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to use them in the assessment of new drug or vaccine candidates developed by other research groups, with which stable collaboration networks can be established to facilitate the evolution of these candidates into clinical development .
2 . Design and evaluation of new vaccine candidates against tuberculosis
The current BCG tuberculosis vaccine offers low protection against the respiratory forms of tuberculosis, among which are found the drug-resistant strains, as well as the high incidence of AIDS in third world countries and the difficulties in following treatment programmes, which makes a new, effective vaccine necessary to substitute the current BCG vaccine .
Since 1999, our efforts have been invested in creating a new, attenuated tuberculosis vaccine, studying the test concepts and developing this new attenuated live vaccine . An attenuated vaccine has been created based on the double deletion of the genes phoP and fadD the MTBVAC. The first vaccine based on attenuated M. tuberculosis satisfying the “Geneva consensus” safety criteria for entry of new TB vaccines into clinical trials . Taken together, GMP production of freeze-dried MTBVAC and rigorous preclinical characterization from mouse to non-human primates provide the bases for entry into first-in-human clinical trials .
3 . Design and evaluation of new therapeutic strategies against tuberculosis (resistance, action and discovery of new drugs).
Anti-tuberculosis therapy constitutes one of the fundamental pillars in the battle against this disease . The success of the treatment can be compromised when the strains acquire resistance to any one of the drugs used in the treatment . Then the active drug arsenal against this disease is extremely limited . In addition various mechanisms of intrinsic drug resistance in M . tuberculosis could play a major role in favouring the acquisition of mutations that confer even greater levels of resistance .
Based on these facts, discovering new, active drugs against M. tuberculosis is one of the main priorities of tuberculosis research at a world level . Insights have been made in the usefulness of efflux inhibitors have companion drugs in the therapy of tuberculosis .
4 . Design and evaluation of new diagnostic and molecular epidemiology methods in tuberculosis.
Effective control of TB is based on the rapid detection of M . tuberculosis, followed by the implementation of an adequate anti-tuberculosis therapy . As a result of several epidemiologic studies, new analytical challenges have been identified, for which a response must be given . Mainly, greater speed to obtain the genotypes, to identify the earliest transmission events, and thus facilitate the intervention is required . Likewise, the precision in identifying the transmission environment must be improved . CIBERES researchers have made important contributions in the diagnosis of latent TB infection and TB disease . Molecular techniques are essential tools to improve the control of tuberculosis . These techniques allow the strains to be differentiated from different clonal origins with greater efficiency .
Main results until the end of 2014
In the field of Tuberculosis, CIBERES highlights the following results:
• Development of a new prophylactic tuberculosis vaccine (MTB VAC) which can, in the near future, replace the current BCG vaccine . Phase I clinical trial was conducted in 2013 and phase II clinical trial is currently underway .
• Development and evaluation of a new therapeutic tuberculosis vaccine (RUTI) . Phase III clinical trials in South Africa have ended .
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