title: Methods to Evaluate the Preclinical Safety and Immunogenicity of Genetically Modified Live-Attenuated Leishmania Parasite Vaccines.
abstract: Live-attenuated parasite vaccines are being explored as potential vaccine candidates since other approaches of vaccination have not produced an effective vaccine so far. In order for live-attenuated parasite vaccines to be tested in preclinical studies and possibly in clinical studies, the safety and immunogenicity of these organisms must be rigorously evaluated. Here we describe methods to test persistence in the immunized host and immunogenicity, and to identify biomarkers of vaccine safety and efficacy with particular reference to genetically attenuated Leishmania parasites.
authors.affiliation: Laboratory of Emerging Pathogens, Division of Emerging and Transfusion Transmitted Diseases, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA. Sreenivas.gannavaram@fda.hhs.gov.
authors.forename: Sreenivas
authors.initials: S
authors.lastname: Gannavaram
authors.affiliation: Laboratory of Emerging Pathogens, Division of Emerging and Transfusion Transmitted Diseases, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA.
authors.forename: Parna
authors.initials: P
authors.lastname: Bhattacharya
authors.affiliation: Laboratory of Emerging Pathogens, Division of Emerging and Transfusion Transmitted Diseases, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA.
authors.forename: Ranadhir
authors.initials: R
authors.lastname: Dey
authors.affiliation: Laboratory of Emerging Pathogens, Division of Emerging and Transfusion Transmitted Diseases, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA.
authors.forename: Nevien
authors.initials: N
authors.lastname: Ismail
authors.affiliation: National Institute of Pathology, Safdarjung Hospital Campus, New Delhi, 110029, India.
authors.forename: Kumar
authors.initials: K
authors.lastname: Avishek
authors.affiliation: National Institute of Pathology, Safdarjung Hospital Campus, New Delhi, 110029, India.
authors.forename: Poonam
authors.initials: P
authors.lastname: Salotra
authors.affiliation: Institute of Molecular Medicine, 254 Okhla Industrial Estate Phase 3, New Delhi, 110020, India.
authors.forename: Angamuthu
authors.initials: A
authors.lastname: Selvapandiyan
authors.affiliation: Departments of Pathology and Microbiology, Wexner Medical Center, The Ohio State University, Columbus, OH, 43210, USA.
authors.forename: Abhay
authors.initials: A
authors.lastname: Satoskar
authors.affiliation: Laboratory of Emerging Pathogens, Division of Emerging and Transfusion Transmitted Diseases, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA.
authors.forename: Hira L
authors.initials: HL
authors.lastname: Nakhasi
mesh_terms: D000818:Animals; D015415:Biomarkers / Q000378:metabolism; D002462:Cell Membrane / Q000469:parasitology; D004353:Drug Evaluation, Preclinical / Q000379:methods*; D005260:Female; D005818:Genetic Engineering; D007113:Immunity, Innate; D007891:Leishmania / Q000276:immunology*; D008264:Macrophages / Q000166:cytology; D051379:Mice; D016052:Protozoan Vaccines / Q000009:adverse effects* / Q000235:genetics / Q000276:immunology*; D012449:Safety; D014613:Vaccines, Attenuated / Q000009:adverse effects / Q000235:genetics / Q000276:immunology
chemical_list: D015415:Biomarkers; D016052:Protozoan Vaccines; D014613:Vaccines, Attenuated
keywords: Biomarkers; Immune suppression; Immunogenicity; Innate immunity; Non-pathogenicity; Persistence; Protective antigens; Safety