ID BIOMEDICAL ANNOUNCES FINAL RESULTS FROM FIELD EFFICACY TRIAL OF ITS INTRANASAL FLU VACCINE

ID Biomedical has completed analysis of the vaccine immunogenicity and safety data from its 2003-2004 field efficacy trial of FluINsure, a nonliving intranasally delivered influenza vaccine.

The trial was carried out in 1,349 healthy subjects aged 18 to 64 in 28 Canadian sites between October 2003 and May 2004. As previously reported, both one- and two-dose FluINsure regimens were efficacious in preventing influenza-like illness (two or more symptoms) in association with a positive influenza virus culture, and no FluINsure recipient experienced febrile illness associated with culture-confirmed influenza.

The immunogenicity data from the study showed a significant rise in serum hemagglutination-inhibiting (HAI) antibody titers, a widely accepted correlate of protection against influenza disease, when vaccinees were compared to placebo recipients. In addition, significant rises in salivary secretory IgA specific for the vaccine viruses were also found for all three vaccine viruses among subjects who received the active vaccine, but not those who received placebo. Salivary secretory IgA responses were not significantly different between subjects who received the two dose regimen and those who received one dose.

Regarding safety, there was no statistically significant association of local or respiratory complaints (runny nose, stuffy nose, itchy nose, nose bleed, sneezing, sore throat, red or puffy eyes, wheezing or cough) with active vaccine when compared with placebo (saline). Similarly, neither temperature elevations nor systemic complaints (headache, muscle or joint aches, tiredness or loss of appetite) were related to receipt of FluINsure at either dosage level.

Throughout the study period, there was no statistically significant difference in the overall incidence of adverse events reported between the vaccine and placebo groups, and there was no significantly increased rate of any particular class of adverse events in vaccine recipients versus placebo recipients.