An improved formulation of Scandinavian Bioharmas ETEC vaccine candidate is currently being tested in an immunogenicity bridging study
An improved user-friendly formulation of the world’s most advanced ETEC vaccine candidate, ETVAX®, has been developed to meet commercial requirements. We want to ensure that the new formulation gives rise to immune responses that are not inferior to the previous formulation of the vaccine that underwent earlier testing. This is done in a phase II double-blinded, randomized study.
This week the first patient has been enrolled in the study. Apart from immunogenicity the study will also evaluate the safety and tolerability of the new formulation. The study, conducted at the Clinical Trial Center (CTC) at Sahlgrenska University Hospital in Gothenburg, is recruiting a total of 280 healthy volunteers aged 18-50. Half of the volunteers will be vaccinated with the new improved formulation of the vaccine and half with the previously tested formulation.
“The new user-friendly formulation is instrumental for a successful commercial launch. It is important that we implement and test the improved formulation prior to conducting our phase III trial on travellers. The improved formulation is a result of several years of hard work” says Nils Carlin, Chief Scientific Officer of Scandinavian Biopharma.
If you are interested to learn more about the study please read here.
