{
  "abstract": "We extend recent conversation about the ethics of human challenge trials to tuberculosis (TB). TB challenge studies could accelerate vaccine development, but ethical concerns regarding risks to trial participants and third parties have been a limiting factor. We analyse the expected social value and risks of different challenge models, concluding that if a TB challenge trial has between a 10% and a 50% chance of leading to the authorisation and near-universal delivery of a more effective vaccine 3–5 years earlier, then the trial would save between 26 400 and 1 100 000 lives over the next 10 years. We also identify five important ethical considerations that differentiate TB from recent human challenge trials: an exceptionally high disease burden with no highly effective vaccine; heightened third party risk following the trial, and, partly for that reason, uniquely stringent biosafety requirements for the trial; risks associated with best available TB treatments; and difficulties with TB disease detection. We argue that there is good reason to consider conducting challenge trials with attenuated strains like Bacillus Calmette-Guérin or attenuated Mycobacterium tuberculosis.",
  "authors": [
    {
      "affiliations": [
        "Columbia University, New York, New York, USA",
        "1Day Sooner, Baltimore, Maryland, USA",
        "Oxford Uehiro Centre for Practical Ethics, University of Oxford, Oxford, UK"
      ],
      "name": "Abie Rohrig"
    },
    {
      "affiliations": [
        "1Day Sooner, Baltimore, Maryland, USA"
      ],
      "name": "Josh Morrison"
    },
    {
      "affiliations": [
        "1Day Sooner, Baltimore, Maryland, USA"
      ],
      "name": "Gavriel Kleinwaks"
    },
    {
      "affiliations": [
        "Oxford Uehiro Centre for Practical Ethics, University of Oxford, Oxford, UK"
      ],
      "name": "Jonathan Pugh"
    },
    {
      "affiliations": [
        "Jenner Institute, University of Oxford Nuffield Department of Medicine, Oxford, Oxfordshire, UK"
      ],
      "name": "Helen McShane"
    },
    {
      "affiliations": [
        "Oxford Uehiro Centre for Practical Ethics, University of Oxford, Oxford, UK",
        "Centre for Biomedical Ethics, Yong Loo Lin School of Medicine, National University of Singapore, Singapore",
        "Biomedical Research Group, Murdoch Childrens Research Institute, Melbourne, Victoria, Australia"
      ],
      "name": "Julian Savulescu"
    }
  ],
  "title": "Exploring the ethics of tuberculosis human challenge models",
  "uid": "5a22a77d-63e9-54a1-8c95-4ccfde4b9f2d"
}