Tuberculosis future or investigational therapies
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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1] ; Associate Editor(s)-in-Chief: Ammu Susheela, M.D. [2]
Overview
Since new drug resistant tuberculosis have been emerging, the role of future therapies is vital in curbing outbreaks. The new drugs should be more effective than the current regimen and a few drugs in clinical trials have been showing good results.
Future investigations
Principles of future investigations
Any future regimen should satisfy the following principles. [1]
- It should not have more than a maximum duration of 6 months
- The dosing schedule must be simple
- The number of drugs in it should be ideally not more than 3-5 drug each from a different class
- It should have minimum side effect profile so that we could have minimum monitoring
- It should be effective against MDR, XDR and XXDR strains
- It should be administered per orally
- It should have minimum interaction with anti retroviral drugs.
- It should have atleast one new class of drug
New drugs involved in clinical trial for treatment of tuberculosis
| Drug | Phase | Class |
|---|---|---|
| Moxifloxacin | Phase III | Fluoroquinolone |
| Linezolid | Phase II | Oxazolidinone |
| AZD-5847 | Phase II | Oxazolidinone |
| Sutezolid | Phase II | Oxazolidinone |
| Clofazimine | Phase II | Riminophenazine |
| SQ-109 | Phase II | Ethylenediamine |
| PA-824 | Phase IIb | Nitroimidazole |
| Delamanid | Phase III | Nitroimidazole |
| Bedaquiline | Phase III | Diarylquinoline |
| Data provided by WHO[2] | ||
Tuberculosis vaccine development
- Neonatal BCG vaccination is partially effective at protecting infants and children, particularly from the most severe consequences of TB disease.
- BCG is poorly protective against pulmonary disease in adults, and therefore at reducing Mycobactarium tuberculosis transmission.
- A new novel vaccine is warranted in decreasing the incidence and mortality of Tuberculosis; a vaccine that is effective in adult individuals who have not yet been infected with Mycobactarium tuberculosis, as well as in those with latent Mycobacterium tuberculosis infection.
- This new novel vaccines will also offer the best chance to contain the accelerating spread of multi-drug resistant tuberculosis.
- To this date this new vaccine has not been develop but many TB vaccine candidate are in pipeline.
- Potential vaccines are either whole cell vaccines, adjuvanted proteins, and vectored subunit vaccines.
- Up till now, there was no communicated consensus as to the preferred product characteristics (PPC) that would adequately support favorable policy recommendations for implementation where needed.
- A document highlighting WHO preferred Product Characteristics (PPC) for new TB vaccines has been devised based on a high unmet medical need and technical feasibility assessment.
- The preferred product characteristics (PPC) describe WHO preferences for parameters of vaccines, in particular their indications, target groups, possible immunization strategies, and features of clinical data desired related to safety and efficacy, supportive of policy decision making.
- The vaccine PPCs are built through a wide consensus building process and result from interactions with a variety of stakeholders.