VLP stabilized vaccine compositions
AssigneeInventprise, LLC
InventorSubhash V. Kapre
Life of this patent
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Abstract
The invention is directed to compositions and methods for the stabilization of viral and bacterial vaccines. Vaccines of the invention are contained in VLPs with stabilizing agents such as, for example, sugar alcohols (e.g., sorbitol) and degraded gelatins. Preferably the gelatin has an average molecular weight of 10,000 kilodaltons or less. These vaccines have a substantially improved thermostability as well as long term stability. The invention is also directed to the manufacture of a vaccine or the invention and methods for the administration of a vaccine of the invention to patients.
Claims32
A liquid composition comprising virus-like particles (VLPs), an immunogenic component and a stabilizing agent comprised of one or more gelatins degraded to an average molecular weight of about twenty kilodaltons or less, wherein the immunogenic component is a Staphylococcal polysaccharide antigen, wherein the composition is maintained as a liquid and as a liquid stored at ambient temperatures without significant loss of immunogenic activity, and wherein the composition has not been maintained in a non-liquid state.
A liquid composition comprising one or more structural components that form virus-like particles (VLPs) and an immunogenic component, wherein the composition comprises a degraded gelatin with an average molecular weight of from about twenty kilodaltons to about 5 kilodaltons, the one or more structural components are obtained from a virus, and the immunogenic component is a viral antigen selected from the group of viruses consisting of enterovirus, hepatitis virus, human immunodeficiency virus (HIV), human papilloma virus (HPV), influenza virus, pertussis virus, rubella virus, tetanus, varicella virus (VZV), flavivirus, West Nile virus, dengue virus, tick-borne encephalitis virus, yellow fever virus, and Zika virus, wherein the composition is maintained as a liquid and as a liquid stored at ambient temperatures without significant loss of immunogenic activity, and wherein the composition has not been maintained in a non-liquid state.
A liquid composition comprising one or more structural components obtained or derived from hepatitis virus or human papilloma virus that form virus-like particles (VLPs) and an immunogenic component and a stabilizing agent, wherein the stabilizing agent is a degraded gelatin with an average molecular weight of twenty kilodaltons or less, and does not contain an aluminum compound, wherein the immunogenic component is a Streptococcal polysaccharide antigen and the composition is stored at ambient temperatures as a liquid without significant loss of immunogenic activity, and wherein the composition has not been maintained in a non-liquid state.
Dependencies are inferred from the claim text.