The only authorized vaccine for tuberculosis (TB) that is currently in use is BCG, a live vaccine derived from attenuated Mycobacterium bovis. It is administered in a single dose and has been extensively used due to its efficacy in preventing severe forms of TB in infants. With over 100 years of usage, and billions of doses administered, BCG has achieved a global coverage of close to 90%, which otherwise has resulted in a vast experience in production, distribution, storage, and practice. However, BCG does not offer protection against respiratory forms of TB in adults, highlighting the need for the development of new TB vaccines to control the transmission of the disease. In this context, live-attenuated vaccines, that contain a larger number of TB antigens compared to other vaccine strategies, are potential candidates that could play a crucial role in the development of a new and effective TB vaccine. Out of the 17 TB vaccine candidates under clinical development in the TB vaccine pipeline, six are in Phase 3 efficacy studies; and three of them are based on live-attenuated vaccines: revaccination with BCG, VPM1002 (based on a recombinant BCG), and MTBVAC (based on an attenuated form of Mycobacterium tuberculosis). In this chapter, we will review these three live-attenuated vaccine candidates and discuss the various trials that have been conducted are currently underway or are planned to assess their effectiveness against TB. By combining a new TB vaccine that protects against pulmonary forms of TB, together with diagnosis and treatment of the disease, we can definitively contribute to the control of TB.

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Live-Attenuated Vaccines in Clinical Trials

  • Carlos Martin,
  • Nacho Aguilo,
  • Jesus Gonzalo-Asensio

摘要

The only authorized vaccine for tuberculosis (TB) that is currently in use is BCG, a live vaccine derived from attenuated Mycobacterium bovis. It is administered in a single dose and has been extensively used due to its efficacy in preventing severe forms of TB in infants. With over 100 years of usage, and billions of doses administered, BCG has achieved a global coverage of close to 90%, which otherwise has resulted in a vast experience in production, distribution, storage, and practice. However, BCG does not offer protection against respiratory forms of TB in adults, highlighting the need for the development of new TB vaccines to control the transmission of the disease. In this context, live-attenuated vaccines, that contain a larger number of TB antigens compared to other vaccine strategies, are potential candidates that could play a crucial role in the development of a new and effective TB vaccine. Out of the 17 TB vaccine candidates under clinical development in the TB vaccine pipeline, six are in Phase 3 efficacy studies; and three of them are based on live-attenuated vaccines: revaccination with BCG, VPM1002 (based on a recombinant BCG), and MTBVAC (based on an attenuated form of Mycobacterium tuberculosis). In this chapter, we will review these three live-attenuated vaccine candidates and discuss the various trials that have been conducted are currently underway or are planned to assess their effectiveness against TB. By combining a new TB vaccine that protects against pulmonary forms of TB, together with diagnosis and treatment of the disease, we can definitively contribute to the control of TB.