Stage II (clinical) development of DuoChol, a low-cost, thermostable dry formulation whole-cell/B-subunit enterocoated capsule oral cholera vaccine

DuoChol is a thermostable oral cholera vaccine (OCV) consisting of a lyophilized mixture of formalin-killed isogenic V. cholerae O1 Ogawa and Inaba bacteria and cholera toxin B-subunit in an enteric capsule, which has been preclinically developed by scientists at University of Gothenburg (UGOT) with financial support from the Wellcome Trust. The present application is now asking for support for the next stage, clinical development of DuoChol comprising GMP manufacturing, toxicity testing and Phase 1 clinical testing, which are all planned to be undertaken in Sweden. The phase 1 study will be a randomized, investigator blinded, parallel groups, active-controlled safety and immunogenicity study, where DuoChol will be compared with a WHO prequalified comparator OCV, Dukoral™, in 90 healthy Swedish adults (18-65 years). Each of DuoChol and Dukoral™ will be given twice orally as capsules and liquid suspension, respectively 2 weeks apart. Participants will be followed up for 2 weeks after each dose for immunogenicity (blood samples at Day 0, Day 14 prior to the first and second vaccinations, respectively, and Day 28, and for safety surveillance for 1 month after the last dose). The project will be coordinated by the International Vaccine Institute (IVI) with UGOT as a collaborator.