Eurocine Vaccines today announced good safety and tolerability in older adults, in the second clinical phase I/II study including their quadrivalent influenza vaccine candidate. Immunose™ FLU is a novel nose drop formulation based on the company’s technology Endocine™ and inactivated split influenza antigens.
– I am very happy that we have once again confirmed good safety, this time in older adults, a population in need of better influenza vaccines. Now we look forward to the immunological results, which are expected in October, says Dr. Anna-Karin Maltais, CSO, Vice President R&D.
The study was conducted during the influenza season 2017/2018 with the purpose to evaluate safety and tolerability, as well as serological and mucosal immune responses to four influenza strains in older adults aged 50-75. A total of 298 subjects, with a mean age of 63 years, were divided into seven treatment groups and the study was conducted at five locations throughout Sweden. The compliance was high, with 99% of the subjects completing the clinical part of the study.
No serious adverse event was reported in the Immunose™ FLU groups. The reported adverse events were mostly mild or moderate. A tolerability evaluation measuring discomfort at the administration site showed mild and transient experiences, lasting less than two hours.
With this study, the safety database has expanded to a total of over 400 subjects for the platform technology Endocine™.
The data put us exactly where we want to be for our further development and in our hunt for the next vaccine project, says Dr. Hans Arwidsson, CEO.
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This information is information that Eurocine Vaccines AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation (no. 596/2014). The information was submitted for publication, through the agency of the contact person set out above, on August 8th, 2018.