Volume 66, Issue 4
  • ISSN: 0002-9637
  • E-ISSN: 1476-1645


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.


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