Tuberculosis future or investigational therapies

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1] ; Associate Editor(s)-in-Chief: Mashal Awais, M.D.[2]; Ammu Susheela, M.D. [3] ; Marjan Khan M.B.B.S.[4]

With emergence of new drug-resistant tuberculosis, the role of future therapies is crucial in curbing outbreaks. The new drugs should be more effective than the current regimen and a few drugs in clinical trials have been showing promising results.

Any future regimen must fulfill the following recommendations: ^[1]

• It should not have more than a maximum duration of 6 months
• The dosing schedule must be simple
• The ideal number of drugs should not exceed 3-5 drug from a different class
• It should have a 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 orally
• It should have minimum interaction with antiretroviral drugs.
• It should have at least one new class of drug

• Neonatal BCG vaccination is partially effective at protecting infants and children, especially from the most severe complications of TB disease.^[3]
• BCG is poorly effective at protecting against pulmonary disease in adults, and hence at decreasing Mycobacterium tuberculosis transmission.^[3]
• A new novel vaccine is needed to reduce the incidence and mortality of tuberculosis; a vaccine that is effective in adult individuals who have not yet been infected with mycobacterium tuberculosis, in addition to in those with latent mycobacterium tuberculosis infection.^[3]
• This new novel vaccine will also provide the best way to counteract accelerating spread of multi-drug resistant tuberculosis.^[3]
• To this date, this new vaccine has not been developed but many TB vaccine candidates are in pipeline.^[3]
• Potential vaccines are either whole-cell vaccines, adjuvanted proteins, and vectored subunit vaccines.^[3]
• 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.^[3]
• The vaccine PPCs are built through a large consensus building process and originate from interactions with different stakeholders.^[3]
• The new vaccine, made by GSK and now known as M72/AS01E, was tested in about 3,300 adults in Kenya, South Africa, and Zambia.
• All of them already had latent tuberculosis, Of those who got two doses of the GSK vaccine, only 13 developed active tuberculosis during three years of follow-up, according to the new study which was published in The New England Journal of Medicine. On the other hand, 26 of those who received a placebo progressed to active tuberculosis.

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