Age-descending Study to Evaluate the Safety and Immunogenicity of the Cholera Conjugate Vaccine in Adults and Children

This Phase II study tests the safety and immune response produced by a new cholera vaccine (OSP:rTTHc conjugate cholera vaccine, or CCV) given as one or two doses, with or without an aluminum adjuvant, in people living in cholera-endemic regions. Cholera is a severe diarrheal disease spread through contaminated water that kills hundreds of thousands annually in developing countries, and better vaccines are needed — especially for young children. Adults aged 18–45 and children aged 1–17 in good general health who are willing to participate and can comply with the study schedule are eligible; children under 5 must also meet weight-for-height standards. Participation involves receiving one or two injections (or oral doses of a comparison vaccine for younger children) 6 months apart, plus blood draws to measure immune responses and monitoring for side effects. This summary was generated with AI assistance and is intended to help patients understand the study in plain language.