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Despite scientific progress, a risk-averse culture has stalled new tuberculosis (TB) vaccine development. Embracing risk is crucial to diversify candidates and advance TB vaccines into clinical trials.

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Area of Science:

  • Vaccinology
  • Infectious Diseases
  • Immunology

Background:

  • The existing Bacille Calmette Guerin (BCG) vaccine offers partial, long-term protection against tuberculosis (TB), proving vaccine-mediated protection is achievable.
  • Substantial advancements have been made in TB vaccine development, including platform technologies, antigen identification, and immune correlates of risk.

Purpose of the Study:

  • To discuss progress and persistent challenges in the development of new tuberculosis vaccines.
  • To highlight the need for a cultural shift towards embracing risk in TB vaccine research and development.

Main Methods:

  • Review of progress in vaccine platforms, antigen discovery, and animal/human models for TB vaccine development.
  • Exploration of experimental medicine studies on vaccine routes and development of controlled human infection models.
  • Application of novel approaches in late-stage clinical development, including alternative endpoints to reduce trial duration and cost.

Main Results:

  • Few TB vaccine candidates have entered clinical trials in recent years, and even fewer have progressed to efficacy trials.
  • A culture of risk aversion has led to underutilization of data from "failed" trials, limited funding, and a lack of diversity in vaccine candidates.
  • Despite available technologies and models, the clinical pipeline for TB vaccines remains stagnant.

Conclusions:

  • Scientific progress in TB vaccine development is significant, but clinical progression is hindered by risk aversion.
  • A paradigm shift is needed to embrace calculated risks, diversify the pipeline, and accelerate the development of effective TB vaccines.
  • Valuing knowledge from all trials, including "failures," and fostering innovation are essential to overcome current stagnation.