BIODIEM FLU VACCINE ‘MAY CONTROL PANDEMICS’
December 9th 2008 12:00
Friday December 5, 2008
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BIODIEM
Biodiem says phase II studies of an H5N2 live influenza vaccine candidate show it “may be effective in helping to control a pandemic outbreak of influenza”.
Biodiem said the safety and immunogenicity data published in the peer reviewed Journal of Influenza and Other Respiratory Viruses were completed at the Institute of Experimental Medicine in St Petersburg, Russia under a protocol approved by the Medical Ethics Committee of the Ministry of Health of the Russian Federation.
The phase II trial was conducted as a double-blind control study with 100 participants aged 18-49 years assigned in a 2:1 ratio of vaccine or placebo.
Peripheral blood specimens and nasal swabs were collected from volunteers before vaccination, 21 days after the first dose vaccination and 21 days after the second dose of vaccination. Volunteers in each group were given two doses of vaccine 21 days apart or two doses of placebo.
The immunogenicity of the vaccine was tested through assessing sera for hemagglutination-inhibition (HI) of H5 specific antibodies; determining virus neutralizing antibodies to H5N2 and H5N1 through micro-neutralization assays; and identification of influenza virus-specific IgA antibodies in nasal swabs by enzymelinked immunosorbent assays (ELISA).
The key results of the study indicate that the vaccine was safe and lowly reactogenic with no fever reactions.
After revaccination 47.1 percent to 54.8 percent of subjects showed an equal to, or greater than, four-fold seroconversion of HAI antibodies to A(H5N2) antigen and 29.4 percent to 30.4 percnet were seroconverted to A(H5N1) antigen.
Biodiem said virus neutralizing antibodies levels in sera of volunteers were similar to those shown in the HAI test and the virus-specific nasal IgA antibody response after two vaccine doses demonstrated significant increases of an equal to or greater than four fold rise in SIgA antibodies, 65 percent geometric mean titres and a rise in SIgA antibodies compared to a single dose.
Biodiem director and Head of Virology Department at the Institute of Experimental Medicine Prof Larisa Rudenko said “a live attenuated influenza vaccine candidate prepared using non-pathogenic avian A (H5N2) strain was well-tolerated in these studies”. “The vaccine elicited clear serum and local immune responses, whilst also showing cross-reactivity to the A(H5N1) antigen in the HAI test,” Prof Rudenko said.
Biodiem managing director Dr Andrew O’Brien said the results “demonstrate that a live attenuated vaccine may be effective in helping to control a pandemic outbreak of influenza”.
“The data from Prof Rudenko and colleagues accepted for publication in the Journal of Influenza and Other Respiratory Viruses further illustrates the world leading work being completed at the IEM for Biodiem in the field of influenza vaccine research,” Dr O’Brien said.
Biodiem was untraded at seven cents.
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