Oral Cholera Vaccine reformulation

There are currently two WHO pre-qualified oral cholera vaccines in the Gavi supported stockpile and available to eligible countries for emergency or routine preventive use. Both derive from the same basic technology and contain five antigenic components. This project seeks to simplify the formulation of the oral cholera vaccine to reduce the number of components and simplify the production. Guided by input from experts in cholera, vaccine developers and regulators, a simplified formulation will be produced and evaluated in a phase III, multicenter, observer-blinded, randomized, active controlled trial to determine immune non-inferiority, safety and lot-to-lot consistency of Oral Cholera Vaccine-Simplified (OCV-S) compared to ShancholTM in 1 to 40 year old healthy Nepalese participants. If successful, the simplified formulation will reduce product unit cost and expand production capability of manufacturers.

Oral Cholera vaccine is currently in high demand with limited supply. If successful, this formulation simplification will reduce unit cost and expand supply availability of all current manufacturers using this technology.