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VANCOUVER -- ID Biomedical announced today that analysis of laboratory data from the Company's most recent influenza human challenge study of its non-live, intranasal FluINsure vaccine confirmed the efficacy of both the one- and two-dose vaccine regimens.
The trial was a human influenza challenge study that compared subjects who had received placebo with subjects who had received one-and two-dose vaccine regimens. In the clinical trial, volunteers were selected for low pre-existing antibody titers to the challenge virus (A/Panama/2007/99), then assigned in a randomized and blinded manner to receive placebo (N = 24), a single intranasal dose of FluINsure of 30 (micro) g (N = 19), two intranasal doses of 30 (micro) g (N = 16), or a new regimen consisting of two intranasal doses of 15 (micro) g (N = 19).
Approximately one month after the vaccine regimen was completed; volunteers were challenged intranasally with the same dose of A/Panama/2007/99 virus used in the prior study. Study doctors then monitored subjects for seven days for fever, upper respiratory symptoms, cough or abnormal physical signs in their chest exam, and systemic symptoms such as weakness, fatigue, muscle aches, and headache. Those with febrile illness (i.e. fever) plus one other flu-like symptom were defined as having clinical influenza-like illness. These subjects then had the diagnosis of influenza confirmed by one of several laboratory tests for the presence of influenza virus infection.
All of the placebo subjects that were determined to have clinical influenza-like illness had laboratory confirmation of influenza infection, whereas 18 of 19 one-dose recipients (94 percent), and 100 percent of two-dose recipients at both dose levels, were free of laboratory-confirmed influenza. In comparison with placebo recipients, these results represent 75 percent efficacy in the one-dose recipients and 100% efficacy in two-dose recipients. The one- and two-dose treatment groups did not significantly differ from one another; but the comparison of all vaccine-treated subjects with placebo demonstrated a clear protective effect of FluINsure (91 percent overall efficacy p = 0.018, Fisher's exact test).
"As we previously reported, and now confirmed through laboratory confirmation of influenza infection, all of the active vaccine regimens had a clear impact on influenza illness in this challenge study," said Louis Fries, MD, ID Biomedical's vice president of clinical and regulatory affairs.
ID Biomedical also announced that FluINsure is currently in a field trial that will assess both one- and two-dose regimens, in 28 sites across Canada. This study, with a designed target sample size of 1,320 adults between 18 and 64 years of age, completed enrollment of 1,345 subjects on November 20, 2003. All subjects have had their intranasal vaccinations. Initial results from this study are expected in Q2 2004.
Source: ID Biomedical Corporation