007/s11673-009-9153-6

Other articles of this Issue 2/2009

Journal of Bioethical Inquiry 2/2009 Go to the issue

OriginalPaper

Recent Developments