Cookies on this website

We use cookies to ensure that we give you the best experience on our website. If you click 'Accept all cookies' we'll assume that you are happy to receive all cookies and you won't see this message again. If you click 'Reject all non-essential cookies' only necessary cookies providing core functionality such as security, network management, and accessibility will be enabled. Click 'Find out more' for information on how to change your cookie settings.

Efforts to control the tuberculosis (TB) epidemic have been challenged by both the geographical overlap with the HIV pandemic, and the emergence of multi - and extensively - drug-resistant strains of Mycobacterium tuberculosis. There is, therefore, an urgent global need for an improved vaccine. However, the development of an improved vaccine is scientifically and logistically challenging. Immunological correlates or biomarkers of protection are not known and there is no perfect preclinical animal model with which to predict success in humans. Indeed, vaccine development in general is time-consuming and costly. One of the many road-blocks to the development of new TB vaccines is the availability of field sites that are suitable for large scale Phase IIb/III efficacy testing. Because disease incidence is low, even though prevalence is high, Phase IIb efficacy trials involve several thousand subjects, and require lengthy follow-up. Phase III licensure trials will need to be even larger, and are likely to require the involvement of multiple field sites. There is currently inadequate capacity within high-burden TB countries to conduct these essential trials. We need to invest now to expand current capacity if we are to reduce the time taken to develop new vaccines.

Type

Journal article

Journal

Indian J Exp Biol

Publication Date

06/2009

Volume

47

Pages

445 - 446

Keywords

Clinical Trials as Topic, Developing Countries, Disease Outbreaks, Humans, Tuberculosis, Tuberculosis Vaccines