Emergent's typhoid vacc meets Ph II endpoints

Maryland, USA-based Emergent BioSolutions says that preliminary results from a recently-completed, randomized, placebo-controlled Phase II clinical study demonstrated that its single-dose, drinkable typhoid vaccine candidate achieved key endpoints for safety and immunogenicity. This recruited children between five and 14 years of age, a total of 101 of whom received the vaccine candidate and 50 were given placebo. The vaccine candidate and placebo were allocated in a blinded manner. This study, which was conducted in Vietnam, is the first of this product in a pediatric population in a region where typhoid is endemic and was performed in collaboration with Oxford University of the UK and the Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam, and financially supported by the Wellcome Trust.

The data from this Phase II clinical study, which is still being analyzed, support the following key findings:

- the vaccine was immunogenic and met the pre-defined criterion of an overall immune response rate of greater than 50%, with 95% confidence;