Immune Non-Inferiority, Safety and Lot-to-Lot Consistency of Oral Cholera Vaccine-Simplified Compared to Shanchol™

Summary

This study is to evaluate immune non-inferiority, safety and lot-to-lot consistency of OCV-S compared to Shanchol™ in 1 to 40 years old healthy Nepalese participants. The investigators hypothesize that the simplified formulation is able to induce non-inferior immunogenicity compared to licensed OCV, Shanchol™.

Timeline

Start

2021-10-06

Primary completion

2022-12-22

Completion

2023-03-21

Publications

• Song KR, Chapagain RH, Tamrakar D, Shrestha R, Kanodia P, Chaudhary S, Wartel TA, Yang JS, Kim DR, Lee J, Park EL, Cho H, Lee J, Thaisrivichai P, Vemula S, Kim BM, Gupta B, Saluja T, Pansuriya RK, Ganapathy R, Baik YO, Lee YJ, Jeon S, Park Y, Her HL, Park Y, Lynch JA. Safety and immunogenicity of the Euvichol-S oral cholera vaccine for prevention of Vibrio cholerae O1 infection in Nepal: an observer-blind, active-controlled, randomised, non-inferiority, phase 3 trial. Lancet Glob Health. 2024 May;12(5):e826-e837. doi: 10.1016/S2214-109X(24)00059-7.

Drugs

Indications