Japan MHLW grant for flu vaccine development

Japan's Ministry of Health, Labor and Welfare has issued an authorization to its National Institute of Infectious Diseases approving the latter's budget to advance studies indicating that an H5N1 influenza vaccine co-administered intranasally with US firm Hemispherx' experimental therapeutic double stranded RNA (dsRNA) Ampligen (poly I; poly C12U) protected against mutated strains of the virus. Additinally, the seasonal trivalent influenza vaccine co-administered intranasally with Ampligen maintained efficacy even when challenged with the H5N1 influenza virus.

The trials are to be lead by the NIID's Hideki Hasegawa, with whom Hemispherx has been collaborating on the earlier animal studies. Enlarged studies, scheduled over three years, will focus initially on efficacy and stability as it pertains to the formulation of the vaccine and adjuvant (Ampligen). Subsequent evaluations will focus on Good Laboratory Practices studies required for regulatory submission including pharmacology, safety, toxicology, reproduction and carcinogenicity, followed by clinical studies.

Dr Hasegawa initially presented the results of his studies at the Second International Conference on Influenza Vaccines for the World in Vienna, Austria, in October 2006. In this presentation, he examined the protective efficacy of intranasal co-administration of inactivated whole-virion H5N1 vaccine with Ampligen in mice and non-human primates. Intranasal administration of a candidate influenza vaccine with Ampligen resulted in dramatically increased secretion of immunoglobulin A, which formed the basis of mucosal immunity. The induced mucosal immunity thereafter protected subjects when challenged with Vietnam, Hong Kong and Indonesian strains of the H5N1 viruses.