Hemispherx Ampligen Combats H5N1

Overview of H5N1

H5N1 - also called "Influenza A (H5N1) virus" – is an influenza A virus subtype that occurs mainly in birds, is highly contagious among birds, and can be deadly to them. H5N1 virus does not usually infect people, however recently the infections with these viruses have began to occur in humans.

Of the few avian influenza viruses that have crossed the species barrier to infect humans, the H5N1 virus has caused the greatest number of detected cases of severe disease and death in humans. Each day there seems to be an increasing number of infections in humans, the most prominent reports coming in from South-East Asia. This viral infection has an extremely high mortaility rate (>60%), with a lot of concern that this avian virus could cause a pandemic of new influenza in humans, once it acquires the ability for human to human transmission. To prevent such highly contageious infectious disease as influenza, it is essential to prepare effective vaccines.

A brief history of H5N1

The first outbreak of the highly pathogenic avian influenza virus H5N1 was reported in humans and birds in Hong Kong in 1997, during which 6 out of 18 infected people died. Subsequently, re-emergence of the H5N1 virus associated with a high fatality rate (greater than 60%) has been reported in southern China, Vietnam, Thailand, Cambodia, Indonesia, Turkey, and Iraq. From January 2003 to September 2008, 387 laboratory-confirmed human cases of H5N1 were reported to the World Health Organization (WHO).

World Map of H5N1 Infected Areas:

Innate immunity and adjuvant effect

Innate immunity is a set of nonspecific mechanisms that constitute the body´s naturally occurring immune response to infection by microbes at any site. In influenza virus infection, the upper respiratory mucosal surface is the effector site of the innate immune system. The innate immune system senses viral infection by recognizing a variety of viral components, including double stranded (ds) RNA, and triggering antiviral responses.

The recognition of viral infection by the innate immune system bridges the transition between innate and adaptive immune responses. We can take advantage of the mucosal innate immune response to enhance vaccine efficacy, which is here Hemispherx´s Ampligen comes into play.

Ampligen and mucosal vaccine

Seasonal influenza vaccines are prepared based on the preiction of the expected strain of aepidemic of the next season. The intranasal inoculation with both the trivalent inactivated influenza vaccine and Ampligen(r) induced cross-protection mucosal immunity to heterologous H5N1 influenza virus in mice. Intranasal inoculation with both the annual influenza vaccine and Ampligen(r) may thus represent a strategy that, in humans, can generate protective mucosal immunity against newly emerging and highly pathogenic avian influenza viruses. Ampligen is a proven and effective drug: To date, >75,000 doses of Ampligen have been administered to humans, at an average dose of 400 mg, and it has been generally well tolerated.

To evaluate the adjuvant effect of Ampligen, the protective effect of intranasal administration of vaccine and Ampligen adjuvant against homologous and teterologous H5N1 influenza virus challenge was examined. The study clearly proved that the vaccine and Ampligen adjuvant was the most effective versus all other treatment options. What is most intriguing to notice is that Ampligen may be used as an adjuvant for any other future influenza outbreak, not just Swine Flu.