PolyI:polyC12U adjuvant-combined intranasal vaccine protects mice against highly pathogenic H5N1 influenza virus variants.

The highly pathogenic avian H5N1 influenza virus has the potential to incite a global pandemic. Therefore, there is an urgent need to develop effective vaccines against these viruses. Because it is difficult to predict which strain of influenza will cause a pandemic, it is advantageous to develop vaccines that will confer cross-protective immunity against variants of the influenza virus. Recently, we reported that the Toll-like receptor 3 agonist, polyI:polyC(12)U (Ampligen), has been proven to be safe in a Phase III human trial, and is an effective mucosal adjuvant for intranasal H5N1 influenza vaccination. Intranasal administration of an Ampligen adjuvanted pre-pandemic H5N1 vaccine (NIBRG14), which was derived from the A/Vietnam/1194/2004 strain, resulted in the secretion of vaccine-specific IgA and IgG in nasal mucosa and serum, respectively, and protected mice against homologous A/Vietnam/1194/2004 and heterologous A/Hong Kong/483/97 and A/Indonesia/6/2005 viral challenge.