RT Journal Article SR Electronic T1 Characterization of a new Leishmania major isolate for use in a controlled human infection model JF bioRxiv FD Cold Spring Harbor Laboratory SP 2020.08.12.245936 DO 10.1101/2020.08.12.245936 A1 Helen Ashwin A1 Jovana Sadlova A1 Barbora Vojtkova A1 Tomas Becvar A1 Patrick Lypaczewski A1 Eli Schwartz A1 Elizabeth Greensted A1 Katrien Van Bocxlaer A1 Marion Pasin A1 Kai S. Lipinski A1 Vivak Parkash A1 Greg Matlashewski A1 Alison M. Layton A1 Charles J. Lacey A1 Charles L. Jaffe A1 Petr Volf A1 Paul M. Kaye YR 2020 UL http://biorxiv.org/content/early/2020/08/12/2020.08.12.245936.abstract AB Leishmaniasis is widely regarded as a vaccine-preventable disease, but the costs required to reach pivotal Phase 3 studies and uncertainty about which candidate vaccines should be progressed into human studies significantly limits progress in vaccine development for this neglected tropical disease. Controlled human infection models (CHIM) provide a pathway for accelerating vaccine development and to more fully understand disease pathogenesis and correlates of protection. Here, we describe the isolation, characterization and GMP manufacture of a new clinical isolate of Leishmania major. Two fresh isolates of L. major from Israel were initially compared by genome sequencing, in vivo infectivity and drug sensitivity in mice, and development and transmission competence in sand flies, allowing one (L. major_MRC-02) to be selected for GMP production. This study addresses a major roadblock in the development of vaccines for leishmaniasis, providing a key resource for CHIM studies of sand fly transmitted cutaneous leishmaniasis.Competing Interest StatementPK is co-author of a patent protecting the gene insert used in candidate vaccine ChAd63-KH (Europe 10719953.1; India 315101).