The trial was primarily designed to study the safety and tolerability of Immunose™ FLU in healthy adults, 18-39 years of age. The clinical phase of the study was conducted between late October 2016 and early January 2017 at two clinics in Sweden. A total of 162 subjects were dosed in the study and 159 subjects completed all visits.
Immunose™ FLU formulations with different concentrations of Endocine™ were studied, as well as a placebo and nasal and injected comparator products. The reported adverse events were mostly mild or moderate and the most common adverse events in the Immunose™ FLU groups were transient irritation and pain in the throat.
No subjects withdrew due to adverse events and there was a high percentage (98 %) of subjects who completed the clinical phase of the study. One serious adverse event (bacterial infection in the skin) was reported, and was deemed not related to the study product.
“We are happy to once again confirm the good safety of our nasal technology platform,” said Dr. Anna-Karin Maltais, Chief Scientific Officer and continued: “Now we are looking forward to the results of the extensive immunological analyses. The evaluation of the immune responses induced by Immunose™ FLU is expected to be reported in third quarter 2017”.
Dr. Hans Arwidsson, Chief Executive Officer, added “The positive safety results obtained in adults is an important milestone, which strengthens us on our path towards a better influenza vaccine for children.”