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Production of leishmanin skin test antigen from Leishmania donovani for future reintroduction in the field

Author

Listed:
  • Ranadhir Dey

    (Division of Emerging and Transfusion Transmitted Diseases, CBER, FDA)

  • Jalal Alshaweesh

    (Nagasaki University
    Nagasaki University)

  • Kamaleshwar P. Singh

    (Gennova Biopharmaceuticals, Hinjawadi Phase II)

  • Patrick Lypaczewski

    (McGill University)

  • Subir Karmakar

    (Gennova Biopharmaceuticals, Hinjawadi Phase II)

  • Laura Klenow

    (Division of Emerging and Transfusion Transmitted Diseases, CBER, FDA)

  • Kayla Paulini

    (McGill University)

  • Swarnendu Kaviraj

    (Gennova Biopharmaceuticals, Hinjawadi Phase II)

  • Shaden Kamhawi

    (Vector Molecular Biology Section, Laboratory of Malaria and Vector Research, National Institute of Allergy and Infectious Diseases, NIH)

  • Jesus G. Valenzuela

    (Vector Molecular Biology Section, Laboratory of Malaria and Vector Research, National Institute of Allergy and Infectious Diseases, NIH)

  • Sanjay Singh

    (Gennova Biopharmaceuticals, Hinjawadi Phase II)

  • Shinjiro Hamano

    (Nagasaki University
    Nagasaki University)

  • Abhay R. Satoskar

    (Ohio State University)

  • Sreenivas Gannavaram

    (Division of Emerging and Transfusion Transmitted Diseases, CBER, FDA)

  • Hira L. Nakhasi

    (Division of Emerging and Transfusion Transmitted Diseases, CBER, FDA)

  • Greg Matlashewski

    (McGill University)

Abstract

The leishmanin skin test was used for almost a century to detect exposure and immunity to Leishmania, the causative agent of leishmaniasis, a major neglected tropical disease. Due to a lack of antigen used for the intradermal injection, the leishmanin skin test is no longer available. As leishmaniasis control programs are advancing and new vaccines are entering clinical trials, it is essential to re-introduce the leishmanin skin test. Here we establish a Leishmania donovani strain and describe the production, under Good Laboratory Practice conditions, of leishmanin soluble antigen used to induce the leishmanin skin test in animal models of infection and vaccination. Using a mouse model of cutaneous leishmaniasis and a hamster model of visceral leishmaniasis, soluble antigen induces a leishmanin skin test response following infection and vaccination with live attenuated Leishmania major (LmCen-/-). Both the CD4+ and CD8+ T-cells are necessary for the leishmanin skin test response. This study demonstrates the feasibility of large-scale production of leishmanin antigen addressing a major bottleneck for performing the leishmanin skin test in future surveillance and vaccine clinical trials.

Suggested Citation

  • Ranadhir Dey & Jalal Alshaweesh & Kamaleshwar P. Singh & Patrick Lypaczewski & Subir Karmakar & Laura Klenow & Kayla Paulini & Swarnendu Kaviraj & Shaden Kamhawi & Jesus G. Valenzuela & Sanjay Singh &, 2023. "Production of leishmanin skin test antigen from Leishmania donovani for future reintroduction in the field," Nature Communications, Nature, vol. 14(1), pages 1-11, December.
    • Handle: RePEc:nat:natcom:v:14:y:2023:i:1:d:10.1038_s41467-023-42732-2
    DOI: 10.1038/s41467-023-42732-2
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    References listed on IDEAS

    as
    1. Wen-Wei Zhang & Subir Karmakar & Sreenivas Gannavaram & Ranadhir Dey & Patrick Lypaczewski & Nevien Ismail & Abid Siddiqui & Vahan Simonyan & Fabiano Oliveira & Iliano V. Coutinho-Abreu & Thiago DeSou, 2020. "A second generation leishmanization vaccine with a markerless attenuated Leishmania major strain using CRISPR gene editing," Nature Communications, Nature, vol. 11(1), pages 1-14, December.
    2. Helen Ashwin & Jovana Sadlova & Barbora Vojtkova & Tomas Becvar & Patrick Lypaczewski & Eli Schwartz & Elizabeth Greensted & Katrien Bocxlaer & Marion Pasin & Kai S. Lipinski & Vivak Parkash & Greg Ma, 2021. "Characterization of a new Leishmania major strain for use in a controlled human infection model," Nature Communications, Nature, vol. 12(1), pages 1-12, December.
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