{
  "abstract": "We designed and preclinically tested two mRNA-LNP-based vaccine candidates to protect against tuberculosis (TB). BNT164a1 and BNT164b1 encode the same eight Mycobacterium tuberculosis ( Mtb ) antigens expressed across different infection stages: Ag85A, Hrp1, ESAT-6, RpfD, RpfA, HbhA, M72, and VapB47. BNT164a1 utilizes nucleoside-unmodified mRNA, while BNT164b1 utilizes N1-methyl pseudouridine-modified mRNA. Prime-boost immunization with BNT164 candidates elicited antibody and/or T-cell responses against all antigens in three mouse strains (C57BL/6, BALB/c, and HLA-A2.1/DR1 humanized mice). The candidates demonstrated favorable safety profiles in a rat toxicity study and significantly reduced bacterial burdens of two Mtb strains in murine aerosol challenge models. BNT164 protection correlated with granuloma infiltration by CD8 + T cells with memory precursor phenotypes. In conclusion, BNT164a1 and BNT164b1 were immunogenic, well tolerated and efficacious in preclinical models and are the first mRNA-based TB vaccines to enter phase I/II clinical trials ( NCT05537038 , NCT05547464 ).",
  "abstract_shown": true,
  "affiliations": [
    "BioNTech SE, Mainz, Germany",
    "BioNTech SE, Mainz, Germany. louis.ates@biontech.de",
    "BioNTech US, Cambridge, MA, USA",
    "BioNTech SE, Mainz, Germany. mustafa.diken@biontech.de",
    "Translational Oncology at the University Medical Center of the Johannes Gutenberg-University Mainz (TRON), Mainz, Germany. mustafa.diken@biontech.de",
    "Helmholtz Institute for Translational Oncology (HI-TRON), Mainz, Germany"
  ],
  "article_type": null,
  "arxiv": null,
  "author_total": 11,
  "authors": [
    {
      "affs": [
        0
      ],
      "name": "Neha Agrawal",
      "orcid": "0000-0001-8506-6559"
    },
    {
      "affs": [
        1
      ],
      "name": "Louis S. Ates",
      "orcid": "0000-0002-2953-8010"
    },
    {
      "affs": [
        0
      ],
      "name": "Stefan A. Schille",
      "orcid": "0000-0001-5395-8368"
    },
    {
      "affs": [
        0
      ],
      "name": "Anuhar Chaturvedi",
      "orcid": "0000-0002-9597-3010"
    },
    {
      "affs": [
        0
      ],
      "name": "Janina Vogt"
    },
    {
      "affs": [
        0
      ],
      "name": "Nataša Vukovic",
      "orcid": "0000-0002-9083-2104"
    },
    {
      "affs": [
        2
      ],
      "name": "Charles L. Dulberger"
    },
    {
      "affs": [
        0
      ],
      "name": "Annette B. Vogel",
      "orcid": "0000-0002-9940-5379"
    },
    {
      "affs": [
        0
      ],
      "name": "Jan Diekmann"
    },
    {
      "affs": [
        3,
        4
      ],
      "name": "Mustafa Diken",
      "orcid": "0009-0005-4391-4042"
    },
    {
      "affs": [
        0,
        5
      ],
      "name": "Uğur Şahin",
      "orcid": "0000-0003-0363-1564"
    }
  ],
  "bibtex": "https://research.draconitic.com/paper/ba3jbfhjh482p.bib",
  "cited_by": 12,
  "doi": "10.1038/s41590-026-02545-z",
  "fulltext_url": null,
  "id": "ba3jbfhjh482p",
  "issns": [
    "1529-2908",
    "1529-2916"
  ],
  "landing_url": "https://doi.org/10.1038/s41590-026-02545-z",
  "language": "en",
  "licence": "CC-BY",
  "licence_label": "CC BY",
  "licence_source": "journal",
  "licence_url": "https://creativecommons.org/licenses/by/4.0/",
  "metadata_licence": null,
  "native_subjects": [
    [
      "openalex",
      "2725|Tuberculosis Research and Epidemiology"
    ]
  ],
  "openalex": "W4414739165",
  "pdf_url": "https://www.nature.com/articles/s41590-026-02545-z.pdf",
  "pmcid": "PMC13414557",
  "pmid": "42286358",
  "published": "2026-06-12",
  "publisher": "Nature Portfolio",
  "ris": "https://research.draconitic.com/paper/ba3jbfhjh482p.ris",
  "sources": [
    {
      "first_seen": "2026-10-30T13:26:56Z",
      "native_id": "W4414739165",
      "source": "openalex",
      "url": "https://doi.org/10.1038/s41590-026-02545-z"
    }
  ],
  "subjects": [
    {
      "field": "medicine",
      "origin": "openalex:2725|Tuberculosis Research and Epidemiology",
      "subfield": "infectious-disease"
    }
  ],
  "title": "mRNA-based tuberculosis vaccines BNT164a1 and BNT164b1 are immunogenic, well tolerated and efficacious in rodent models",
  "title_text": "mRNA-based tuberculosis vaccines BNT164a1 and BNT164b1 are immunogenic, well tolerated and efficacious in rodent models",
  "type": "peer-reviewed",
  "updated_at": "2026-11-07T13:20:59Z",
  "url": "https://research.draconitic.com/paper/ba3jbfhjh482p",
  "venue": "Nature Immunology",
  "versions": []
}