Technical product attributes in development of an oral enteric vaccine for infants

Abstract

Development of an oral enteric vaccine for infants is important for Shigella and enterotoxigenic Escherichia coli (ETEC) vaccine development. At a recent workshop titled “Technical Product Attributes in Development of an Oral Enteric Vaccine for Infants,” at the 2nd International Vaccines Against Shigella and ETEC Conference (VASE Conference), the preferred product attributes for development were discussed for these vaccines. The aims of this workshop were to identify gaps and gather opinions from key experts from preclinical, process development, manufacturing, regulatory, and clinical areas to fine-tune and refine key target product attributes for infant oral vaccine development. The workshop used some examples of marketed oral infant vaccines to discuss potential improvements that can be made, such as inclusion of preservatives, multidose vials, and antacid buffer presentation (liquid or lyophilized) in novel oral enteric vaccine development.