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

Ranadhir Dey, Jalal Alshaweesh, Kamaleshwar P. Singh, Patrick Lypaczewski, Subir Karmakar, Laura Klenow, Kayla Paulini, Swarnendu Kaviraj, Shaden Kamhawi, Jesus G. Valenzuela, Sanjay Singh (), Shinjiro Hamano (), Abhay R. Satoskar (), Sreenivas Gannavaram (), Hira L. Nakhasi () and Greg Matlashewski ()
Additional contact information
Ranadhir Dey: Division of Emerging and Transfusion Transmitted Diseases, CBER, FDA
Jalal Alshaweesh: 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
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

Nature Communications, 2023, vol. 14, issue 1, 1-11

Abstract: 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.

Date: 2023
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DOI: 10.1038/s41467-023-42732-2

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