Based on this exciting discovery, we hypothesized that the M1 exposed region could serve as the basis for a completely new type of universal therapy and a universal vaccine against all Type A viruses, including pandemic influenzas. To test our hypothesis, we tested whether one antibody could neutralize virus replication in various in vitro experiments. It did. We then tested whether the antibody could neutralize virus in infected animals. It did.*Cell-based testing has confirmed that a single antibody can neutralize influenza viruses with these M1 sequence variants. This indicates that one antibody specificity can neutralize all Type A viruses. In a murine passive immunization experiment in which a lethal dose of influenza virus was pre-mixed with antibody and administered intranasally, this novel antibody conferred full protection, whereas control animals receiving non-neutralizing antibody with virus all died. These data suggest that both a passive antibody as well as an active antibody response (such as is produced upon vaccination with this engineered peptide) can confer protection against all Type A and pandemic influenza strains.  We then tested whether a peptide containing epitope, when used by itself, could induce an immune response in animals. It did. We then tested whether the peptide, when used as a vaccine, could confer protection from viral challenges. It appears to have done so.*We confirmed that animals immunized with the engineered peptide immunogen developed abundant antibodies that effectively neutralized Type A influenza in cell-based assays.

When the engineered peptide was used for in vivo, lethal and nonlethal viral challenge studies in both mice and swine vaccinated with the engineered peptide, the test vaccine yielded data consistent with protection from and clearance of the viruses. Thus, with optimization, we believe we have an excellent basis for a universal Type A influenza vaccine.