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Peer-reviewedCC BYNature Immunology

mRNA-based tuberculosis vaccines BNT164a1 and BNT164b1 are immunogenic, well tolerated and efficacious in rodent models

  • Neha Agrawal1
  • Louis S. Ates2
  • Stefan A. Schille1
  • Anuhar Chaturvedi1
  • Janina Vogt1
  • Nataša Vukovic1
  • Charles L. Dulberger3
  • Annette B. Vogel1
  • Jan Diekmann1
  • Mustafa Diken4,5
  • Uğur Şahin1,6
6 affiliations
  1. 1BioNTech SE, Mainz, Germany
  2. 2BioNTech SE, Mainz, Germany. [email protected]
  3. 3BioNTech US, Cambridge, MA, USA
  4. 4BioNTech SE, Mainz, Germany. [email protected]
  5. 5Translational Oncology at the University Medical Center of the Johannes Gutenberg-University Mainz (TRON), Mainz, Germany. [email protected]
  6. 6Helmholtz Institute for Translational Oncology (HI-TRON), Mainz, Germany
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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 ).

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Cite

BibTeXRIS
BibTeX
@article{agrawal2026mrnabased,
  title = {{mRNA-based tuberculosis vaccines BNT164a1 and BNT164b1 are immunogenic, well tolerated and efficacious in rodent models}},
  author = {Neha Agrawal and Louis S. Ates and Stefan A. Schille and Anuhar Chaturvedi and Janina Vogt and Nataša Vukovic and Charles L. Dulberger and Annette B. Vogel and Jan Diekmann and Mustafa Diken and Uğur Şahin},
  journal = {Nature Immunology},
  year = {2026},
  month = jun,
  doi = {10.1038/s41590-026-02545-z},
  url = {https://doi.org/10.1038/s41590-026-02545-z},
  note = {CC BY},
}
RIS
TY  - JOUR
TI  - mRNA-based tuberculosis vaccines BNT164a1 and BNT164b1 are immunogenic, well tolerated and efficacious in rodent models
AU  - Neha Agrawal
AU  - Louis S. Ates
AU  - Stefan A. Schille
AU  - Anuhar Chaturvedi
AU  - Janina Vogt
AU  - Nataša Vukovic
AU  - Charles L. Dulberger
AU  - Annette B. Vogel
AU  - Jan Diekmann
AU  - Mustafa Diken
AU  - Uğur Şahin
PY  - 2026
DA  - 2026/06/12
JO  - Nature Immunology
DO  - 10.1038/s41590-026-02545-z
UR  - https://doi.org/10.1038/s41590-026-02545-z
AB  - 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 ).
SN  - 1529-2908
SN  - 1529-2916
ER  -