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Appendix B: Report from the National Institute of Allergy and Infectious Diseases (NIAID) Workshop
Pages 103-108

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From page 103...
... • The same epidemiological model cannot be used for TB and HIV epidemics in different countries. 1 This Appendix B summarizes the presentation made by Valerie Mizrahi of the National Health Laboratory Service and University of Witwatersrand and Barbara Laughon of the National Institutes of Health.
From page 104...
... • A TB control program must be able to rapidly identify cases and commence therapy. • Operational research and implementation science are needed to enhance feasible and available infection control strategies and sup port the development and testing of new approaches.
From page 105...
... • Key questions beyond the performance characteristics of a new diagnostic involve delivery, roll-out, and scale-up, as well as the impact on patient outcomes, program performance, the burden of disease, and global TB control. • The experience of the National Health Laboratory Service in mov ing from validation of new technology to roll-out of the LPA was illuminating.
From page 106...
... • There is a huge R&D funding gap. More funds are needed to facili tate preclinical development, to build capacity at trial sites, to per form clinical trials, and to provide enabling infrastructure.
From page 107...
... • In terms of clinical preparedness for new vaccines, challenges include -- costs, site development, a lack of immunological correlates of protection, TB diagnoses in children, and the need for clinical end points for determining efficacy; and -- key issues regarding the regulatory environment. • Important issues involving efficacy trials in HIV-infected and -exposed adults against TB include -- whether vaccines are safe and immunogenic, and -- the size of the sample required to achieve an efficacy outcome.
From page 108...
... CONCLUSIONS AND POLICY DISCUSSION • Rapid and accurate drug sensitivity testing should be a prerequisite for the commencement of therapy, given the amplifying role of drugs in the evolution of resistant strains. • The South African government should collaborate in the develop ment of capacity and infrastructure.


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