title: Practical and ethical issues in the development of a vaccine against schistosomiasis mansoni.
abstract: Clinical trials to evaluate schistosomal vaccines are in progress. We discuss the desired characteristics of such a vaccine, propose a product profile, and consider the clinical and pre-clinical studies needed for its licensure, within practical and ethical constraints. We believe that licensure of a schistosomal vaccine will be greatly facilitated by resolution of the following issues: identification of the human immunoprotective antigens and mechanisms; induction of the appropriate responses by adjuvanted vaccines; understanding the effect of immunization on immunopathology; development of an improved serologic assay to determine worm burden; generation of approximately $500 million to fund the project; and development of a physical infrastructure with trained professionals in disease-endemic countries to perform Phase III clinical trials. We also believe that development of a schistosomal vaccine, while a long range goal, is possible and desirable, and we have indicated some of the practical steps that will be required to achieve this laudable accomplishment.
authors.affiliation: Division of Parasitic Diseases, National Center for Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia 30341-3724, USA. ckt1@cdc.gov
authors.forename: Charles W
authors.initials: CW
authors.lastname: Todd
authors.forename: Daniel G
authors.initials: DG
authors.lastname: Colley
mesh_terms: D000818:Animals; D026688:Bioethical Issues; D002986:Clinical Trials as Topic / Q000592:standards; D003365:Costs and Cost Analysis; D006801:Humans; D017589:Immunization Programs; D012107:Research Design; D012550:Schistosoma mansoni / Q000276:immunology*; D012555:Schistosomiasis mansoni / Q000517:prevention & control*; D014612:Vaccines / Q000009:adverse effects / Q000191:economics / Q000592:standards / Q000627:therapeutic use
chemical_list: D014612:Vaccines