Clinical method for the immunomodulatory and vaccine adjuvant use of poly-ICLC and other dsRNAs

1) A method of treatment of human or veterinary disease selected from among the group consisting of malignant brain tumors, melanoma, prostate, breast and lung cancer, colon cancer, sarcomas, renal cell cancer, mesothelioma, leukemias, lymphomas;

• microbial infections including influenza, flavivirus infections, such as West Nile virus, Japanese encephalitis, dengue, and yellow fever, coronaviruses such as SARS, filoviruses such as Ebola and Marburg virus, influenza, poxviruses such as vaccinia and smallpox, adenovirus, hepatitis, herpesviruses infections human immunodeficiency virus, equine encephalitis, foot & mouth virus, bovine respiratory complex;
• autoimmune diseases such as multiple sclerosis, Guillain Barre syndrome, immune neuropathies, vasculitides, Crohn's disease, rheumatoic arthritis and other autoimmune diseases;
• comprising the steps of:
• administering Poly-ICLC intranasally, orally, sublingually, rectally, vaginally, intramuscularly, subcutaneously, intravenously, intratumoraly, transsdermaly mucosally, topically or by other dosing mechanisms, including but not limited to transdermal patches, liposomal formulations, glycoprotein formulations, and other known delivery technologies, in two or more doses spaced 4-72 hours apart, where the first dose is in a moderate range (1 to 200 mcg/kg body weight in humans or a more preferred dose of 5 to 50 micrograms per kg body weight) sufficient to activate innate immunity and induce measurable but not excessive levels of serum interferon and certain other cytokines and chemokines;
• and the second, lower dose is in the maximally effective range (1 to 50 mcg/kg in humans) for unblocking and/or stimulation of certain genes and interferon and dsRNA inducible enzyme systems, including the PKR and 2′5′OAS, as well as activation and maturation of dendritic and other immune cells.