The International Vaccine Institute, an international organization with a mission to discover, develop, and deliver safe, effective, and affordable vaccines for global health, began clinical development of DuoChol, a new low-cost oral cholera vaccine (OCV) in capsule form. With funding support from the Wellcome Trust and the Swedish government, IVI is preparing to conduct a Phase I clinical trial of the vaccine in Sweden.
Scientists at the University of Gothenburg developed DuoChol, a dry formulation inactivated bacterial whole cell/cholera toxin B subunit OCV with a similar composition as the world’s first WHO-prequalified OCV, DUKORAL®. While DUKORAL® as well as the currently available WHO-prequalified low-cost OCVs, Shanchol™ and Euvichol-Plus®, both developed at IVI, are drinkable vaccines, what sets DuoChol apart is its dry formulation in capsule form. This presentation improves the vaccine’s thermostability, meaning the active ingredients remain stable at higher relative temperatures for a longer duration, while also reducing its weight and volume.
Dr. Julia Lynch, Director of IVI’s Cholera Program, said: “Oral cholera vaccine is a critical tool in the WHO’s global program for cholera control and elimination. However, with a need that exceeds the current supply of vaccine, the market requires additional producers as well as innovations to make vaccines that are lower cost, easier to use, and more efficacious. DuoChol, with its thermostability and light-weight capsule presentation, has the potential to simplify vaccine storage and delivery, key factors for more effective and efficient vaccination campaigns in outbreak and endemic settings.”
Prof. Jan Holmgren, co-inventor of DuoChol at the University of Gothenburg, said: “We look forward to collaborating with IVI, Valneva and Wellcome Trust in the further development and clinical testing of this novel, improved, thermostable 3rd generation OCV.”
IVI is conducting this study in partnership with Gotovax AB, a biopharmaceutical company spun off from the University of Gothenburg, and Valneva Sweden AB, the Swedish subsidiary of specialty vaccine company Valneva, that was selected to be the contract manufacturing organization (CMO). Valneva will produce DuoChol under good manufacturing practices (GMP) for pre-clinical toxicity testing and the Phase 1 trial.
Dr. Janet Hoogstraate, Managing Director of Valneva Sweden AB, said: “We are excited to work with IVI and Gotovax and look forward to leveraging the competence and experience of our team at Valneva Sweden to deliver clinical trial material for this project.”
Dr Charlie Weller, Head of Infectious Disease Prevention at Wellcome, said: “As we continue to experience a large surge in global cholera cases, the demand for vaccine far outweighs supply. Supporting IVI to take a new, low-cost oral cholera vaccine into a Phase I trial is an important step towards potentially expanding our global toolkit for this escalating disease and making these lifesaving products more accessible to those who need them most. This will be vital for helping to prevent and respond to future cholera outbreaks and save more lives.”
H.E. Anders Nordström, Swedish Ambassador for Global Health, said: “The world is presently faced with a difficult cholera situation, especially in already challenging situations of emergencies and crisis. The development of a new formulation for a low-cost oral cholera vaccine is very important news.”