Investigational Vaccine for the Prevention of Disseminated Tuberculosis in HIV Infected People

Summary

A significant number of HIV infected patients in Africa also have disseminated tuberculosis (infection throughout multiple organs). This type of tuberculosis is a significant cause of mortality in these patients. The purpose of this study is to evaluate the safety and effectiveness of a vaccine designed to prevent disseminated tuberculosis.

Timeline

Start

2001-09

Primary completion

2008-12

Completion

2009-05

Publications

• Results Mtei L, Matee M, Herfort O, Bakari M, Horsburgh CR, Waddell R, Cole BF, Vuola JM, Tvaroha S, Kreiswirth B, Pallangyo K, von Reyn CF. High rates of clinical and subclinical tuberculosis among HIV-infected ambulatory subjects in Tanzania. Clin Infect Dis. 2005 May 15;40(10):1500-7. doi: 10.1086/429825. Epub 2005 Apr 12.
• Results von Reyn CF, Mtei L, Arbeit RD, Waddell R, Cole B, Mackenzie T, Matee M, Bakari M, Tvaroha S, Adams LV, Horsburgh CR, Pallangyo K; DarDar Study Group. Prevention of tuberculosis in Bacille Calmette-Guerin-primed, HIV-infected adults boosted with an inactivated whole-cell mycobacterial vaccine. AIDS. 2010 Mar 13;24(5):675-85. doi: 10.1097/QAD.0b013e3283350f1b.
• Results Lahey T, Arbeit RD, Bakari M, Horsburgh CR, Matee M, Waddell R, Mtei L, Vuola JM, Pallangyo K, von Reyn CF. Immunogenicity of a protective whole cell mycobacterial vaccine in HIV-infected adults: a phase III study in Tanzania. Vaccine. 2010 Nov 10;28(48):7652-8. doi: 10.1016/j.vaccine.2010.09.041. Epub 2010 Sep 25.
• Lahey T, Czechura T, Crabtree S, Arbeit RD, Matee M, Horsburgh CR, MacKenzie T, Bakari M, Pallangyo K, von Reyn CF. Greater preexisting interferon gamma responses to mycobacterial antigens and lower bacillary load during HIV-associated tuberculosis. J Infect Dis. 2013 Nov 15;208(10):1629-33. doi: 10.1093/infdis/jit396. Epub 2013 Aug 1.
• Lahey T, Mackenzie T, Arbeit RD, Bakari M, Mtei L, Matee M, Maro I, Horsburgh CR, Pallangyo K, von Reyn CF. Recurrent tuberculosis risk among HIV-infected adults in Tanzania with prior active tuberculosis. Clin Infect Dis. 2013 Jan;56(1):151-8. doi: 10.1093/cid/cis798. Epub 2012 Sep 12.
• Lahey T, Mitchell BK, Arbeit RD, Sheth S, Matee M, Horsburgh CR, MacKenzie T, Mtei L, Bakari M, Vuola JM, Pallangyo K, von Reyn CF. Polyantigenic interferon-gamma responses are associated with protection from TB among HIV-infected adults with childhood BCG immunization. PLoS One. 2011;6(7):e22074. doi: 10.1371/journal.pone.0022074. Epub 2011 Jul 20.
• von Reyn CF, Kimambo S, Mtei L, Arbeit RD, Maro I, Bakari M, Matee M, Lahey T, Adams LV, Black W, Mackenzie T, Lyimo J, Tvaroha S, Waddell R, Kreiswirth B, Horsburgh CR, Pallangyo K. Disseminated tuberculosis in human immunodeficiency virus infection: ineffective immunity, polyclonal disease and high mortality. Int J Tuberc Lung Dis. 2011 Aug;15(8):1087-92. doi: 10.5588/ijtld.10.0517.
• Lahey T, Sheth S, Matee M, Arbeit R, Horsburgh CR, Mtei L, Mackenzie T, Bakari M, Vuola JM, Pallangyo K, von Reyn CF. Interferon gamma responses to mycobacterial antigens protect against subsequent HIV-associated tuberculosis. J Infect Dis. 2010 Oct 15;202(8):1265-72. doi: 10.1086/656332.
• Lahey T, Matee M, Mtei L, Bakari M, Pallangyo K, von Reyn CF. Lymphocyte proliferation to mycobacterial antigens is detectable across a spectrum of HIV-associated tuberculosis. BMC Infect Dis. 2009 Feb 23;9:21. doi: 10.1186/1471-2334-9-21.
• Munseri PJ, Talbot EA, Mtei L, Fordham von Reyn C. Completion of isoniazid preventive therapy among HIV-infected patients in Tanzania. Int J Tuberc Lung Dis. 2008 Sep;12(9):1037-41.

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Indications