Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Emergent BioSolutions has announced that the final analysis from a randomized, placebo-controlled, blinded Phase II clinical study reaffirmed that its single-dose, drinkable typhoid vaccine candidate was highly immunogenic and well-tolerated with an acceptable safety profile in the population studied.
Subscribe to our email newsletter
For the study, a total of 151 Vietnamese children between five and 14 years of age were enrolled. A total of 101 children received the vaccine candidate and 50 children received placebo. Study results showed that 97% of the children dosed developed an immune response, which was defined as an increase in Salmonella typhi LPS-specific IgG antibody levels and/or Salmonella typhi LPS-specific IgA antibody levels in the blood, suggestive of systemic and mucosal protective immunity, respectively. This represented a statistically significant difference from the placebo group.
There were no safety concerns following administration of a single dose of the drinkable typhoid vaccine candidate. The proportion of subjects reporting adverse events was similar for the vaccinated group (26%) and placebo group (22%); this difference was not statistically significant.
Fuad El-Hibri, chairman and CEO of Emergent BioSolutions, said: “We are pleased that the full analysis of the data from this Phase II study reaffirms that our typhoid vaccine candidate met the pre-established clinical endpoints. These data are encouraging and indicate great promise regarding both the safety and efficacy of what would be the first single-dose, drinkable typhoid vaccine.”